Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)

"A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's Disease"

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04928287

Acronym

Enrollment

Registered

2021-06-16

Start date

2021-06-28

Completion date

2023-02-06

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple HB-adMSCs vs Placebo for the treatment of Parkinson's disease. The trial includes a screening period of up to 4 weeks, a 32-week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration. This clinical trial will be open to enroll 24 eligible participants diagnosed with Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible participants are identified based on eligibility criteria, a screening visit will be scheduled. Informed consent form will be given to the study participants and signed before any study procedures. Informed consent form will include information about the clinical trial and some aspects should be considered during this process.

Interventions

BIOLOGICALHB-adMSCs

HB-adMSCs will be administered intravenously to study participants who qualify.

OTHERPlacebo

Placebo will be administered intravenously to study participants who qualify.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Study subjects, investigators and study staff will be blinded to the assigned treatment.

Intervention model description

A parallel study is a type of clinical study where two groups of treatments, A (HB-adMSCs) and B (Placebo), are given so that one group receives only A while another group receives only B.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* A study participant will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male and female participants 18 - 75 years of age. 2. Study participant must have been diagnosed with early and/or moderate Parkinson's disease at least 6 months before study participation. 3. Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences. 4. Study participants should be able to read, understand and to provide written consent. 5. Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed. 6. Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration. 7. Male participants if their sexual partners can become pregnant should use a method of contraception during study participation and for 6 months after the last administration of the investigated product. 8. Study participant is able and willing to comply with the requirements of this clinical trial.

Exclusion criteria

* A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply: 1. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures. 2. Study participants with advanced Parkinson's disease described as, severe disability, wheelchair bound or bedridden. 3. Study participant has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma. 4. Study participant has known alcoholic addiction or dependency or has current substance use or abuse. 5. Study participant has 1 or more significant concurrent medical conditions (verified by medical records), including the following: * Poorly controlled diabetes mellitus (PCDM) defined as history of deficient standard of care treatment and/or pre-prandial glucose \>130mg/dl during screening visit or post-prandial glucose \>200mg/dl. * Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR \< 59mL/min/1.73m2. * Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit. * Any medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina. * Medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure \> 180/120 mm/Hg during screening visit. * Medical history of inherited thrombophilias, recent major general surgery, (within 12 months before the Screening), lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips or femur, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach). * History of brain surgery for Parkinson's disease. 6. Study participant has received any stem cell treatment within 6 months before first dose of investigational product other than stem cells produced by Hope Biosciences. 7. Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines. 8. Study participant has a laboratory abnormality during screening, including the following: * White blood cell count \< 3000/mm3 * Platelet count \< 80,000mm3 * Absolute neutrophil count \< 1500/mm3 * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10 upper limit of normal (ULN) x 1.5 9. Study participant has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study. 10. Study participant is unlikely to complete the study or adhere to the study procedures. 11. Study participant with known concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection. 12. Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments. 13. Study participant with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product. 14. Male study participants who plan to donate sperm during the study or within 6 months after the last dose. Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study or within 6 months after the last dose. 15. Study participants who are determined by the Investigator to be unsuitable for study enrollment for other reasons

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in MDS-UPDRS Part II.	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Laboratory Values. CBC (% of WBC)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of % of white blood cell count.
Laboratory Values. CBC (10^9 Cells/L)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with units of 10\^9 cells/L (Leukocytes, Platelets)
Laboratory Values. CBC (10^12 Cells/L)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with units of 10\^12 cells/L.
Laboratory Values. CBC (pg)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of pg.
Laboratory Values. CBC (fL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of fL.
Laboratory Values. CBC (g/dL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of g/dL.
Laboratory Values. CBC (% Difference in Volume and Size of RBC)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of % difference in volume and size of RBC
Laboratory Values. CBC (% of Total Blood Cell Count)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CBC laboratory values with unit of % of total blood cell count.
Vital Signs. - Blood Pressure (mmHg)	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Change from baseline in Blood Pressure.
Weight in kg.	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Change from baseline in Weight in kg.
Laboratory Values. CMP (mg/dL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Change from baseline in CMP values with units of mg/dL
Laboratory Values. CMP (g/dL)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of g/dL
Laboratory Values. CMP (IU/L)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of IU/L.
Laboratory Values. CMP (mL/Min/1.73m^2)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.
Laboratory Values. CMP (mmol/L)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of mmol/L.
Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)
Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)
Laboratory Values. Coagulation Panel (Seconds)	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in Coagulation Panel values with units of seconds.
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	Baseline (Week 0), Week 24, and End of Study (Week 52)	Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).
Vital Signs. - Respiratory Rate (Breaths Per Minute)	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Changes from Baseline in Respiratory Rate.
Vital Signs. - Heart Rate (Beats Per Minute)	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Change from baseline in Heart Rate.
Vital Signs. - Body Temperature (Celsius )	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Change from baseline in Body Temperature.

Secondary

Measure	Time frame	Description
Change From Baseline in MDS-UPDRS Part I.	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Change From Baseline in MDS-UPDRS Part III.	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part III tests "Motor examination". Motor Examination includes speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage. There are 18 items included in Part III. Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Change From Baseline in MDS-UPDRS Part IV.	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Change From Baseline in Neuro-QOL. - Communication	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Communication - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The communication short form has 5 questions regarding communicative abilities of the patient, and each question ranges from 0 points to 5 points (making the total 25 points). A higher score represents a better outcome.
Change From Baseline in Neuro-QOL. - Social Roles and Activities	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Ability to Participate in Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Ability to Participate in Social Roles and Activities" short form has 8 questions regarding social abilities of the patient (familial and friend relationships), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.
Changes From Baseline in Neuro-QOL. - Anxiety	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Anxiety - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Anxiety" short form has 8 questions regarding the anxiety level of the patient (inquiring about level of uneasiness and worry), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.
Change From Baseline in Neuro-QOL. - Depression	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Depression - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Depression" short form has 8 questions regarding the depression level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.
Change From Baseline in Neuro-QOL. - Dyscontrol	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Emotional and Behavioral Dyscontrol - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Dyscontrol" short form has 8 questions regarding the emotional and behavioral dyscontrol level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.
Changes From Baseline in Neuro-QOL. - Fatigue	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Fatigue - Short Form Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Fatigue" short form has 8 questions regarding the Fatigue level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.
Change From Baseline in Neuro-QOL. - Mobility	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Lower Extremity Function (Mobility) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Mobility" short form has 8 questions regarding the Lower Extremity Function (Mobility) level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.
Change From Baseline in Neuro-QOL. - Well-Being	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Positive Affect and Well-Being - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Positive Affect and Well-Being" short form has 8 questions regarding the well-being level of the patient, and each question ranges from 0 points to 5 points (making the total 45 points). A higher score represents a better outcome.
Change From Baseline in Neuro-QOL. - Sleep	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Sleep Disturbance - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Sleep disturbance" short form has 8 questions regarding the sleep level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.
Change From Baseline in Neuro-QOL. - Fine Motor	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Upper Extremity Function (Fine Motor, ADL) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Upper Extremity Function (Fine Motor, ADL)" short form has 8 questions regarding the fine motor levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.
Change From Baseline in Neuro-QOL. - Stigma	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Stigma-Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Stigma" short form has 8 questions regarding the stigma levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.
Change From Baseline in Neuro-QOL. - Social Roles	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Satisfaction with Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Satisfaction with Social Roles and Activities" short form has 8 questions regarding the satisfaction levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.
Change From Baseline in Neuro-QOL. - Cognition	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Cognition Function- Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Cognition Function" short form has 8 questions regarding the cognition function levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	The Parkinson's disease fatigue scale (PFS-16) is an 16 question assessment that measures the level of fatigue in patients diagnosed with Parkinson's disease. Each question has 5 answer choices established as "strongly disagree", "disagree", "do not agree or disagree", "agree", and "strongly agree", which are scored as 1 to 5, respectively, making the total score from 16 to 80 points. Higher score represents a worse outcome.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100. The final reported score (summary index) is calculated by averaging the 8 scaled scores. Higher score represents a worse outcome.
Change From Baseline in Total Visual Analog Scale	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Visual Analog Scale for Pain and Muscle Spasm. The pain and muscle spasm VAS is a unidimensional measure of pain/ muscle spasm intensity, used to record patients' pain progression and muscle spasm progression, or compare pain and muscle spasm severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark summed with the distance (mm) on the 10-cm line between the "no muscle spasm" anchor and the patient's mark, providing a range of scores from 0-200. A higher score indicates greater pain/spasm intensity.
Change From Baseline in Dosage of Carbidopa/Levodopa	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Dosage of medications.
Change From Baseline in Vital Signs. - Oxygen Saturation.	Baseline through Week 32, Follow-up at week 42 and End of Study at week 52	Changes in Oxygen Saturation.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDjamchid Lotfi, MD

Hope Biosciences Stem Cell Research Foundation

Participant flow

Participants by arm

Arm	Count
HB-adMSCs Autologous Hope Biosciences adipose derived mesenchymal stem cells. HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify.	15
Placebo Sterile Saline Solution 0.9% HB-adMSCs: HB-adMSCs will be administered intravenously to study participants who qualify. Placebo: Placebo will be administered intravenously to study participants who qualify.	9
Total	24

Baseline characteristics

Characteristic	HB-adMSCs	Total	Placebo
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	7 Participants	10 Participants	3 Participants
Age, Categorical Between 18 and 65 years	8 Participants	14 Participants	6 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 11.29	60.6 years STANDARD_DEVIATION 10.29	61.1 years STANDARD_DEVIATION 8.99
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	3 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants	21 Participants	8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Height	174.41 centimeter STANDARD_DEVIATION 8.572	174.09 centimeter STANDARD_DEVIATION 9.02	173.57 centimeter STANDARD_DEVIATION 10.239
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	14 Participants	22 Participants	8 Participants
Region of Enrollment United States	15 participants	24 participants	9 participants
Sex: Female, Male Female	8 Participants	12 Participants	4 Participants
Sex: Female, Male Male	7 Participants	12 Participants	5 Participants
Weight	79.56 kilograms STANDARD_DEVIATION 23.389	79.33 kilograms STANDARD_DEVIATION 22.149	78.94 kilograms STANDARD_DEVIATION 21.28

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 9
other Total, other adverse events	15 / 15	9 / 9
serious Total, serious adverse events	1 / 15	0 / 9

Outcome results

Primary

Change From Baseline in MDS-UPDRS Part II.

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of the following 4 segments. Part II tests Motor Aspects of Experiences of Daily Living. Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in MDS-UPDRS Part II.	Baseline	10.00 score on a scale (52 points total)	Standard Deviation 6.99
HB-adMSCs	Change From Baseline in MDS-UPDRS Part II.	Week 4	-1.87 score on a scale (52 points total)	Standard Deviation 2.83
HB-adMSCs	Change From Baseline in MDS-UPDRS Part II.	Week 8	-2.07 score on a scale (52 points total)	Standard Deviation 3.67
HB-adMSCs	Change From Baseline in MDS-UPDRS Part II.	Week 16	-2.00 score on a scale (52 points total)	Standard Deviation 3.23
HB-adMSCs	Change From Baseline in MDS-UPDRS Part II.	Week 24	-1.33 score on a scale (52 points total)	Standard Deviation 3.79
HB-adMSCs	Change From Baseline in MDS-UPDRS Part II.	Week 32	-0.73 score on a scale (52 points total)	Standard Deviation 3.84
HB-adMSCs	Change From Baseline in MDS-UPDRS Part II.	Week 42	-0.33 score on a scale (52 points total)	Standard Deviation 4.19
HB-adMSCs	Change From Baseline in MDS-UPDRS Part II.	Week 52	1.20 score on a scale (52 points total)	Standard Deviation 6.61
Placebo	Change From Baseline in MDS-UPDRS Part II.	Week 52	1.11 score on a scale (52 points total)	Standard Deviation 4.37
Placebo	Change From Baseline in MDS-UPDRS Part II.	Baseline	7.33 score on a scale (52 points total)	Standard Deviation 5.15
Placebo	Change From Baseline in MDS-UPDRS Part II.	Week 24	-1.44 score on a scale (52 points total)	Standard Deviation 3
Placebo	Change From Baseline in MDS-UPDRS Part II.	Week 4	0.11 score on a scale (52 points total)	Standard Deviation 2.71
Placebo	Change From Baseline in MDS-UPDRS Part II.	Week 42	0.56 score on a scale (52 points total)	Standard Deviation 2.46
Placebo	Change From Baseline in MDS-UPDRS Part II.	Week 8	-1.56 score on a scale (52 points total)	Standard Deviation 3.61
Placebo	Change From Baseline in MDS-UPDRS Part II.	Week 32	-0.44 score on a scale (52 points total)	Standard Deviation 2.96
Placebo	Change From Baseline in MDS-UPDRS Part II.	Week 16	-0.67 score on a scale (52 points total)	Standard Deviation 3.24

Primary

Laboratory Values. CBC (10^12 Cells/L)

