Traumatic Brain Injury
Conditions
Brief summary
The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of intracranial administration of SB623 cells on disability parameters and 2) to evaluate the safety and tolerability of intracranial administration of SB623 cells. Patients with stable, chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.
Detailed description
This study was a multicenter, randomized (3:1) double-blind, active and sham-surgery controlled study to evaluate the safety, tolerability, and efficacy of stereotactic intracranial injection of SB623 cells in patients with fixed motor deficits from TBI. The study was conducted at approximately 22 sites across the United States, Ukraine, and Japan. Two groups, Group 1 and Group 2, received investigational product SB623 and sham surgery, respectively, in a 3:1 randomization scheme. Group 1 was further randomized in a 1:1:1 ratio to receive either 2.5 million, 5 million, or 10 million SB623 cells. Randomization was performed via an interactive web response system (IWRS).
Interventions
BIOLOGICALSB623 cells
SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
PROCEDURESham Control
Sham Surgery
Sponsors
SanBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Documented history of TBI, with correlated MRI or CT * At least 12 months post-TBI * Focal cerebral injury able to be identified on MRI (+/- concomitant diffuse axonal injury) * Neurological motor deficit substantially due to focal cerebral injury observed on MRI * GOS-E score of 3-6 (i.e. moderate or severe disability) * Require Motricity Index 10-81 (UE Scale) and/or 10-78 (LE Scale) * Able and willing to undergo computed tomography (CT) and magnetic resonance imaging (MRI) * Subjects must be willing to participate in study related exercises to the extent possible * Able to undergo all planned neurological assessments
Exclusion criteria
* History or presence of any other major neurological disease * Any seizures in the prior 3 months * The presence of contracture at any joints that would interfere with interpretation of any of the neurological assessments (e.g. contracture preventing the detection of any increase in the range of motion or ability to perform a task) * Other neurologic, neuromuscular or orthopedic disease that limits motor function * Clincially significant finding on MRI of brain not related to TBI * Known presence of any malignancy except squamous or basal cell carcinoma of the skin * History of CNS malignancy * Positive findings on tests for occult malignancy, unless a non-malignant etiology is confirmed * Uncontrolled systemic illness, including, but not limited to: hypertension (systolic \>150 mm Hg or diastolic \>95 mm Hg); diabetes; renal, hepatic, or cardiac failure * Uncontrolled major psychiatric illness, including depression symptoms (CESD-R Scale of ≥16) * Unexplained abnormal preoperative test values (blood tests, electrocardiogram \[ECG\], chest X-ray); x-ray evidence of infection; uncontrolled atrial fibrillation or uncontrolled congestive heart failure * Presence of craniectomy (without bone flap replacement) or other contraindication to stereotactic surgery * Participation in any other investigational trial within 4 weeks of initial screening or within 7 weeks of study entry * Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) 16 weeks priot to the Baseline visit. * Ongoing use of other non-traditional drugs * Substance use disorder (per DSM-V criteria, including drug or alcohol) * Contraindications to head CT or MRI * Pregnant or lactating * Female patients of childbearing potential unwilling to use an adequate birth control method during the 12 months of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients | 24 weeks | The FMMS motor component consists of the 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items were then summed to determine scores for the 2 subscale scores, as well as a motor total score (total of all item scores including the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients | 24 weeks | DRS is an observer rated, 30-point ordinal scale that evaluates eight areas of functioning in four categories: 1. Consciousness (eye opening, verbal response, motor response) 2. Cognitive ability (feeding, toileting, grooming) 3. Dependence on others 4. Employability Each area of functioning was rated on a scale of 0 to either 3 or 5. The maximum score is 29 (extreme vegetative state) and the minimum score is 0 (person without disability). |
| Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients | 24 weeks | The ARAT total score is the sum of the scores from 19 tests spread across four subscales: grasp, grip, pinch, and gross movement. Each test is scored on an ordinal 4-point scale with 0= non movement, 1 = the movement task is partially performed, 2 = the movement task is completed but takes abnormally long, and 3 = the movement is performed normally. Summation of a 0-3 score in each item yields a total score between 0 and 57. |
| Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients | 24 weeks | Gait Velocity was measured on a standard 10 meter walk. |
| Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | 24 weeks | Two NeuroQoL short form assessments were used (upper extremity function and lower extremity function); each has 8 items with 5 possible scores (e.g. 1= not at all, 2=a little bit, 3= somewhat, 4=quite a bit, 5=very much) or frequency (neverto always); Raw scores are converted to T-scores based on a consistent metric (i.e., the T distribution) and data from the US general population. The theoretical range in scale for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively. When interpreting these T-scores, higher scores correspond to higher levels of functioning whereas lower scores correspond to lower levels of functioning. |
| Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | 24 weeks | The proportions of SB623 treated subjects (pooling all SB623 doses) scoring either 7 (much better) or 6 (a little better, meaningful) on the Global Rating of Perceived Change (from Baseline) - Subject at Week 24 and on the Global Rating of Perceived Change (from Baseline) - Clinician at Week 24 was compared to the corresponding proportions of sham surgery control subjects using logistic regression models with adjustment for the baseline Fugl-Meyer Motor Scale score and the GOS-E score at screening as continuous covariates. The following 7-point Likert scale was used * Score 7 = Much better * Score 6 = A little better, meaningful * Score 5 = A little better, not meaningful * Score 4 = About the same * Score 3 = A little worse, not meaningful * Score 2 = A little worse, meaningful * Score 1 = Much worse |
Countries
Japan, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group: 2.5 Million Cells 2.5 million SB623 cells
SB623 surgically implanted | 15 |
| Treatment Group: 5 Million Cells 5 million SB623 cells
SB623 surgically implanted | 15 |
| Treatment Group: 10 Million Cells 10 million SB623 cells
SB623 surgically implanted | 16 |
| Sham Surgery Control Sham Surgery
Sham Control: Sham Surgery | 15 |
| Total | 61 |
Baseline characteristics
| Characteristic | Treatment Group: 2.5 Million Cells | Treatment Group: 5 Million Cells | Treatment Group: 10 Million Cells | Sham Surgery | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.66 years STANDARD_DEVIATION 13.57 | 31.22 years STANDARD_DEVIATION 9.15 | 34.23 years STANDARD_DEVIATION 11.46 | 35.48 years STANDARD_DEVIATION 12.96 | 34.40 years STANDARD_DEVIATION 11.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 14 Participants | 15 Participants | 15 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 5 Participants | 4 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 9 Participants | 11 Participants | 11 Participants | 42 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 5 Participants | 6 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 11 Participants | 9 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 15 / 15 | 15 / 15 | 16 / 16 | 14 / 15 |
| serious Total, serious adverse events | 1 / 15 | 1 / 15 | 2 / 16 | 3 / 15 |
Outcome results
Primary
Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients
The FMMS motor component consists of the 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items were then summed to determine scores for the 2 subscale scores, as well as a motor total score (total of all item scores including the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance).
Time frame: 24 weeks
Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure (61 subjects)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: 2.5 Million Cells | Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients | 6.0 Change in score on a scale from baseline | Standard Deviation 10.1 |
| Treatment Group: 5 Million Cells | Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients | 11.0 Change in score on a scale from baseline | Standard Deviation 8.4 |
| Treatment Group: 10 Million Cells | Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients | 8.1 Change in score on a scale from baseline | Standard Deviation 12.8 |
| Sham Surgery | Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients | 2.3 Change in score on a scale from baseline | Standard Deviation 4.7 |
Comparison: Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.p-value: 0.0401Mixed Models Analysis
Secondary
Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients
The ARAT total score is the sum of the scores from 19 tests spread across four subscales: grasp, grip, pinch, and gross movement. Each test is scored on an ordinal 4-point scale with 0= non movement, 1 = the movement task is partially performed, 2 = the movement task is completed but takes abnormally long, and 3 = the movement is performed normally. Summation of a 0-3 score in each item yields a total score between 0 and 57.
