Autoimmune Diseases, Cardiovascular Disorders, Diabetes Complications, Integumentary Disease, Musculoskeletal Disorders, Neurodegenerative Disorders, Neurologic Disorders, Pulmonary Disorders, Sexual Dysfunction, Urologic Disorders, Viral Illness
Conditions
Keywords
stem cell therapy, umbilical cord stem cells, amniotic stem cells, stem cells, MSC, Mesenchymal Stem Cell, Medicinal Signaling Cell, Erectile Dysfunction, Heart Diseases, Mental Disorders, Neurocognitive Disorders, Neurodegenerative Diseases, Central Nervous System Diseases, Tauopathies, Brain Diseases, Dementia, Disease, Cardiomyopathies, Urologic Diseases, Peripheral Nervous System Diseases, Nervous System Diseases, Alzheimer Disease, Musculoskeletal Diseases, Cardiovascular Diseases, Immune System Diseases, Neuromuscular Diseases, Covid-19
Brief summary
This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.
Detailed description
This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions. This study investigates clinical outcomes of treatments for numerous indications including: Autoimmune, Cardiovascular, Diabetes, Integumentary, Neurologic / Neurodegenerative, Pulmonary, Orthopedic Diseases, Sexual Dysfunction, Urologic Disorders and Viral Illnesses. Our hypotheses posit that regenerative treatments are both safe and statistically beneficial for a range of conditions. Outcomes will be determined by multiple valid outcome instruments that measure general quality of life information along with condition-specific information.
Interventions
BIOLOGICALPrimePro™/ PrimeMSK™
Injection via condition specific route of administration.
Sponsors
HeartStem Institute
NuStem
Thomas Advanced Medical LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a multi-center, prospective, open label clinical trial. It will include 5000 patients suffering acute and chronic conditions under 10 different categories. Patients will undergo a single treatment with a biological tissue allograft and will be followed for 12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 and older * Ability to provide informed consent * Availability for follow up visits
Exclusion criteria
* Active or recent malignancy (within last 2 years) * Pregnancy or breast-feeding * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months. | Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. | Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function. |
| Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months. | Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. | General Health Outcome Instrument used to derive a simple psychometric score for health related quality of life which provides scores on various dimensions or items describing the systems. The score is derived by adding the unweighted response order of each question, with a lower score denoting a better quality of life. |
| Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months. | Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. | Upper Extremity Outcome Instrument |
| Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months. | Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. | Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction. |
| Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months. | Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. | COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status. |
| Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months. | Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. | Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia. |
| Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months. | Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. | Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function. |
| Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months. | Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months. | Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best) |
Countries
United States
Contacts
Primary ContactPaul C Bogaardt, PhD(c), MSc, MBA
Backup ContactKaren Mulholland Angelus
Outcome results
None listed