Changes from baseline in CBC laboratory values with units of 10\^12 cells/L.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CBC (10^12 Cells/L)	Erythrocytes (10^12 cells /L) Baseline Value	4.425 10^12 cells/L	Standard Deviation 0.5909
HB-adMSCs	Laboratory Values. CBC (10^12 Cells/L)	Erythrocytes (10^12 cells/L ) Week 24	0.021 10^12 cells/L	Standard Deviation 0.2671
HB-adMSCs	Laboratory Values. CBC (10^12 Cells/L)	Erythrocytes (10^12 cells/L ) Week 52	0.109 10^12 cells/L	Standard Deviation 0.3503
Placebo	Laboratory Values. CBC (10^12 Cells/L)	Erythrocytes (10^12 cells /L) Baseline Value	4.723 10^12 cells/L	Standard Deviation 0.4661
Placebo	Laboratory Values. CBC (10^12 Cells/L)	Erythrocytes (10^12 cells/L ) Week 24	0.129 10^12 cells/L	Standard Deviation 0.2073
Placebo	Laboratory Values. CBC (10^12 Cells/L)	Erythrocytes (10^12 cells/L ) Week 52	0.024 10^12 cells/L	Standard Deviation 0.1843

Primary

Laboratory Values. CBC (10^9 Cells/L)

Changes from baseline in CBC laboratory values with units of 10\^9 cells/L (Leukocytes, Platelets)

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CBC (10^9 Cells/L)	Platelets (10^9 cells/L) Baseline Value	243.3 10^9 cells/L	Standard Deviation 52.38
HB-adMSCs	Laboratory Values. CBC (10^9 Cells/L)	Platelets (10^9 cells/L) Week 24	9.1 10^9 cells/L	Standard Deviation 32.96
HB-adMSCs	Laboratory Values. CBC (10^9 Cells/L)	Platelets (10^9 cells/L) Week 52	8.1 10^9 cells/L	Standard Deviation 23.48
HB-adMSCs	Laboratory Values. CBC (10^9 Cells/L)	Leukocytes (10^9 cells/L) Baseline Value	5.83 10^9 cells/L	Standard Deviation 1.891
HB-adMSCs	Laboratory Values. CBC (10^9 Cells/L)	Leukocytes (10^9 cells/L) Week 24	-0.36 10^9 cells/L	Standard Deviation 1.64
HB-adMSCs	Laboratory Values. CBC (10^9 Cells/L)	Leukocytes (10^9 cells/L) Week 52	0.09 10^9 cells/L	Standard Deviation 1.615
Placebo	Laboratory Values. CBC (10^9 Cells/L)	Leukocytes (10^9 cells/L) Week 24	-0.08 10^9 cells/L	Standard Deviation 1.335
Placebo	Laboratory Values. CBC (10^9 Cells/L)	Platelets (10^9 cells/L) Baseline Value	209.4 10^9 cells/L	Standard Deviation 44.46
Placebo	Laboratory Values. CBC (10^9 Cells/L)	Leukocytes (10^9 cells/L) Baseline Value	5.47 10^9 cells/L	Standard Deviation 1.267
Placebo	Laboratory Values. CBC (10^9 Cells/L)	Platelets (10^9 cells/L) Week 24	-12.1 10^9 cells/L	Standard Deviation 12.94
Placebo	Laboratory Values. CBC (10^9 Cells/L)	Leukocytes (10^9 cells/L) Week 52	-0.11 10^9 cells/L	Standard Deviation 0.885
Placebo	Laboratory Values. CBC (10^9 Cells/L)	Platelets (10^9 cells/L) Week 52	0.8 10^9 cells/L	Standard Deviation 7.24

Primary

Laboratory Values. CBC (% Difference in Volume and Size of RBC)

Changes from baseline in CBC laboratory values with unit of % difference in volume and size of RBC

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CBC (% Difference in Volume and Size of RBC)	Erythrocytes Distribution Width (%) Baseline Value	12.39 % difference in volume and size of RBC	Standard Deviation 0.491
HB-adMSCs	Laboratory Values. CBC (% Difference in Volume and Size of RBC)	Erythrocytes Distribution Width (%) Week 24	0.33 % difference in volume and size of RBC	Standard Deviation 0.339
HB-adMSCs	Laboratory Values. CBC (% Difference in Volume and Size of RBC)	Erythrocytes Distribution Width (%) Week 52	0.16 % difference in volume and size of RBC	Standard Deviation 0.364
Placebo	Laboratory Values. CBC (% Difference in Volume and Size of RBC)	Erythrocytes Distribution Width (%) Baseline Value	12.64 % difference in volume and size of RBC	Standard Deviation 0.59
Placebo	Laboratory Values. CBC (% Difference in Volume and Size of RBC)	Erythrocytes Distribution Width (%) Week 24	0.68 % difference in volume and size of RBC	Standard Deviation 1.394
Placebo	Laboratory Values. CBC (% Difference in Volume and Size of RBC)	Erythrocytes Distribution Width (%) Week 52	0.22 % difference in volume and size of RBC	Standard Deviation 0.233

Primary

Laboratory Values. CBC (fL)

Changes from baseline in CBC laboratory values with unit of fL.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CBC (fL)	Ery. Mean Corpuscular Volume (fL) Baseline value	90.83 fL	Standard Deviation 4.404
HB-adMSCs	Laboratory Values. CBC (fL)	Ery. Mean Corpuscular Volume (fL) Week 24	-0.85 fL	Standard Deviation 1.968
HB-adMSCs	Laboratory Values. CBC (fL)	Ery. Mean Corpuscular Volume (fL) Week 52	0.12 fL	Standard Deviation 2.034
Placebo	Laboratory Values. CBC (fL)	Ery. Mean Corpuscular Volume (fL) Baseline value	88.30 fL	Standard Deviation 3.508
Placebo	Laboratory Values. CBC (fL)	Ery. Mean Corpuscular Volume (fL) Week 24	-0.46 fL	Standard Deviation 1.074
Placebo	Laboratory Values. CBC (fL)	Ery. Mean Corpuscular Volume (fL) Week 52	0.53 fL	Standard Deviation 1.111

Primary

Laboratory Values. CBC (g/dL)

Changes from baseline in CBC laboratory values with unit of g/dL.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CBC (g/dL)	Ery. Mean Corpuscular HGB Concentration (g/dL) Baseline Value	33.89 g/dL	Standard Deviation 0.718
HB-adMSCs	Laboratory Values. CBC (g/dL)	Ery. Mean Corpuscular HGB Concentration (g/dL) Week 24	0.34 g/dL	Standard Deviation 0.741
HB-adMSCs	Laboratory Values. CBC (g/dL)	Ery. Mean Corpuscular HGB Concentration (g/dL) Week 52	-0.07 g/dL	Standard Deviation 1.306
HB-adMSCs	Laboratory Values. CBC (g/dL)	Hemoglobin (g/dL) Baseline Value	13.57 g/dL	Standard Deviation 1.435
HB-adMSCs	Laboratory Values. CBC (g/dL)	Hemoglobin (g/dL) Week 24	0.09 g/dL	Standard Deviation 0.798
HB-adMSCs	Laboratory Values. CBC (g/dL)	Hemoglobin (g/dL) Week 52	0.33 g/dL	Standard Deviation 0.893
Placebo	Laboratory Values. CBC (g/dL)	Hemoglobin (g/dL) Week 24	0.33 g/dL	Standard Deviation 0.561
Placebo	Laboratory Values. CBC (g/dL)	Ery. Mean Corpuscular HGB Concentration (g/dL) Baseline Value	34.03 g/dL	Standard Deviation 0.93
Placebo	Laboratory Values. CBC (g/dL)	Hemoglobin (g/dL) Baseline Value	14.16 g/dL	Standard Deviation 1.041
Placebo	Laboratory Values. CBC (g/dL)	Ery. Mean Corpuscular HGB Concentration (g/dL) Week 24	0.06 g/dL	Standard Deviation 0.781
Placebo	Laboratory Values. CBC (g/dL)	Hemoglobin (g/dL) Week 52	-0.06 g/dL	Standard Deviation 0.652
Placebo	Laboratory Values. CBC (g/dL)	Ery. Mean Corpuscular HGB Concentration (g/dL) Week 52	-0.54 g/dL	Standard Deviation 1.242

Primary

Laboratory Values. CBC (% of Total Blood Cell Count)

Changes from baseline in CBC laboratory values with unit of % of total blood cell count.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CBC (% of Total Blood Cell Count)	Hematocrit (%) Baseline Value	40.01 % of total blood cell count	Standard Deviation 4.348
HB-adMSCs	Laboratory Values. CBC (% of Total Blood Cell Count)	Hematocrit (%) Week 24	-0.15 % of total blood cell count	Standard Deviation 2.143
HB-adMSCs	Laboratory Values. CBC (% of Total Blood Cell Count)	Hematocrit (%) Week 52	1.13 % of total blood cell count	Standard Deviation 3.297
Placebo	Laboratory Values. CBC (% of Total Blood Cell Count)	Hematocrit (%) Baseline Value	41.63 % of total blood cell count	Standard Deviation 3.403
Placebo	Laboratory Values. CBC (% of Total Blood Cell Count)	Hematocrit (%) Week 24	0.91 % of total blood cell count	Standard Deviation 1.9
Placebo	Laboratory Values. CBC (% of Total Blood Cell Count)	Hematocrit (%) Week 52	0.44 % of total blood cell count	Standard Deviation 1.519

Primary

Laboratory Values. CBC (% of WBC)

Changes from baseline in CBC laboratory values with unit of % of white blood cell count.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Eosinophils (%) Week 24	0.24 % of white blood cell count	Standard Deviation 1.962
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Lymphocytes (%) Week 52	-0.06 % of white blood cell count	Standard Deviation 6.194
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Basophils (%) Week 24	0.05 % of white blood cell count	Standard Deviation 1.196
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Monocytes (%) Baseline value	7.33 % of white blood cell count	Standard Deviation 2.609
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Eosinophils (%) Week 52	-0.03 % of white blood cell count	Standard Deviation 1.649
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Monocytes (%) Week 24	-0.87 % of white blood cell count	Standard Deviation 3.229
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Eosinophils (%) Baseline Value	1.49 % of white blood cell count	Standard Deviation 1.838
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Monocytes (%) Week 52	-0.49 % of white blood cell count	Standard Deviation 3.67
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Lymphocytes (%) Baseline Value	32.35 % of white blood cell count	Standard Deviation 7.02
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Neutrophils (%) Baseline Value	56.31 % of white blood cell count	Standard Deviation 8.385
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Basophils (%) Week 52	0.29 % of white blood cell count	Standard Deviation 1.92
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Neutrophils (%) Week 24	0.43 % of white blood cell count	Standard Deviation 8.622
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Lymphocytes (%) Week 24	0.13 % of white blood cell count	Standard Deviation 9.277
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Neutrophils (%) Week 52	0.29 % of white blood cell count	Standard Deviation 7.828
HB-adMSCs	Laboratory Values. CBC (% of WBC)	Basophils (%) Baseline Value	0.73 % of white blood cell count	Standard Deviation 0.947
Placebo	Laboratory Values. CBC (% of WBC)	Neutrophils (%) Week 52	-0.62 % of white blood cell count	Standard Deviation 4.788
Placebo	Laboratory Values. CBC (% of WBC)	Basophils (%) Baseline Value	0.87 % of white blood cell count	Standard Deviation 0.752
Placebo	Laboratory Values. CBC (% of WBC)	Basophils (%) Week 24	0.27 % of white blood cell count	Standard Deviation 0.994
Placebo	Laboratory Values. CBC (% of WBC)	Basophils (%) Week 52	0.16 % of white blood cell count	Standard Deviation 1.078
Placebo	Laboratory Values. CBC (% of WBC)	Eosinophils (%) Baseline Value	2.50 % of white blood cell count	Standard Deviation 1.752
Placebo	Laboratory Values. CBC (% of WBC)	Eosinophils (%) Week 24	0.03 % of white blood cell count	Standard Deviation 2.492
Placebo	Laboratory Values. CBC (% of WBC)	Eosinophils (%) Week 52	-0.18 % of white blood cell count	Standard Deviation 2.08
Placebo	Laboratory Values. CBC (% of WBC)	Lymphocytes (%) Baseline Value	33.33 % of white blood cell count	Standard Deviation 9.462
Placebo	Laboratory Values. CBC (% of WBC)	Lymphocytes (%) Week 24	-0.51 % of white blood cell count	Standard Deviation 5.113
Placebo	Laboratory Values. CBC (% of WBC)	Lymphocytes (%) Week 52	-1.17 % of white blood cell count	Standard Deviation 6.361
Placebo	Laboratory Values. CBC (% of WBC)	Monocytes (%) Baseline value	6.72 % of white blood cell count	Standard Deviation 4.615
Placebo	Laboratory Values. CBC (% of WBC)	Monocytes (%) Week 24	0.56 % of white blood cell count	Standard Deviation 4.073
Placebo	Laboratory Values. CBC (% of WBC)	Monocytes (%) Week 52	1.81 % of white blood cell count	Standard Deviation 3.538
Placebo	Laboratory Values. CBC (% of WBC)	Neutrophils (%) Baseline Value	56.24 % of white blood cell count	Standard Deviation 8.213
Placebo	Laboratory Values. CBC (% of WBC)	Neutrophils (%) Week 24	-0.34 % of white blood cell count	Standard Deviation 8.259

Primary

Laboratory Values. CBC (pg)

Changes from baseline in CBC laboratory values with unit of pg.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CBC (pg)	Ery. Mean Corpuscular Hemoglobin Baseline Value	30.80 pg	Standard Deviation 1.838
HB-adMSCs	Laboratory Values. CBC (pg)	Ery. Mean Corpuscular Hemoglobin Week 24	0.01 pg	Standard Deviation 0.816
HB-adMSCs	Laboratory Values. CBC (pg)	Ery. Mean Corpuscular Hemoglobin Week 52	-0.06 pg	Standard Deviation 1.005
Placebo	Laboratory Values. CBC (pg)	Ery. Mean Corpuscular Hemoglobin Baseline Value	30.08 pg	Standard Deviation 1.949
Placebo	Laboratory Values. CBC (pg)	Ery. Mean Corpuscular Hemoglobin Week 24	-0.12 pg	Standard Deviation 0.616
Placebo	Laboratory Values. CBC (pg)	Ery. Mean Corpuscular Hemoglobin Week 52	-0.32 pg	Standard Deviation 0.874

Primary

Laboratory Values. CMP (g/dL)

Changes from baseline in CMP laboratory values with units of g/dL

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CMP (g/dL)	Globulin (g/dL) Week 24	-0.04 g/dL	Standard Deviation 0.206
HB-adMSCs	Laboratory Values. CMP (g/dL)	Globulin (g/dL) Week 52	-0.01 g/dL	Standard Deviation 0.264
HB-adMSCs	Laboratory Values. CMP (g/dL)	Albumin (g/dL) Week 52	-0.01 g/dL	Standard Deviation 0.267
HB-adMSCs	Laboratory Values. CMP (g/dL)	Protein (g/dL) Baseline Value	7.11 g/dL	Standard Deviation 0.391
HB-adMSCs	Laboratory Values. CMP (g/dL)	Albumin (g/dL) Week 24	-0.03 g/dL	Standard Deviation 0.246
HB-adMSCs	Laboratory Values. CMP (g/dL)	Protein (g/dL) Week 24	-0.07 g/dL	Standard Deviation 0.406
HB-adMSCs	Laboratory Values. CMP (g/dL)	Globulin (g/dL) Baseline Value	2.61 g/dL	Standard Deviation 0.328
HB-adMSCs	Laboratory Values. CMP (g/dL)	Protein (g/dL) Week 52	-0.03 g/dL	Standard Deviation 0.394
HB-adMSCs	Laboratory Values. CMP (g/dL)	Albumin (g/dL) Baseline Value	4.51 g/dL	Standard Deviation 0.225
Placebo	Laboratory Values. CMP (g/dL)	Protein (g/dL) Week 52	-0.13 g/dL	Standard Deviation 0.25
Placebo	Laboratory Values. CMP (g/dL)	Albumin (g/dL) Baseline Value	4.53 g/dL	Standard Deviation 0.278
Placebo	Laboratory Values. CMP (g/dL)	Albumin (g/dL) Week 24	0.08 g/dL	Standard Deviation 0.222
Placebo	Laboratory Values. CMP (g/dL)	Albumin (g/dL) Week 52	-0.04 g/dL	Standard Deviation 0.167
Placebo	Laboratory Values. CMP (g/dL)	Globulin (g/dL) Baseline Value	2.42 g/dL	Standard Deviation 0.497
Placebo	Laboratory Values. CMP (g/dL)	Globulin (g/dL) Week 52	-0.09 g/dL	Standard Deviation 0.176
Placebo	Laboratory Values. CMP (g/dL)	Protein (g/dL) Baseline Value	6.96 g/dL	Standard Deviation 0.52
Placebo	Laboratory Values. CMP (g/dL)	Protein (g/dL) Week 24	0.14 g/dL	Standard Deviation 0.3
Placebo	Laboratory Values. CMP (g/dL)	Globulin (g/dL) Week 24	0.07 g/dL	Standard Deviation 0.173

Primary

Laboratory Values. CMP (IU/L)

Changes from baseline in CMP laboratory values with units of IU/L.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CMP (IU/L)	Alkaline Phosphatase (IU/L) Week 24	2.3 IU/L	Standard Deviation 10.25
HB-adMSCs	Laboratory Values. CMP (IU/L)	Alanine Aminotransferase (IU/L) Week 52	1.13 IU/L	Standard Deviation 5.657
HB-adMSCs	Laboratory Values. CMP (IU/L)	Alanine Aminotransferase (IU/L) Baseline Value	14.13 IU/L	Standard Deviation 8.007
HB-adMSCs	Laboratory Values. CMP (IU/L)	Aspartate Aminotransferase (IU/L) Baseline Value	20.3 IU/L	Standard Deviation 6.8
HB-adMSCs	Laboratory Values. CMP (IU/L)	Alkaline Phosphatase (IU/L) Week 52	2.3 IU/L	Standard Deviation 12.97
HB-adMSCs	Laboratory Values. CMP (IU/L)	Aspartate Aminotransferase (IU/L) Week 24	0.0 IU/L	Standard Deviation 4.34
HB-adMSCs	Laboratory Values. CMP (IU/L)	Alanine Aminotransferase (IU/L) Week 24	-0.13 IU/L	Standard Deviation 6.611
HB-adMSCs	Laboratory Values. CMP (IU/L)	Aspartate Aminotransferase (IU/L) Week 52	3.3 IU/L	Standard Deviation 9.52
HB-adMSCs	Laboratory Values. CMP (IU/L)	Alkaline Phosphatase (IU/L) Baseline Value	63.9 IU/L	Standard Deviation 17.33
Placebo	Laboratory Values. CMP (IU/L)	Aspartate Aminotransferase (IU/L) Week 52	0.8 IU/L	Standard Deviation 3.77
Placebo	Laboratory Values. CMP (IU/L)	Alkaline Phosphatase (IU/L) Baseline Value	75.7 IU/L	Standard Deviation 17.79
Placebo	Laboratory Values. CMP (IU/L)	Alkaline Phosphatase (IU/L) Week 24	3.7 IU/L	Standard Deviation 11.81
Placebo	Laboratory Values. CMP (IU/L)	Alkaline Phosphatase (IU/L) Week 52	-0.1 IU/L	Standard Deviation 6.41
Placebo	Laboratory Values. CMP (IU/L)	Alanine Aminotransferase (IU/L) Baseline Value	18.31 IU/L	Standard Deviation 11.221
Placebo	Laboratory Values. CMP (IU/L)	Alanine Aminotransferase (IU/L) Week 24	-2.43 IU/L	Standard Deviation 8.754
Placebo	Laboratory Values. CMP (IU/L)	Alanine Aminotransferase (IU/L) Week 52	0.68 IU/L	Standard Deviation 8.277
Placebo	Laboratory Values. CMP (IU/L)	Aspartate Aminotransferase (IU/L) Baseline Value	20.3 IU/L	Standard Deviation 6.32
Placebo	Laboratory Values. CMP (IU/L)	Aspartate Aminotransferase (IU/L) Week 24	-0.1 IU/L	Standard Deviation 3.1

Primary

Laboratory Values. CMP (mg/dL)

Change from baseline in CMP values with units of mg/dL

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Bilirubin (mg/dL) Baseline Value	0.46 mg/dL	Standard Deviation 0.15
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Creatinine (mg/dL) Week 52	-0.031 mg/dL	Standard Deviation 0.1058
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Calcium (mg/dL) Week 24	-0.06 mg/dL	Standard Deviation 0.374
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Glucose (mg/dL) Baseline Value	99.7 mg/dL	Standard Deviation 20.78
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Bilirubin (mg/dL) Week 52	0.05 mg/dL	Standard Deviation 0.177
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Glucose (mg/dL) Week 24	3.7 mg/dL	Standard Deviation 25.95
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Bilirubin (mg/dL) Week 24	0.03 mg/dL	Standard Deviation 0.139
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Glucose (mg/dL) Week 52	0.1 mg/dL	Standard Deviation 24.14
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Creatinine (mg/dL) Baseline Value	0.898 mg/dL	Standard Deviation 0.1243
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Urea Nitrogen (mg/dL) Baseline valuse	16.5 mg/dL	Standard Deviation 3.83
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Calcium (mg/dL) Baseline Value	9.63 mg/dL	Standard Deviation 0.41
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Urea Nitrogen (mg/dL) Week 24	0.4 mg/dL	Standard Deviation 2.61
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Creatinine (mg/dL) Week 24	-0.016 mg/dL	Standard Deviation 0.0755
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Urea Nitrogen (mg/dL) Week 52	0.0 mg/dL	Standard Deviation 3.44
HB-adMSCs	Laboratory Values. CMP (mg/dL)	Calcium (mg/dL) Week 52	0.09 mg/dL	Standard Deviation 0.252
Placebo	Laboratory Values. CMP (mg/dL)	Urea Nitrogen (mg/dL) Week 52	1.7 mg/dL	Standard Deviation 3.84
Placebo	Laboratory Values. CMP (mg/dL)	Bilirubin (mg/dL) Baseline Value	0.46 mg/dL	Standard Deviation 0.124
Placebo	Laboratory Values. CMP (mg/dL)	Bilirubin (mg/dL) Week 24	0.10 mg/dL	Standard Deviation 0.212
Placebo	Laboratory Values. CMP (mg/dL)	Bilirubin (mg/dL) Week 52	0.09 mg/dL	Standard Deviation 0.262
Placebo	Laboratory Values. CMP (mg/dL)	Calcium (mg/dL) Baseline Value	9.56 mg/dL	Standard Deviation 0.357
Placebo	Laboratory Values. CMP (mg/dL)	Calcium (mg/dL) Week 24	0.12 mg/dL	Standard Deviation 0.387
Placebo	Laboratory Values. CMP (mg/dL)	Calcium (mg/dL) Week 52	-0.07 mg/dL	Standard Deviation 0.442
Placebo	Laboratory Values. CMP (mg/dL)	Creatinine (mg/dL) Baseline Value	0.910 mg/dL	Standard Deviation 0.2579
Placebo	Laboratory Values. CMP (mg/dL)	Creatinine (mg/dL) Week 24	-0.019 mg/dL	Standard Deviation 0.2204
Placebo	Laboratory Values. CMP (mg/dL)	Creatinine (mg/dL) Week 52	-0.082 mg/dL	Standard Deviation 0.1664
Placebo	Laboratory Values. CMP (mg/dL)	Glucose (mg/dL) Baseline Value	100.4 mg/dL	Standard Deviation 16.96
Placebo	Laboratory Values. CMP (mg/dL)	Glucose (mg/dL) Week 24	10.0 mg/dL	Standard Deviation 24.17
Placebo	Laboratory Values. CMP (mg/dL)	Glucose (mg/dL) Week 52	0.4 mg/dL	Standard Deviation 20.88
Placebo	Laboratory Values. CMP (mg/dL)	Urea Nitrogen (mg/dL) Baseline valuse	15.4 mg/dL	Standard Deviation 4.1
Placebo	Laboratory Values. CMP (mg/dL)	Urea Nitrogen (mg/dL) Week 24	1.4 mg/dL	Standard Deviation 3.05

Primary

Laboratory Values. CMP (mL/Min/1.73m^2)

Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (mL/min/1.73m^2) Baseline Value	80.7 mL/min/1.73m^2	Standard Deviation 11.26
HB-adMSCs	Laboratory Values. CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (mL/min/1.73m^2) Week 24	4.6 mL/min/1.73m^2	Standard Deviation 6.57
HB-adMSCs	Laboratory Values. CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (mL/min/1.73m^2) Week 52	6.4 mL/min/1.73m^2	Standard Deviation 9.19
Placebo	Laboratory Values. CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (mL/min/1.73m^2) Baseline Value	81.9 mL/min/1.73m^2	Standard Deviation 16.07
Placebo	Laboratory Values. CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (mL/min/1.73m^2) Week 24	5.7 mL/min/1.73m^2	Standard Deviation 19.04
Placebo	Laboratory Values. CMP (mL/Min/1.73m^2)	Glomerular Filtration Rate (mL/min/1.73m^2) Week 52	9.9 mL/min/1.73m^2	Standard Deviation 14.5

Primary

Laboratory Values. CMP (mmol/L)

Changes from baseline in CMP laboratory values with units of mmol/L.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Chloride (mmol/L) Baseline Value	104.5 mmol/L	Standard Deviation 1.41
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Chloride (mmol/L) Week 24	0.5 mmol/L	Standard Deviation 1.73
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Chloride (mmol/L) Week 52	-0.3 mmol/L	Standard Deviation 2.31
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Carbon Dioxide (mmol/L) Baseline Value	25.7 mmol/L	Standard Deviation 2.28
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Carbon Dioxide (mmol/L) Week 24	-0.9 mmol/L	Standard Deviation 2.13
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Carbon Dioxide (mmol/L) Week 52	0.0 mmol/L	Standard Deviation 1.89
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Potassium (mmol/L) Baseline Value	4.29 mmol/L	Standard Deviation 0.287
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Potassium (mmol/L) Week 24	0.04 mmol/L	Standard Deviation 0.333
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Potassium (mmol/L) Week 52	0.02 mmol/L	Standard Deviation 0.273
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Sodium (mmol/L) Baseline Value	141.5 mmol/L	Standard Deviation 1.88
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Sodium (mmol/L) Week 24	-0.1 mmol/L	Standard Deviation 1.98
HB-adMSCs	Laboratory Values. CMP (mmol/L)	Sodium (mmol/L) Week 52	0.1 mmol/L	Standard Deviation 2.37
Placebo	Laboratory Values. CMP (mmol/L)	Sodium (mmol/L) Week 24	-1.9 mmol/L	Standard Deviation 1.54
Placebo	Laboratory Values. CMP (mmol/L)	Chloride (mmol/L) Baseline Value	104.4 mmol/L	Standard Deviation 2.19
Placebo	Laboratory Values. CMP (mmol/L)	Potassium (mmol/L) Baseline Value	4.31 mmol/L	Standard Deviation 0.19
Placebo	Laboratory Values. CMP (mmol/L)	Chloride (mmol/L) Week 24	-2.0 mmol/L	Standard Deviation 1.8
Placebo	Laboratory Values. CMP (mmol/L)	Sodium (mmol/L) Baseline Value	142.2 mmol/L	Standard Deviation 1.64
Placebo	Laboratory Values. CMP (mmol/L)	Chloride (mmol/L) Week 52	-0.1 mmol/L	Standard Deviation 2.42
Placebo	Laboratory Values. CMP (mmol/L)	Potassium (mmol/L) Week 24	-0.01 mmol/L	Standard Deviation 0.22
Placebo	Laboratory Values. CMP (mmol/L)	Carbon Dioxide (mmol/L) Baseline Value	26.2 mmol/L	Standard Deviation 2.54
Placebo	Laboratory Values. CMP (mmol/L)	Sodium (mmol/L) Week 52	-1.0 mmol/L	Standard Deviation 2
Placebo	Laboratory Values. CMP (mmol/L)	Carbon Dioxide (mmol/L) Week 24	-1.2 mmol/L	Standard Deviation 2.39
Placebo	Laboratory Values. CMP (mmol/L)	Potassium (mmol/L) Week 52	-0.01 mmol/L	Standard Deviation 0.209
Placebo	Laboratory Values. CMP (mmol/L)	Carbon Dioxide (mmol/L) Week 52	-0.2 mmol/L	Standard Deviation 2.22

Primary

Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))

Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Albumin/Globulin (RATIO) Baseline Value	1.75 Ratio: Albumin(g/dL) to Globulin(g/dL)	Standard Deviation 0.236
HB-adMSCs	Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Albumin/Globulin (RATIO) Week 24	0.03 Ratio: Albumin(g/dL) to Globulin(g/dL)	Standard Deviation 0.118
HB-adMSCs	Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Albumin/Globulin (RATIO) Week 52	0.02 Ratio: Albumin(g/dL) to Globulin(g/dL)	Standard Deviation 0.214
Placebo	Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Albumin/Globulin (RATIO) Baseline Value	1.96 Ratio: Albumin(g/dL) to Globulin(g/dL)	Standard Deviation 0.467
Placebo	Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Albumin/Globulin (RATIO) Week 24	-0.03 Ratio: Albumin(g/dL) to Globulin(g/dL)	Standard Deviation 0.15
Placebo	Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))	Albumin/Globulin (RATIO) Week 52	0.03 Ratio: Albumin(g/dL) to Globulin(g/dL)	Standard Deviation 0.166

Primary

Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))

Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Urea Nitrogen/Creatinine (RATIO) Baseline Value	18.5 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Deviation 4.49
HB-adMSCs	Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Urea Nitrogen/Creatinine (RATIO) Week 24	1.1 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Deviation 3.27
HB-adMSCs	Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Urea Nitrogen/Creatinine (RATIO) Week 52	0.8 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Deviation 3.91
Placebo	Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Urea Nitrogen/Creatinine (RATIO) Baseline Value	18.0 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Deviation 5.07
Placebo	Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Urea Nitrogen/Creatinine (RATIO) Week 24	1.1 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Deviation 5.73
Placebo	Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))	Urea Nitrogen/Creatinine (RATIO) Week 52	4.4 Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)	Standard Deviation 9

Primary

Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))

Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	Prothrombin Intl. Normalized Ratio (RATIO) Baseline Value	0.97 Ratio: PT (seconds) / MNPT (seconds)	Standard Deviation 0.049
HB-adMSCs	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	Prothrombin Intl. Normalized Ratio (RATIO) Week 24	0.01 Ratio: PT (seconds) / MNPT (seconds)	Standard Deviation 0.074
HB-adMSCs	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	Prothrombin Intl. Normalized Ratio (RATIO) Week 52	0.01 Ratio: PT (seconds) / MNPT (seconds)	Standard Deviation 0.035
Placebo	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	Prothrombin Intl. Normalized Ratio (RATIO) Baseline Value	0.96 Ratio: PT (seconds) / MNPT (seconds)	Standard Deviation 0.073
Placebo	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	Prothrombin Intl. Normalized Ratio (RATIO) Week 24	0.02 Ratio: PT (seconds) / MNPT (seconds)	Standard Deviation 0.067
Placebo	Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))	Prothrombin Intl. Normalized Ratio (RATIO) Week 52	-0.00 Ratio: PT (seconds) / MNPT (seconds)	Standard Deviation 0.05

Primary

Laboratory Values. Coagulation Panel (Seconds)

Changes from baseline in Coagulation Panel values with units of seconds.

Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Laboratory Values. Coagulation Panel (Seconds)	Prothrombin Time (sec) Baseline Value	13.20 seconds	Standard Deviation 0.332
HB-adMSCs	Laboratory Values. Coagulation Panel (Seconds)	Prothrombin Time (sec) Week 24	0.07 seconds	Standard Deviation 0.505
HB-adMSCs	Laboratory Values. Coagulation Panel (Seconds)	Prothrombin Time (sec) Week 52	0.13 seconds	Standard Deviation 0.294
HB-adMSCs	Laboratory Values. Coagulation Panel (Seconds)	Partial Thromboplastin Time (sec) Baseline Value	29.47 seconds	Standard Deviation 2.446
HB-adMSCs	Laboratory Values. Coagulation Panel (Seconds)	Partial Thromboplastin Time (sec) Week 24	0.42 seconds	Standard Deviation 1.026
HB-adMSCs	Laboratory Values. Coagulation Panel (Seconds)	Partial Thromboplastin Time (sec) Week 52	0.11 seconds	Standard Deviation 1.235
Placebo	Laboratory Values. Coagulation Panel (Seconds)	Partial Thromboplastin Time (sec) Week 24	-1.47 seconds	Standard Deviation 5.437
Placebo	Laboratory Values. Coagulation Panel (Seconds)	Prothrombin Time (sec) Baseline Value	13.22 seconds	Standard Deviation 0.814
Placebo	Laboratory Values. Coagulation Panel (Seconds)	Partial Thromboplastin Time (sec) Baseline Value	31.00 seconds	Standard Deviation 7.112
Placebo	Laboratory Values. Coagulation Panel (Seconds)	Prothrombin Time (sec) Week 24	-0.08 seconds	Standard Deviation 0.604
Placebo	Laboratory Values. Coagulation Panel (Seconds)	Partial Thromboplastin Time (sec) Week 52	-1.37 seconds	Standard Deviation 6.275
Placebo	Laboratory Values. Coagulation Panel (Seconds)	Prothrombin Time (sec) Week 52	-0.08 seconds	Standard Deviation 0.751

Primary

Vital Signs. - Blood Pressure (mmHg)

Change from baseline in Blood Pressure.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Systolic Baseline Value	129.0 mmHg	Standard Deviation 14.63
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Diastolic Baseline Value	79.7 mmHg	Standard Deviation 10.73
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 24	-5.1 mmHg	Standard Deviation 17.33
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 4	-1.3 mmHg	Standard Deviation 8.38
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 8	-5.9 mmHg	Standard Deviation 10.82
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 8	-2.5 mmHg	Standard Deviation 7.59
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 32	-5.8 mmHg	Standard Deviation 12.01
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 16	-2.3 mmHg	Standard Deviation 9.42
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 4	-1.9 mmHg	Standard Deviation 11.78
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 24	-3.1 mmHg	Standard Deviation 8.56
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 42	-4.3 mmHg	Standard Deviation 18.52
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 32	-1.9 mmHg	Standard Deviation 7.8
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 16	-3.9 mmHg	Standard Deviation 15.76
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 42	-1.2 mmHg	Standard Deviation 11.48
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 52	0.3 mmHg	Standard Deviation 8.09
HB-adMSCs	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 52	-5.9 mmHg	Standard Deviation 14.19
Placebo	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 52	-0.7 mmHg	Standard Deviation 7.05
Placebo	Vital Signs. - Blood Pressure (mmHg)	Systolic Baseline Value	135.6 mmHg	Standard Deviation 9.53
Placebo	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 4	-8.7 mmHg	Standard Deviation 6.22
Placebo	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 8	-6.3 mmHg	Standard Deviation 7.12
Placebo	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 16	-9.2 mmHg	Standard Deviation 5.93
Placebo	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 24	-6.0 mmHg	Standard Deviation 11.9
Placebo	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 32	-8.0 mmHg	Standard Deviation 11.11
Placebo	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 42	-11.6 mmHg	Standard Deviation 11.7
Placebo	Vital Signs. - Blood Pressure (mmHg)	Systolic Week 52	-7.0 mmHg	Standard Deviation 11.27
Placebo	Vital Signs. - Blood Pressure (mmHg)	Diastolic Baseline Value	79.8 mmHg	Standard Deviation 5.74
Placebo	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 4	-2.3 mmHg	Standard Deviation 5.34
Placebo	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 8	-1.0 mmHg	Standard Deviation 6.84
Placebo	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 16	-3.8 mmHg	Standard Deviation 6.67
Placebo	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 24	-3.6 mmHg	Standard Deviation 8.31
Placebo	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 32	-1.1 mmHg	Standard Deviation 6.05
Placebo	Vital Signs. - Blood Pressure (mmHg)	Diastolic Week 42	-4.0 mmHg	Standard Deviation 6.3

Primary

Vital Signs. - Body Temperature (Celsius )

Change from baseline in Body Temperature.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Vital Signs. - Body Temperature (Celsius )	Baseline Value	36.59 Celsius	Standard Deviation 0.245
HB-adMSCs	Vital Signs. - Body Temperature (Celsius )	Week 4	0.09 Celsius	Standard Deviation 0.351
HB-adMSCs	Vital Signs. - Body Temperature (Celsius )	Week 8	-0.02 Celsius	Standard Deviation 0.288
HB-adMSCs	Vital Signs. - Body Temperature (Celsius )	Week 16	0.09 Celsius	Standard Deviation 0.275
HB-adMSCs	Vital Signs. - Body Temperature (Celsius )	Week 24	0.05 Celsius	Standard Deviation 0.409
HB-adMSCs	Vital Signs. - Body Temperature (Celsius )	Week 32	0.12 Celsius	Standard Deviation 0.334
HB-adMSCs	Vital Signs. - Body Temperature (Celsius )	Week 42	0.13 Celsius	Standard Deviation 0.324
HB-adMSCs	Vital Signs. - Body Temperature (Celsius )	Week 52	0.05 Celsius	Standard Deviation 0.342
Placebo	Vital Signs. - Body Temperature (Celsius )	Week 52	0.03 Celsius	Standard Deviation 0.296
Placebo	Vital Signs. - Body Temperature (Celsius )	Baseline Value	36.54 Celsius	Standard Deviation 0.133
Placebo	Vital Signs. - Body Temperature (Celsius )	Week 24	-0.07 Celsius	Standard Deviation 0.316
Placebo	Vital Signs. - Body Temperature (Celsius )	Week 4	-0.03 Celsius	Standard Deviation 0.194
Placebo	Vital Signs. - Body Temperature (Celsius )	Week 42	-0.06 Celsius	Standard Deviation 0.35
Placebo	Vital Signs. - Body Temperature (Celsius )	Week 8	-0.11 Celsius	Standard Deviation 0.232
Placebo	Vital Signs. - Body Temperature (Celsius )	Week 32	0.11 Celsius	Standard Deviation 0.33
Placebo	Vital Signs. - Body Temperature (Celsius )	Week 16	-0.01 Celsius	Standard Deviation 0.247

Primary

Vital Signs. - Heart Rate (Beats Per Minute)

Change from baseline in Heart Rate.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Vital Signs. - Heart Rate (Beats Per Minute)	Week 52	5.3 beats/minute	Standard Deviation 10.54
HB-adMSCs	Vital Signs. - Heart Rate (Beats Per Minute)	Week 16	-2.1 beats/minute	Standard Deviation 8.46
HB-adMSCs	Vital Signs. - Heart Rate (Beats Per Minute)	Week 4	-1.3 beats/minute	Standard Deviation 6.27
HB-adMSCs	Vital Signs. - Heart Rate (Beats Per Minute)	Week 24	4.3 beats/minute	Standard Deviation 9.3
HB-adMSCs	Vital Signs. - Heart Rate (Beats Per Minute)	Baseline Value	70.7 beats/minute	Standard Deviation 10.8
HB-adMSCs	Vital Signs. - Heart Rate (Beats Per Minute)	Week 32	3.8 beats/minute	Standard Deviation 6.61
HB-adMSCs	Vital Signs. - Heart Rate (Beats Per Minute)	Week 8	-2.1 beats/minute	Standard Deviation 6.46
HB-adMSCs	Vital Signs. - Heart Rate (Beats Per Minute)	Week 42	3.5 beats/minute	Standard Deviation 6.22
Placebo	Vital Signs. - Heart Rate (Beats Per Minute)	Week 8	0.4 beats/minute	Standard Deviation 4.36
Placebo	Vital Signs. - Heart Rate (Beats Per Minute)	Week 52	0.7 beats/minute	Standard Deviation 4.21
Placebo	Vital Signs. - Heart Rate (Beats Per Minute)	Baseline Value	69.8 beats/minute	Standard Deviation 9.61
Placebo	Vital Signs. - Heart Rate (Beats Per Minute)	Week 4	1.9 beats/minute	Standard Deviation 8.72
Placebo	Vital Signs. - Heart Rate (Beats Per Minute)	Week 42	-0.3 beats/minute	Standard Deviation 7.68
Placebo	Vital Signs. - Heart Rate (Beats Per Minute)	Week 16	3.4 beats/minute	Standard Deviation 13.18
Placebo	Vital Signs. - Heart Rate (Beats Per Minute)	Week 24	1.1 beats/minute	Standard Deviation 6.95
Placebo	Vital Signs. - Heart Rate (Beats Per Minute)	Week 32	1.7 beats/minute	Standard Deviation 3.77

Primary

Vital Signs. - Respiratory Rate (Breaths Per Minute)

Changes from Baseline in Respiratory Rate.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Baseline Value	16.3 breaths/minute	Standard Deviation 0.7
HB-adMSCs	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 4	0 breaths/minute	Standard Deviation 0
HB-adMSCs	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 8	0.1 breaths/minute	Standard Deviation 1.19
HB-adMSCs	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 16	-0.1 breaths/minute	Standard Deviation 0.52
HB-adMSCs	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 24	0.1 breaths/minute	Standard Deviation 0.92
HB-adMSCs	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 32	0.7 breaths/minute	Standard Deviation 0.98
HB-adMSCs	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 42	0.4 breaths/minute	Standard Deviation 1.12
HB-adMSCs	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 52	0.3 breaths/minute	Standard Deviation 0.7
Placebo	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 52	0.7 breaths/minute	Standard Deviation 1
Placebo	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Baseline Value	16.0 breaths/minute	Standard Deviation 0
Placebo	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 24	0.4 breaths/minute	Standard Deviation 0.88
Placebo	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 4	0.2 breaths/minute	Standard Deviation 0.67
Placebo	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 42	0.4 breaths/minute	Standard Deviation 0.88
Placebo	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 8	0.2 breaths/minute	Standard Deviation 0.67
Placebo	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 32	0.7 breaths/minute	Standard Deviation 1
Placebo	Vital Signs. - Respiratory Rate (Breaths Per Minute)	Week 16	0.0 breaths/minute	Standard Deviation 0

Primary

Weight in kg.

Change from baseline in Weight in kg.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Weight in kg.	Baseline Value	79.65 kg	Standard Deviation 23.298
HB-adMSCs	Weight in kg.	Week 4	0.43 kg	Standard Deviation 1.551
HB-adMSCs	Weight in kg.	Week 8	1.75 kg	Standard Deviation 8.868
HB-adMSCs	Weight in kg.	Week 16	1.73 kg	Standard Deviation 9.009
HB-adMSCs	Weight in kg.	Week 24	-1.12 kg	Standard Deviation 2.995
HB-adMSCs	Weight in kg.	Week 32	-0.97 kg	Standard Deviation 3.58
HB-adMSCs	Weight in kg.	Week 42	-2.11 kg	Standard Deviation 5.441
HB-adMSCs	Weight in kg.	Week 52	-1.77 kg	Standard Deviation 5.046
Placebo	Weight in kg.	Week 52	0.60 kg	Standard Deviation 2.926
Placebo	Weight in kg.	Baseline Value	78.94 kg	Standard Deviation 21.28
Placebo	Weight in kg.	Week 24	1.04 kg	Standard Deviation 2.222
Placebo	Weight in kg.	Week 4	0.33 kg	Standard Deviation 1.038
Placebo	Weight in kg.	Week 42	3.48 kg	Standard Deviation 7.931
Placebo	Weight in kg.	Week 8	0.44 kg	Standard Deviation 0.981
Placebo	Weight in kg.	Week 32	1.02 kg	Standard Deviation 2.79
Placebo	Weight in kg.	Week 16	1.39 kg	Standard Deviation 2.354

Secondary

Change From Baseline in Dosage of Carbidopa/Levodopa

Dosage of medications.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Dosage of Carbidopa/Levodopa	Baseline Value	439.3 mg	Standard Deviation 599.96
HB-adMSCs	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 24	0 mg	Standard Deviation 0
HB-adMSCs	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 8	0 mg	Standard Deviation 0
HB-adMSCs	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 32	0 mg	Standard Deviation 0
HB-adMSCs	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 4	0 mg	Standard Deviation 0
HB-adMSCs	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 42	0 mg	Standard Deviation 0
HB-adMSCs	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 16	20. mg	Standard Deviation 77.46
HB-adMSCs	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 52	-10.0 mg	Standard Deviation 89.04
Placebo	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 16	11.1 mg	Standard Deviation 33.33
Placebo	Change From Baseline in Dosage of Carbidopa/Levodopa	Baseline Value	285.6 mg	Standard Deviation 273.92
Placebo	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 4	0 mg	Standard Deviation 0
Placebo	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 8	0 mg	Standard Deviation 0
Placebo	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 52	47.2 mg	Standard Deviation 75.46
Placebo	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 24	11.1 mg	Standard Deviation 33.33
Placebo	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 32	11.1 mg	Standard Deviation 33.33
Placebo	Change From Baseline in Dosage of Carbidopa/Levodopa	Week 42	36.1 mg	Standard Deviation 54.65

Secondary

Change From Baseline in MDS-UPDRS Part I.

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests Nonmotor experiences of daily living. Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in MDS-UPDRS Part I.	Week 16	-2.53 score on a scale (52 points total)	Standard Deviation 3.8
HB-adMSCs	Change From Baseline in MDS-UPDRS Part I.	Baseline Value	8.73 score on a scale (52 points total)	Standard Deviation 5.95
HB-adMSCs	Change From Baseline in MDS-UPDRS Part I.	Week 4	-1.47 score on a scale (52 points total)	Standard Deviation 2.5
HB-adMSCs	Change From Baseline in MDS-UPDRS Part I.	Week 8	-1.67 score on a scale (52 points total)	Standard Deviation 3.02
HB-adMSCs	Change From Baseline in MDS-UPDRS Part I.	Week 24	-1.40 score on a scale (52 points total)	Standard Deviation 3.94
HB-adMSCs	Change From Baseline in MDS-UPDRS Part I.	Week 32	-2.07 score on a scale (52 points total)	Standard Deviation 4.11
HB-adMSCs	Change From Baseline in MDS-UPDRS Part I.	Week 42	-0.87 score on a scale (52 points total)	Standard Deviation 4.26
HB-adMSCs	Change From Baseline in MDS-UPDRS Part I.	Week 52	-0.47 score on a scale (52 points total)	Standard Deviation 4.27
Placebo	Change From Baseline in MDS-UPDRS Part I.	Week 52	0.78 score on a scale (52 points total)	Standard Deviation 4.15
Placebo	Change From Baseline in MDS-UPDRS Part I.	Week 24	0.22 score on a scale (52 points total)	Standard Deviation 3.11
Placebo	Change From Baseline in MDS-UPDRS Part I.	Baseline Value	6.78 score on a scale (52 points total)	Standard Deviation 4.94
Placebo	Change From Baseline in MDS-UPDRS Part I.	Week 42	1.56 score on a scale (52 points total)	Standard Deviation 3.75
Placebo	Change From Baseline in MDS-UPDRS Part I.	Week 4	0.33 score on a scale (52 points total)	Standard Deviation 2.83
Placebo	Change From Baseline in MDS-UPDRS Part I.	Week 32	-0.33 score on a scale (52 points total)	Standard Deviation 3.67
Placebo	Change From Baseline in MDS-UPDRS Part I.	Week 8	-0.33 score on a scale (52 points total)	Standard Deviation 2.96
Placebo	Change From Baseline in MDS-UPDRS Part I.	Week 16	0.33 score on a scale (52 points total)	Standard Deviation 2.92

Secondary

Change From Baseline in MDS-UPDRS Part III.

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part III tests Motor examination. Motor Examination includes speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage. There are 18 items included in Part III. Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in MDS-UPDRS Part III.	Baseline Value	26.27 score on a scale (132 points total)	Standard Deviation 12.76
HB-adMSCs	Change From Baseline in MDS-UPDRS Part III.	Week 4	-5.33 score on a scale (132 points total)	Standard Deviation 8.72
HB-adMSCs	Change From Baseline in MDS-UPDRS Part III.	Week 8	-8.33 score on a scale (132 points total)	Standard Deviation 12.73
HB-adMSCs	Change From Baseline in MDS-UPDRS Part III.	Week 16	-8.13 score on a scale (132 points total)	Standard Deviation 13.52
HB-adMSCs	Change From Baseline in MDS-UPDRS Part III.	Week 24	-10.07 score on a scale (132 points total)	Standard Deviation 16.5
HB-adMSCs	Change From Baseline in MDS-UPDRS Part III.	Week 32	-11.27 score on a scale (132 points total)	Standard Deviation 13.82
HB-adMSCs	Change From Baseline in MDS-UPDRS Part III.	Week 42	-8.47 score on a scale (132 points total)	Standard Deviation 15.25
HB-adMSCs	Change From Baseline in MDS-UPDRS Part III.	Week 52	-9.07 score on a scale (132 points total)	Standard Deviation 14.23
Placebo	Change From Baseline in MDS-UPDRS Part III.	Week 52	-4.11 score on a scale (132 points total)	Standard Deviation 6.31
Placebo	Change From Baseline in MDS-UPDRS Part III.	Baseline Value	20.56 score on a scale (132 points total)	Standard Deviation 8.35
Placebo	Change From Baseline in MDS-UPDRS Part III.	Week 24	-2.78 score on a scale (132 points total)	Standard Deviation 12.25
Placebo	Change From Baseline in MDS-UPDRS Part III.	Week 4	-0.33 score on a scale (132 points total)	Standard Deviation 10.74
Placebo	Change From Baseline in MDS-UPDRS Part III.	Week 42	-3.56 score on a scale (132 points total)	Standard Deviation 11.28
Placebo	Change From Baseline in MDS-UPDRS Part III.	Week 8	-1.78 score on a scale (132 points total)	Standard Deviation 9.85
Placebo	Change From Baseline in MDS-UPDRS Part III.	Week 32	-4.33 score on a scale (132 points total)	Standard Deviation 8.93
Placebo	Change From Baseline in MDS-UPDRS Part III.	Week 16	-0.22 score on a scale (132 points total)	Standard Deviation 11.63

Secondary

Change From Baseline in MDS-UPDRS Part IV.

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part IV tests Motor Complications, including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in MDS-UPDRS Part IV.	Baseline Value	2.67 score on a scale (24 points total)	Standard Deviation 3.77
HB-adMSCs	Change From Baseline in MDS-UPDRS Part IV.	Week 4	-0.67 score on a scale (24 points total)	Standard Deviation 2.19
HB-adMSCs	Change From Baseline in MDS-UPDRS Part IV.	Week 8	-0.87 score on a scale (24 points total)	Standard Deviation 1.51
HB-adMSCs	Change From Baseline in MDS-UPDRS Part IV.	Week 16	-1.00 score on a scale (24 points total)	Standard Deviation 1.93
HB-adMSCs	Change From Baseline in MDS-UPDRS Part IV.	Week 24	-1.87 score on a scale (24 points total)	Standard Deviation 2.88
HB-adMSCs	Change From Baseline in MDS-UPDRS Part IV.	Week 32	-2.20 score on a scale (24 points total)	Standard Deviation 3.28
HB-adMSCs	Change From Baseline in MDS-UPDRS Part IV.	Week 42	-0.80 score on a scale (24 points total)	Standard Deviation 2.01
HB-adMSCs	Change From Baseline in MDS-UPDRS Part IV.	Week 52	-1.07 score on a scale (24 points total)	Standard Deviation 3.1
Placebo	Change From Baseline in MDS-UPDRS Part IV.	Week 52	-1.67 score on a scale (24 points total)	Standard Deviation 1.66
Placebo	Change From Baseline in MDS-UPDRS Part IV.	Baseline Value	3.56 score on a scale (24 points total)	Standard Deviation 2.3
Placebo	Change From Baseline in MDS-UPDRS Part IV.	Week 24	0.00 score on a scale (24 points total)	Standard Deviation 2
Placebo	Change From Baseline in MDS-UPDRS Part IV.	Week 4	-0.33 score on a scale (24 points total)	Standard Deviation 1.94
Placebo	Change From Baseline in MDS-UPDRS Part IV.	Week 42	-1.11 score on a scale (24 points total)	Standard Deviation 1.83
Placebo	Change From Baseline in MDS-UPDRS Part IV.	Week 8	-0.44 score on a scale (24 points total)	Standard Deviation 2.46
Placebo	Change From Baseline in MDS-UPDRS Part IV.	Week 32	-0.67 score on a scale (24 points total)	Standard Deviation 2.45
Placebo	Change From Baseline in MDS-UPDRS Part IV.	Week 16	-1.00 score on a scale (24 points total)	Standard Deviation 1.94

Secondary

Change From Baseline in Neuro-QOL. - Cognition

Cognition Function- Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Cognition Function short form has 8 questions regarding the cognition function levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Cognition	Baseline Value	33.47 score on a scale (40 points total)	Standard Deviation 6.21
HB-adMSCs	Change From Baseline in Neuro-QOL. - Cognition	Week 4	2.53 score on a scale (40 points total)	Standard Deviation 3.29
HB-adMSCs	Change From Baseline in Neuro-QOL. - Cognition	Week 8	1.33 score on a scale (40 points total)	Standard Deviation 3.74
HB-adMSCs	Change From Baseline in Neuro-QOL. - Cognition	Week 16	2.80 score on a scale (40 points total)	Standard Deviation 5.05
HB-adMSCs	Change From Baseline in Neuro-QOL. - Cognition	Week 24	2.87 score on a scale (40 points total)	Standard Deviation 4.98
HB-adMSCs	Change From Baseline in Neuro-QOL. - Cognition	Week 32	0.73 score on a scale (40 points total)	Standard Deviation 7.46
HB-adMSCs	Change From Baseline in Neuro-QOL. - Cognition	Week 42	0.87 score on a scale (40 points total)	Standard Deviation 5.91
HB-adMSCs	Change From Baseline in Neuro-QOL. - Cognition	Week 52	0.47 score on a scale (40 points total)	Standard Deviation 7.12
Placebo	Change From Baseline in Neuro-QOL. - Cognition	Week 52	1.56 score on a scale (40 points total)	Standard Deviation 4.36
Placebo	Change From Baseline in Neuro-QOL. - Cognition	Baseline Value	33.67 score on a scale (40 points total)	Standard Deviation 5.68
Placebo	Change From Baseline in Neuro-QOL. - Cognition	Week 24	2.00 score on a scale (40 points total)	Standard Deviation 3.04
Placebo	Change From Baseline in Neuro-QOL. - Cognition	Week 4	1.44 score on a scale (40 points total)	Standard Deviation 2.55
Placebo	Change From Baseline in Neuro-QOL. - Cognition	Week 42	2.44 score on a scale (40 points total)	Standard Deviation 4.33
Placebo	Change From Baseline in Neuro-QOL. - Cognition	Week 8	0.89 score on a scale (40 points total)	Standard Deviation 2.89
Placebo	Change From Baseline in Neuro-QOL. - Cognition	Week 32	2.44 score on a scale (40 points total)	Standard Deviation 3.88
Placebo	Change From Baseline in Neuro-QOL. - Cognition	Week 16	1.00 score on a scale (40 points total)	Standard Deviation 2.18

Secondary

Change From Baseline in Neuro-QOL. - Communication

Communication - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The communication short form has 5 questions regarding communicative abilities of the patient, and each question ranges from 0 points to 5 points (making the total 25 points). A higher score represents a better outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Communication	Baseline Value	22.87 score on a scale (25 points total)	Standard Deviation 2.83
HB-adMSCs	Change From Baseline in Neuro-QOL. - Communication	Week 4	0.40 score on a scale (25 points total)	Standard Deviation 0.83
HB-adMSCs	Change From Baseline in Neuro-QOL. - Communication	Week 8	0.53 score on a scale (25 points total)	Standard Deviation 1.92
HB-adMSCs	Change From Baseline in Neuro-QOL. - Communication	Week 16	0.67 score on a scale (25 points total)	Standard Deviation 1.45
HB-adMSCs	Change From Baseline in Neuro-QOL. - Communication	Week 24	0.00 score on a scale (25 points total)	Standard Deviation 0.85
HB-adMSCs	Change From Baseline in Neuro-QOL. - Communication	Week 32	0.27 score on a scale (25 points total)	Standard Deviation 1.22
HB-adMSCs	Change From Baseline in Neuro-QOL. - Communication	Week 42	0.00 score on a scale (25 points total)	Standard Deviation 0.76
HB-adMSCs	Change From Baseline in Neuro-QOL. - Communication	Week 52	-0.60 score on a scale (25 points total)	Standard Deviation 2.67
Placebo	Change From Baseline in Neuro-QOL. - Communication	Week 52	1.00 score on a scale (25 points total)	Standard Deviation 4.61
Placebo	Change From Baseline in Neuro-QOL. - Communication	Baseline Value	21.78 score on a scale (25 points total)	Standard Deviation 4.55
Placebo	Change From Baseline in Neuro-QOL. - Communication	Week 24	1.89 score on a scale (25 points total)	Standard Deviation 4.31
Placebo	Change From Baseline in Neuro-QOL. - Communication	Week 4	2.00 score on a scale (25 points total)	Standard Deviation 4.66
Placebo	Change From Baseline in Neuro-QOL. - Communication	Week 42	1.78 score on a scale (25 points total)	Standard Deviation 4.68
Placebo	Change From Baseline in Neuro-QOL. - Communication	Week 8	1.33 score on a scale (25 points total)	Standard Deviation 2.92
Placebo	Change From Baseline in Neuro-QOL. - Communication	Week 32	1.89 score on a scale (25 points total)	Standard Deviation 4.59
Placebo	Change From Baseline in Neuro-QOL. - Communication	Week 16	1.56 score on a scale (25 points total)	Standard Deviation 4.69

Secondary

Change From Baseline in Neuro-QOL. - Depression

Depression - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Depression short form has 8 questions regarding the depression level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Depression	Baseline Value	12.40 score on a scale (40 points total)	Standard Deviation 4.81
HB-adMSCs	Change From Baseline in Neuro-QOL. - Depression	Week 24	-1.00 score on a scale (40 points total)	Standard Deviation 5.44
HB-adMSCs	Change From Baseline in Neuro-QOL. - Depression	Week 8	-2.00 score on a scale (40 points total)	Standard Deviation 3.44
HB-adMSCs	Change From Baseline in Neuro-QOL. - Depression	Week 32	-1.47 score on a scale (40 points total)	Standard Deviation 3.91
HB-adMSCs	Change From Baseline in Neuro-QOL. - Depression	Week 4	-2.27 score on a scale (40 points total)	Standard Deviation 3.39
HB-adMSCs	Change From Baseline in Neuro-QOL. - Depression	Week 42	-1.80 score on a scale (40 points total)	Standard Deviation 4.97
HB-adMSCs	Change From Baseline in Neuro-QOL. - Depression	Week 16	-2.60 score on a scale (40 points total)	Standard Deviation 3.36
HB-adMSCs	Change From Baseline in Neuro-QOL. - Depression	Week 52	-1.40 score on a scale (40 points total)	Standard Deviation 4.32
Placebo	Change From Baseline in Neuro-QOL. - Depression	Week 16	0.44 score on a scale (40 points total)	Standard Deviation 1.24
Placebo	Change From Baseline in Neuro-QOL. - Depression	Baseline Value	9.89 score on a scale (40 points total)	Standard Deviation 2.26
Placebo	Change From Baseline in Neuro-QOL. - Depression	Week 4	0.11 score on a scale (40 points total)	Standard Deviation 2.15
Placebo	Change From Baseline in Neuro-QOL. - Depression	Week 8	-0.11 score on a scale (40 points total)	Standard Deviation 3.26
Placebo	Change From Baseline in Neuro-QOL. - Depression	Week 52	1.11 score on a scale (40 points total)	Standard Deviation 2.98
Placebo	Change From Baseline in Neuro-QOL. - Depression	Week 24	0.00 score on a scale (40 points total)	Standard Deviation 1.32
Placebo	Change From Baseline in Neuro-QOL. - Depression	Week 32	1.56 score on a scale (40 points total)	Standard Deviation 3.97
Placebo	Change From Baseline in Neuro-QOL. - Depression	Week 42	0.11 score on a scale (40 points total)	Standard Deviation 1.96

Secondary

Change From Baseline in Neuro-QOL. - Dyscontrol

Emotional and Behavioral Dyscontrol - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Dyscontrol short form has 8 questions regarding the emotional and behavioral dyscontrol level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Dyscontrol	Baseline Value	13.47 score on a scale (40 points total)	Standard Deviation 5.36
HB-adMSCs	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 4	-0.33 score on a scale (40 points total)	Standard Deviation 3.56
HB-adMSCs	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 8	-1.07 score on a scale (40 points total)	Standard Deviation 1.87
HB-adMSCs	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 16	-1.67 score on a scale (40 points total)	Standard Deviation 3.52
HB-adMSCs	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 24	-1.07 score on a scale (40 points total)	Standard Deviation 2.99
HB-adMSCs	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 32	0.20 score on a scale (40 points total)	Standard Deviation 4.35
HB-adMSCs	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 42	-0.73 score on a scale (40 points total)	Standard Deviation 4.01
HB-adMSCs	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 52	-0.93 score on a scale (40 points total)	Standard Deviation 3.17
Placebo	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 52	-0.78 score on a scale (40 points total)	Standard Deviation 2.59
Placebo	Change From Baseline in Neuro-QOL. - Dyscontrol	Baseline Value	10.89 score on a scale (40 points total)	Standard Deviation 3.37
Placebo	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 24	-1.11 score on a scale (40 points total)	Standard Deviation 2.2
Placebo	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 4	-0.11 score on a scale (40 points total)	Standard Deviation 2.47
Placebo	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 42	-0.78 score on a scale (40 points total)	Standard Deviation 2.64
Placebo	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 8	-0.67 score on a scale (40 points total)	Standard Deviation 2.55
Placebo	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 32	-0.78 score on a scale (40 points total)	Standard Deviation 2.86
Placebo	Change From Baseline in Neuro-QOL. - Dyscontrol	Week 16	0.22 score on a scale (40 points total)	Standard Deviation 3.7

Secondary

Change From Baseline in Neuro-QOL. - Fine Motor

Upper Extremity Function (Fine Motor, ADL) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Upper Extremity Function (Fine Motor, ADL) short form has 8 questions regarding the fine motor levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Fine Motor	Baseline Value	36.07 score on a scale (40 points total)	Standard Deviation 4.37
HB-adMSCs	Change From Baseline in Neuro-QOL. - Fine Motor	Week 4	0.80 score on a scale (40 points total)	Standard Deviation 2.11
HB-adMSCs	Change From Baseline in Neuro-QOL. - Fine Motor	Week 8	0.47 score on a scale (40 points total)	Standard Deviation 1.68
HB-adMSCs	Change From Baseline in Neuro-QOL. - Fine Motor	Week 16	1.93 score on a scale (40 points total)	Standard Deviation 3.1
HB-adMSCs	Change From Baseline in Neuro-QOL. - Fine Motor	Week 24	0.87 score on a scale (40 points total)	Standard Deviation 2.33
HB-adMSCs	Change From Baseline in Neuro-QOL. - Fine Motor	Week 32	0.40 score on a scale (40 points total)	Standard Deviation 2.56
HB-adMSCs	Change From Baseline in Neuro-QOL. - Fine Motor	Week 42	-0.60 score on a scale (40 points total)	Standard Deviation 4.14
HB-adMSCs	Change From Baseline in Neuro-QOL. - Fine Motor	Week 52	-0.53 score on a scale (40 points total)	Standard Deviation 3.09
Placebo	Change From Baseline in Neuro-QOL. - Fine Motor	Week 52	0.67 score on a scale (40 points total)	Standard Deviation 1.5
Placebo	Change From Baseline in Neuro-QOL. - Fine Motor	Baseline Value	37.33 score on a scale (40 points total)	Standard Deviation 2.65
Placebo	Change From Baseline in Neuro-QOL. - Fine Motor	Week 24	1.22 score on a scale (40 points total)	Standard Deviation 1.48
Placebo	Change From Baseline in Neuro-QOL. - Fine Motor	Week 4	1.67 score on a scale (40 points total)	Standard Deviation 2.5
Placebo	Change From Baseline in Neuro-QOL. - Fine Motor	Week 42	0.44 score on a scale (40 points total)	Standard Deviation 1.42
Placebo	Change From Baseline in Neuro-QOL. - Fine Motor	Week 8	1.11 score on a scale (40 points total)	Standard Deviation 1.69
Placebo	Change From Baseline in Neuro-QOL. - Fine Motor	Week 32	0.56 score on a scale (40 points total)	Standard Deviation 1.42
Placebo	Change From Baseline in Neuro-QOL. - Fine Motor	Week 16	0.78 score on a scale (40 points total)	Standard Deviation 2.17

Secondary

Change From Baseline in Neuro-QOL. - Mobility

Lower Extremity Function (Mobility) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Mobility short form has 8 questions regarding the Lower Extremity Function (Mobility) level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Mobility	Baseline Value	37.00 score on a scale (40 points total)	Standard Deviation 3.09
HB-adMSCs	Change From Baseline in Neuro-QOL. - Mobility	Week 4	-0.53 score on a scale (40 points total)	Standard Deviation 1.88
HB-adMSCs	Change From Baseline in Neuro-QOL. - Mobility	Week 8	-0.33 score on a scale (40 points total)	Standard Deviation 3.46
HB-adMSCs	Change From Baseline in Neuro-QOL. - Mobility	Week 16	0.53 score on a scale (40 points total)	Standard Deviation 3.5
HB-adMSCs	Change From Baseline in Neuro-QOL. - Mobility	Week 24	0.13 score on a scale (40 points total)	Standard Deviation 3.14
HB-adMSCs	Change From Baseline in Neuro-QOL. - Mobility	Week 32	-0.07 score on a scale (40 points total)	Standard Deviation 2.79
HB-adMSCs	Change From Baseline in Neuro-QOL. - Mobility	Week 42	-0.53 score on a scale (40 points total)	Standard Deviation 2.88
HB-adMSCs	Change From Baseline in Neuro-QOL. - Mobility	Week 52	-1.67 score on a scale (40 points total)	Standard Deviation 5
Placebo	Change From Baseline in Neuro-QOL. - Mobility	Week 52	-0.67 score on a scale (40 points total)	Standard Deviation 2.96
Placebo	Change From Baseline in Neuro-QOL. - Mobility	Baseline Value	38.22 score on a scale (40 points total)	Standard Deviation 3.11
Placebo	Change From Baseline in Neuro-QOL. - Mobility	Week 24	0.11 score on a scale (40 points total)	Standard Deviation 3.98
Placebo	Change From Baseline in Neuro-QOL. - Mobility	Week 4	0.33 score on a scale (40 points total)	Standard Deviation 3.08
Placebo	Change From Baseline in Neuro-QOL. - Mobility	Week 42	-0.33 score on a scale (40 points total)	Standard Deviation 3.43
Placebo	Change From Baseline in Neuro-QOL. - Mobility	Week 8	0.22 score on a scale (40 points total)	Standard Deviation 2.68
Placebo	Change From Baseline in Neuro-QOL. - Mobility	Week 32	-0.33 score on a scale (40 points total)	Standard Deviation 4.5
Placebo	Change From Baseline in Neuro-QOL. - Mobility	Week 16	1.22 score on a scale (40 points total)	Standard Deviation 2.91

Secondary

Change From Baseline in Neuro-QOL. - Sleep

Sleep Disturbance - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Sleep disturbance short form has 8 questions regarding the sleep level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Sleep	Week 4	-2.33 score on a scale (40 points total)	Standard Deviation 4.45
HB-adMSCs	Change From Baseline in Neuro-QOL. - Sleep	Week 24	-3.27 score on a scale (40 points total)	Standard Deviation 5.5
HB-adMSCs	Change From Baseline in Neuro-QOL. - Sleep	Week 8	-1.73 score on a scale (40 points total)	Standard Deviation 5.27
HB-adMSCs	Change From Baseline in Neuro-QOL. - Sleep	Week 32	-3.00 score on a scale (40 points total)	Standard Deviation 5.73
HB-adMSCs	Change From Baseline in Neuro-QOL. - Sleep	Week 16	-2.60 score on a scale (40 points total)	Standard Deviation 5.74
HB-adMSCs	Change From Baseline in Neuro-QOL. - Sleep	Week 42	-1.93 score on a scale (40 points total)	Standard Deviation 6.12
HB-adMSCs	Change From Baseline in Neuro-QOL. - Sleep	Week 52	-1.93 score on a scale (40 points total)	Standard Deviation 5.04
HB-adMSCs	Change From Baseline in Neuro-QOL. - Sleep	Baseline Value	16.20 score on a scale (40 points total)	Standard Deviation 6.32
Placebo	Change From Baseline in Neuro-QOL. - Sleep	Week 52	-1.67 score on a scale (40 points total)	Standard Deviation 5.41
Placebo	Change From Baseline in Neuro-QOL. - Sleep	Baseline Value	14.33 score on a scale (40 points total)	Standard Deviation 4.74
Placebo	Change From Baseline in Neuro-QOL. - Sleep	Week 4	-1.89 score on a scale (40 points total)	Standard Deviation 2.98
Placebo	Change From Baseline in Neuro-QOL. - Sleep	Week 42	-1.22 score on a scale (40 points total)	Standard Deviation 5.38
Placebo	Change From Baseline in Neuro-QOL. - Sleep	Week 8	-1.89 score on a scale (40 points total)	Standard Deviation 3.55
Placebo	Change From Baseline in Neuro-QOL. - Sleep	Week 16	-0.11 score on a scale (40 points total)	Standard Deviation 3.86
Placebo	Change From Baseline in Neuro-QOL. - Sleep	Week 24	-1.22 score on a scale (40 points total)	Standard Deviation 3.87
Placebo	Change From Baseline in Neuro-QOL. - Sleep	Week 32	-2.33 score on a scale (40 points total)	Standard Deviation 4.95

Secondary

Change From Baseline in Neuro-QOL. - Social Roles

Satisfaction with Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Satisfaction with Social Roles and Activities short form has 8 questions regarding the satisfaction levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles	Baseline Value	30.47 score on a scale (40 points total)	Standard Deviation 5.68
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles	Week 4	3.27 score on a scale (40 points total)	Standard Deviation 7.39
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles	Week 8	2.87 score on a scale (40 points total)	Standard Deviation 6.57
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles	Week 16	3.87 score on a scale (40 points total)	Standard Deviation 8.74
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles	Week 24	2.27 score on a scale (40 points total)	Standard Deviation 6.31
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles	Week 32	1.53 score on a scale (40 points total)	Standard Deviation 8.42
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles	Week 42	1.53 score on a scale (40 points total)	Standard Deviation 9.03
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles	Week 52	1.20 score on a scale (40 points total)	Standard Deviation 6.65
Placebo	Change From Baseline in Neuro-QOL. - Social Roles	Week 52	0.44 score on a scale (40 points total)	Standard Deviation 3.64
Placebo	Change From Baseline in Neuro-QOL. - Social Roles	Baseline Value	33.78 score on a scale (40 points total)	Standard Deviation 5.31
Placebo	Change From Baseline in Neuro-QOL. - Social Roles	Week 24	-1.67 score on a scale (40 points total)	Standard Deviation 7.81
Placebo	Change From Baseline in Neuro-QOL. - Social Roles	Week 4	1.22 score on a scale (40 points total)	Standard Deviation 4.71
Placebo	Change From Baseline in Neuro-QOL. - Social Roles	Week 42	1.67 score on a scale (40 points total)	Standard Deviation 4.66
Placebo	Change From Baseline in Neuro-QOL. - Social Roles	Week 8	1.89 score on a scale (40 points total)	Standard Deviation 4.99
Placebo	Change From Baseline in Neuro-QOL. - Social Roles	Week 32	1.56 score on a scale (40 points total)	Standard Deviation 3.68
Placebo	Change From Baseline in Neuro-QOL. - Social Roles	Week 16	-0.44 score on a scale (40 points total)	Standard Deviation 8.16

Secondary

Change From Baseline in Neuro-QOL. - Social Roles and Activities

Ability to Participate in Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Ability to Participate in Social Roles and Activities short form has 8 questions regarding social abilities of the patient (familial and friend relationships), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 24	-2.27 score on a scale (40 points total)	Standard Deviation 8.03
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 8	0.47 score on a scale (40 points total)	Standard Deviation 3.04
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 32	-0.40 score on a scale (40 points total)	Standard Deviation 2.69
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Baseline Value	36.00 score on a scale (40 points total)	Standard Deviation 4.68
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 42	0.13 score on a scale (40 points total)	Standard Deviation 4.7
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 16	1.73 score on a scale (40 points total)	Standard Deviation 4.13
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 52	-1.93 score on a scale (40 points total)	Standard Deviation 7.16
HB-adMSCs	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 4	0.93 score on a scale (40 points total)	Standard Deviation 2.62
Placebo	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 52	0.33 score on a scale (40 points total)	Standard Deviation 7.09
Placebo	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Baseline Value	35.22 score on a scale (40 points total)	Standard Deviation 5.14
Placebo	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 8	1.22 score on a scale (40 points total)	Standard Deviation 5.38
Placebo	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 16	0.56 score on a scale (40 points total)	Standard Deviation 6.84
Placebo	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 24	2.33 score on a scale (40 points total)	Standard Deviation 6.26
Placebo	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 32	0.78 score on a scale (40 points total)	Standard Deviation 5.12
Placebo	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 42	0.56 score on a scale (40 points total)	Standard Deviation 6.44
Placebo	Change From Baseline in Neuro-QOL. - Social Roles and Activities	Week 4	1.00 score on a scale (40 points total)	Standard Deviation 5.15

Secondary

Change From Baseline in Neuro-QOL. - Stigma

Stigma-Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Stigma short form has 8 questions regarding the stigma levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Stigma	Baseline Value	12.33 score on a scale (40 points total)	Standard Deviation 4.48
HB-adMSCs	Change From Baseline in Neuro-QOL. - Stigma	Week 4	-1.20 score on a scale (40 points total)	Standard Deviation 3.71
HB-adMSCs	Change From Baseline in Neuro-QOL. - Stigma	Week 8	-0.67 score on a scale (40 points total)	Standard Deviation 3.75
HB-adMSCs	Change From Baseline in Neuro-QOL. - Stigma	Week 16	-1.27 score on a scale (40 points total)	Standard Deviation 3.49
HB-adMSCs	Change From Baseline in Neuro-QOL. - Stigma	Week 24	-1.40 score on a scale (40 points total)	Standard Deviation 3.52
HB-adMSCs	Change From Baseline in Neuro-QOL. - Stigma	Week 32	-0.67 score on a scale (40 points total)	Standard Deviation 3.75
HB-adMSCs	Change From Baseline in Neuro-QOL. - Stigma	Week 42	-1.87 score on a scale (40 points total)	Standard Deviation 3.89
HB-adMSCs	Change From Baseline in Neuro-QOL. - Stigma	Week 52	-0.93 score on a scale (40 points total)	Standard Deviation 3.84
Placebo	Change From Baseline in Neuro-QOL. - Stigma	Week 52	-1.89 score on a scale (40 points total)	Standard Deviation 2.47
Placebo	Change From Baseline in Neuro-QOL. - Stigma	Baseline Value	12.00 score on a scale (40 points total)	Standard Deviation 3.87
Placebo	Change From Baseline in Neuro-QOL. - Stigma	Week 24	-1.22 score on a scale (40 points total)	Standard Deviation 2.49
Placebo	Change From Baseline in Neuro-QOL. - Stigma	Week 4	-1.22 score on a scale (40 points total)	Standard Deviation 2.82
Placebo	Change From Baseline in Neuro-QOL. - Stigma	Week 42	-0.56 score on a scale (40 points total)	Standard Deviation 1.81
Placebo	Change From Baseline in Neuro-QOL. - Stigma	Week 8	-1.44 score on a scale (40 points total)	Standard Deviation 2.46
Placebo	Change From Baseline in Neuro-QOL. - Stigma	Week 32	-0.89 score on a scale (40 points total)	Standard Deviation 1.36
Placebo	Change From Baseline in Neuro-QOL. - Stigma	Week 16	-0.33 score on a scale (40 points total)	Standard Deviation 2.92

Secondary

Change From Baseline in Neuro-QOL. - Well-Being

Positive Affect and Well-Being - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Positive Affect and Well-Being short form has 8 questions regarding the well-being level of the patient, and each question ranges from 0 points to 5 points (making the total 45 points). A higher score represents a better outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Neuro-QOL. - Well-Being	Baseline Value	36.87 score on a scale (45 points total)	Standard Deviation 5.22
HB-adMSCs	Change From Baseline in Neuro-QOL. - Well-Being	Week 4	3.00 score on a scale (45 points total)	Standard Deviation 3.23
HB-adMSCs	Change From Baseline in Neuro-QOL. - Well-Being	Week 8	2.73 score on a scale (45 points total)	Standard Deviation 2.94
HB-adMSCs	Change From Baseline in Neuro-QOL. - Well-Being	Week 16	4.33 score on a scale (45 points total)	Standard Deviation 5.05
HB-adMSCs	Change From Baseline in Neuro-QOL. - Well-Being	Week 24	0.80 score on a scale (45 points total)	Standard Deviation 4.63
HB-adMSCs	Change From Baseline in Neuro-QOL. - Well-Being	Week 32	1.67 score on a scale (45 points total)	Standard Deviation 3.89
HB-adMSCs	Change From Baseline in Neuro-QOL. - Well-Being	Week 42	1.67 score on a scale (45 points total)	Standard Deviation 5.6
HB-adMSCs	Change From Baseline in Neuro-QOL. - Well-Being	Week 52	2.67 score on a scale (45 points total)	Standard Deviation 4.42
Placebo	Change From Baseline in Neuro-QOL. - Well-Being	Week 52	-1.78 score on a scale (45 points total)	Standard Deviation 8.97
Placebo	Change From Baseline in Neuro-QOL. - Well-Being	Baseline Value	39.00 score on a scale (45 points total)	Standard Deviation 4.39
Placebo	Change From Baseline in Neuro-QOL. - Well-Being	Week 24	1.00 score on a scale (45 points total)	Standard Deviation 5.57
Placebo	Change From Baseline in Neuro-QOL. - Well-Being	Week 4	-1.22 score on a scale (45 points total)	Standard Deviation 5.21
Placebo	Change From Baseline in Neuro-QOL. - Well-Being	Week 42	0.00 score on a scale (45 points total)	Standard Deviation 4.5
Placebo	Change From Baseline in Neuro-QOL. - Well-Being	Week 8	0.33 score on a scale (45 points total)	Standard Deviation 5.05
Placebo	Change From Baseline in Neuro-QOL. - Well-Being	Week 32	-1.89 score on a scale (45 points total)	Standard Deviation 5.53
Placebo	Change From Baseline in Neuro-QOL. - Well-Being	Week 16	-0.44 score on a scale (45 points total)	Standard Deviation 4.33

Secondary

Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).

The Parkinson's disease fatigue scale (PFS-16) is an 16 question assessment that measures the level of fatigue in patients diagnosed with Parkinson's disease. Each question has 5 answer choices established as strongly disagree, disagree, do not agree or disagree, agree, and strongly agree, which are scored as 1 to 5, respectively, making the total score from 16 to 80 points. Higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Baseline Value	37.20 score on a scale (80 points total)	Standard Deviation 18.18
HB-adMSCs	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 4	-0.73 score on a scale (80 points total)	Standard Deviation 10.59
HB-adMSCs	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 8	0.20 score on a scale (80 points total)	Standard Deviation 5.23
HB-adMSCs	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 16	-3.40 score on a scale (80 points total)	Standard Deviation 7.7
HB-adMSCs	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 24	-2.33 score on a scale (80 points total)	Standard Deviation 10.38
HB-adMSCs	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 32	-3.00 score on a scale (80 points total)	Standard Deviation 12.58
HB-adMSCs	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 42	-1.00 score on a scale (80 points total)	Standard Deviation 11.43
HB-adMSCs	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 52	2.67 score on a scale (80 points total)	Standard Deviation 5.29
Placebo	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 52	-2.89 score on a scale (80 points total)	Standard Deviation 11.77
Placebo	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Baseline Value	34.11 score on a scale (80 points total)	Standard Deviation 15.21
Placebo	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 24	-4.11 score on a scale (80 points total)	Standard Deviation 8.45
Placebo	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 4	-8.33 score on a scale (80 points total)	Standard Deviation 9.46
Placebo	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 42	-4.11 score on a scale (80 points total)	Standard Deviation 8.34
Placebo	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 8	-4.33 score on a scale (80 points total)	Standard Deviation 12.25
Placebo	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 32	-3.56 score on a scale (80 points total)	Standard Deviation 12.08
Placebo	Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).	Week 16	-2.33 score on a scale (80 points total)	Standard Deviation 9.79

Secondary

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).

The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100. The final reported score (summary index) is calculated by averaging the 8 scaled scores. Higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Baseline Value	28.13 score on a scale (100 points total)	Standard Deviation 20.2
HB-adMSCs	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 24	-7.07 score on a scale (100 points total)	Standard Deviation 13.25
HB-adMSCs	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 8	-4.67 score on a scale (100 points total)	Standard Deviation 14.36
HB-adMSCs	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 32	-6.93 score on a scale (100 points total)	Standard Deviation 12.48
HB-adMSCs	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 42	-4.93 score on a scale (100 points total)	Standard Deviation 13.41
HB-adMSCs	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 4	-4.87 score on a scale (100 points total)	Standard Deviation 10.03
HB-adMSCs	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 52	-0.33 score on a scale (100 points total)	Standard Deviation 16.6
HB-adMSCs	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 16	-6.60 score on a scale (100 points total)	Standard Deviation 14.25
Placebo	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 52	0.33 score on a scale (100 points total)	Standard Deviation 12.31
Placebo	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Baseline Value	18.67 score on a scale (100 points total)	Standard Deviation 12.18
Placebo	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 4	-2.78 score on a scale (100 points total)	Standard Deviation 8.71
Placebo	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 8	-4.33 score on a scale (100 points total)	Standard Deviation 12.49
Placebo	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 16	-0.11 score on a scale (100 points total)	Standard Deviation 14.34
Placebo	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 24	0.11 score on a scale (100 points total)	Standard Deviation 14.38
Placebo	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 42	-2.33 score on a scale (100 points total)	Standard Deviation 12.76
Placebo	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).	Week 32	-2.67 score on a scale (100 points total)	Standard Deviation 9.75

Secondary

Change From Baseline in Total Visual Analog Scale

Visual Analog Scale for Pain and Muscle Spasm. The pain and muscle spasm VAS is a unidimensional measure of pain/ muscle spasm intensity, used to record patients' pain progression and muscle spasm progression, or compare pain and muscle spasm severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark summed with the distance (mm) on the 10-cm line between the no muscle spasm anchor and the patient's mark, providing a range of scores from 0-200. A higher score indicates greater pain/spasm intensity.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Total Visual Analog Scale	Baseline Value	35.93 score on a scale (200 points total)	Standard Deviation 37.75
HB-adMSCs	Change From Baseline in Total Visual Analog Scale	Week 4	-5.33 score on a scale (200 points total)	Standard Deviation 32.87
HB-adMSCs	Change From Baseline in Total Visual Analog Scale	Week 8	-8.27 score on a scale (200 points total)	Standard Deviation 10.92
HB-adMSCs	Change From Baseline in Total Visual Analog Scale	Week 16	-3.53 score on a scale (200 points total)	Standard Deviation 20.78
HB-adMSCs	Change From Baseline in Total Visual Analog Scale	Week 24	-11.0 score on a scale (200 points total)	Standard Deviation 37.63
HB-adMSCs	Change From Baseline in Total Visual Analog Scale	Week 32	-15.13 score on a scale (200 points total)	Standard Deviation 37.05
HB-adMSCs	Change From Baseline in Total Visual Analog Scale	Week 42	-7.80 score on a scale (200 points total)	Standard Deviation 31.93
HB-adMSCs	Change From Baseline in Total Visual Analog Scale	Week 52	-6.73 score on a scale (200 points total)	Standard Deviation 21.53
Placebo	Change From Baseline in Total Visual Analog Scale	Week 52	-10.00 score on a scale (200 points total)	Standard Deviation 16.41
Placebo	Change From Baseline in Total Visual Analog Scale	Baseline Value	19.89 score on a scale (200 points total)	Standard Deviation 21.8
Placebo	Change From Baseline in Total Visual Analog Scale	Week 24	6.78 score on a scale (200 points total)	Standard Deviation 29.85
Placebo	Change From Baseline in Total Visual Analog Scale	Week 4	2.89 score on a scale (200 points total)	Standard Deviation 16.8
Placebo	Change From Baseline in Total Visual Analog Scale	Week 42	9.89 score on a scale (200 points total)	Standard Deviation 22.65
Placebo	Change From Baseline in Total Visual Analog Scale	Week 8	-3.33 score on a scale (200 points total)	Standard Deviation 10.69
Placebo	Change From Baseline in Total Visual Analog Scale	Week 32	9.22 score on a scale (200 points total)	Standard Deviation 34.82
Placebo	Change From Baseline in Total Visual Analog Scale	Week 16	16.11 score on a scale (200 points total)	Standard Deviation 68.18

Secondary

Change From Baseline in Vital Signs. - Oxygen Saturation.

Changes in Oxygen Saturation.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Change From Baseline in Vital Signs. - Oxygen Saturation.	Baseline Value	97.8 percent of oxygen	Standard Deviation 1.01
HB-adMSCs	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 4	-0.2 percent of oxygen	Standard Deviation 2.14
HB-adMSCs	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 8	0.2 percent of oxygen	Standard Deviation 1.08
HB-adMSCs	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 16	0.1 percent of oxygen	Standard Deviation 0.88
HB-adMSCs	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 24	-0.5 percent of oxygen	Standard Deviation 0.83
HB-adMSCs	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 32	-0.3 percent of oxygen	Standard Deviation 0.82
HB-adMSCs	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 42	-0.6 percent of oxygen	Standard Deviation 1.18
HB-adMSCs	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 52	-0.7 percent of oxygen	Standard Deviation 1.5
Placebo	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 52	0.3 percent of oxygen	Standard Deviation 1
Placebo	Change From Baseline in Vital Signs. - Oxygen Saturation.	Baseline Value	97.6 percent of oxygen	Standard Deviation 1.74
Placebo	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 24	0.1 percent of oxygen	Standard Deviation 1.05
Placebo	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 4	-1.0 percent of oxygen	Standard Deviation 2.65
Placebo	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 42	0.0 percent of oxygen	Standard Deviation 1.41
Placebo	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 8	0.6 percent of oxygen	Standard Deviation 1.42
Placebo	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 32	0.3 percent of oxygen	Standard Deviation 1.73
Placebo	Change From Baseline in Vital Signs. - Oxygen Saturation.	Week 16	-0.2 percent of oxygen	Standard Deviation 1.72

Secondary

Changes From Baseline in Neuro-QOL. - Anxiety

Anxiety - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Anxiety short form has 8 questions regarding the anxiety level of the patient (inquiring about level of uneasiness and worry), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Anxiety	Baseline Value	17.87 score on a scale (40 points total)	Standard Deviation 6.51
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Anxiety	Week 4	-1.40 score on a scale (40 points total)	Standard Deviation 3.74
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Anxiety	Week 8	-2.40 score on a scale (40 points total)	Standard Deviation 2.35
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Anxiety	Week 16	-3.07 score on a scale (40 points total)	Standard Deviation 4.22
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Anxiety	Week 24	-2.33 score on a scale (40 points total)	Standard Deviation 5.45
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Anxiety	Week 32	-1.80 score on a scale (40 points total)	Standard Deviation 5.1
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Anxiety	Week 42	-2.07 score on a scale (40 points total)	Standard Deviation 5.68
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Anxiety	Week 52	-2.00 score on a scale (40 points total)	Standard Deviation 4.36
Placebo	Changes From Baseline in Neuro-QOL. - Anxiety	Week 52	-1.56 score on a scale (40 points total)	Standard Deviation 3.84
Placebo	Changes From Baseline in Neuro-QOL. - Anxiety	Baseline Value	14.11 score on a scale (40 points total)	Standard Deviation 4.11
Placebo	Changes From Baseline in Neuro-QOL. - Anxiety	Week 24	-1.67 score on a scale (40 points total)	Standard Deviation 3.57
Placebo	Changes From Baseline in Neuro-QOL. - Anxiety	Week 4	-1.00 score on a scale (40 points total)	Standard Deviation 2.6
Placebo	Changes From Baseline in Neuro-QOL. - Anxiety	Week 42	-2.00 score on a scale (40 points total)	Standard Deviation 4.06
Placebo	Changes From Baseline in Neuro-QOL. - Anxiety	Week 8	-1.44 score on a scale (40 points total)	Standard Deviation 2.92
Placebo	Changes From Baseline in Neuro-QOL. - Anxiety	Week 32	-1.44 score on a scale (40 points total)	Standard Deviation 4.5
Placebo	Changes From Baseline in Neuro-QOL. - Anxiety	Week 16	-0.22 score on a scale (40 points total)	Standard Deviation 4.38

Secondary

Changes From Baseline in Neuro-QOL. - Fatigue

Fatigue - Short Form Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The Fatigue short form has 8 questions regarding the Fatigue level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame: Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Fatigue	Baseline Value	16.67 score on a scale (40 points total)	Standard Deviation 7.9
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Fatigue	Week 4	-1.73 score on a scale (40 points total)	Standard Deviation 3.1
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Fatigue	Week 8	-1.67 score on a scale (40 points total)	Standard Deviation 3.46
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Fatigue	Week 16	-2.40 score on a scale (40 points total)	Standard Deviation 4.75
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Fatigue	Week 24	-1.13 score on a scale (40 points total)	Standard Deviation 6.24
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Fatigue	Week 32	-2.00 score on a scale (40 points total)	Standard Deviation 4.99
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Fatigue	Week 42	-0.93 score on a scale (40 points total)	Standard Deviation 6.09
HB-adMSCs	Changes From Baseline in Neuro-QOL. - Fatigue	Week 52	1.47 score on a scale (40 points total)	Standard Deviation 5.04
Placebo	Changes From Baseline in Neuro-QOL. - Fatigue	Week 52	0.67 score on a scale (40 points total)	Standard Deviation 5.89
Placebo	Changes From Baseline in Neuro-QOL. - Fatigue	Baseline Value	14.11 score on a scale (40 points total)	Standard Deviation 4.46
Placebo	Changes From Baseline in Neuro-QOL. - Fatigue	Week 24	0.33 score on a scale (40 points total)	Standard Deviation 4.82
Placebo	Changes From Baseline in Neuro-QOL. - Fatigue	Week 4	0.11 score on a scale (40 points total)	Standard Deviation 3.69
Placebo	Changes From Baseline in Neuro-QOL. - Fatigue	Week 42	-0.33 score on a scale (40 points total)	Standard Deviation 5.85
Placebo	Changes From Baseline in Neuro-QOL. - Fatigue	Week 8	-1.11 score on a scale (40 points total)	Standard Deviation 4.86
Placebo	Changes From Baseline in Neuro-QOL. - Fatigue	Week 32	0.11 score on a scale (40 points total)	Standard Deviation 7.17
Placebo	Changes From Baseline in Neuro-QOL. - Fatigue	Week 16	1.67 score on a scale (40 points total)	Standard Deviation 5.63

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026

Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in MDS-UPDRS Part II.

Laboratory Values. CBC (10^12 Cells/L)

Laboratory Values. CBC (10^9 Cells/L)

Laboratory Values. CBC (% Difference in Volume and Size of RBC)

Laboratory Values. CBC (fL)

Laboratory Values. CBC (g/dL)

Laboratory Values. CBC (% of Total Blood Cell Count)

Laboratory Values. CBC (% of WBC)

Laboratory Values. CBC (pg)

Laboratory Values. CMP (g/dL)

Laboratory Values. CMP (IU/L)

Laboratory Values. CMP (mg/dL)

Laboratory Values. CMP (mL/Min/1.73m^2)

Laboratory Values. CMP (mmol/L)

Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))

Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))

Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))

Laboratory Values. Coagulation Panel (Seconds)

Vital Signs. - Blood Pressure (mmHg)

Vital Signs. - Body Temperature (Celsius )

Vital Signs. - Heart Rate (Beats Per Minute)

Vital Signs. - Respiratory Rate (Breaths Per Minute)

Weight in kg.

Change From Baseline in Dosage of Carbidopa/Levodopa

Change From Baseline in MDS-UPDRS Part I.

Change From Baseline in MDS-UPDRS Part III.

Change From Baseline in MDS-UPDRS Part IV.

Change From Baseline in Neuro-QOL. - Cognition

Change From Baseline in Neuro-QOL. - Communication

Change From Baseline in Neuro-QOL. - Depression

Change From Baseline in Neuro-QOL. - Dyscontrol

Change From Baseline in Neuro-QOL. - Fine Motor

Change From Baseline in Neuro-QOL. - Mobility

Change From Baseline in Neuro-QOL. - Sleep

Change From Baseline in Neuro-QOL. - Social Roles

Change From Baseline in Neuro-QOL. - Social Roles and Activities

Change From Baseline in Neuro-QOL. - Stigma

Change From Baseline in Neuro-QOL. - Well-Being

Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).

Change From Baseline in Total Visual Analog Scale

Change From Baseline in Vital Signs. - Oxygen Saturation.

Changes From Baseline in Neuro-QOL. - Anxiety

Changes From Baseline in Neuro-QOL. - Fatigue