Time frame: 24 weeks
Population: The Modified Intent-to-Treat (mITT) population included all randomized subjects who completed the surgery treatment procedure. Only subjects in the mITT population who have the value available for Change from Baseline in ARAT at 24 weeks are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: 2.5 Million Cells | Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients | 3.0 Change in score on a scale from baseline | Standard Deviation 6.7 |
| Treatment Group: 5 Million Cells | Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients | 4.2 Change in score on a scale from baseline | Standard Deviation 5.2 |
| Treatment Group: 10 Million Cells | Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients | -0.3 Change in score on a scale from baseline | Standard Deviation 10.3 |
| Sham Surgery | Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients | -0.4 Change in score on a scale from baseline | Standard Deviation 11.5 |
Comparison: Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.p-value: 0.339895% CI: [-2.9, 8.3]Mixed Models Analysis
Secondary
Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients
DRS is an observer rated, 30-point ordinal scale that evaluates eight areas of functioning in four categories: 1. Consciousness (eye opening, verbal response, motor response) 2. Cognitive ability (feeding, toileting, grooming) 3. Dependence on others 4. Employability Each area of functioning was rated on a scale of 0 to either 3 or 5. The maximum score is 29 (extreme vegetative state) and the minimum score is 0 (person without disability).
Time frame: 24 weeks
Population: The Modified Intent-to-Treat (mITT) population included all randomized subjects who completed the surgery treatment procedure. Only subjects in the mITT population who have the value available for Change from Baseline in DRS at 24 weeks are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: 2.5 Million Cells | Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients | -0.1 Change in score on a scale from baseline | Standard Deviation 1.2 |
| Treatment Group: 5 Million Cells | Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients | -1.4 Change in score on a scale from baseline | Standard Deviation 2.6 |
| Treatment Group: 10 Million Cells | Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients | -0.6 Change in score on a scale from baseline | Standard Deviation 2.2 |
| Sham Surgery | Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients | 0.6 Change in score on a scale from baseline | Standard Deviation 1.6 |
Comparison: Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.p-value: 0.165595% CI: [-1.7, 0.3]Mixed Models Analysis
Secondary
Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients
Gait Velocity was measured on a standard 10 meter walk.
Time frame: 24 weeks
Population: The Modified Intent-to-Treat (mITT) population included all randomized subjects who completed the surgery treatment procedure. Only subjects in the mITT population who have the value available for Change from Baseline in Gait Velocity at 24 weeks are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: 2.5 Million Cells | Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients | -3.1 10 meter walk change of time in seconds | Standard Deviation 87 |
| Treatment Group: 5 Million Cells | Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients | -3.9 10 meter walk change of time in seconds | Standard Deviation 6.7 |
| Treatment Group: 10 Million Cells | Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients | -2.2 10 meter walk change of time in seconds | Standard Deviation 113.6 |
| Sham Surgery | Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients | -2.4 10 meter walk change of time in seconds | Standard Deviation 6.7 |
Comparison: Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.p-value: 0.897495% CI: [-42.2, 37.1]Mixed Models Analysis
Secondary
Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains
Two NeuroQoL short form assessments were used (upper extremity function and lower extremity function); each has 8 items with 5 possible scores (e.g. 1= not at all, 2=a little bit, 3= somewhat, 4=quite a bit, 5=very much) or frequency (neverto always); Raw scores are converted to T-scores based on a consistent metric (i.e., the T distribution) and data from the US general population. The theoretical range in scale for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively. When interpreting these T-scores, higher scores correspond to higher levels of functioning whereas lower scores correspond to lower levels of functioning.
Time frame: 24 weeks
Population: The Modified Intent-to-Treat (mITT) population included all randomized subjects who completed the surgery treatment procedure. Only subjects in the mITT population who have the value available for Change from Baseline in NeuroQOL T-scores at 24 weeks are included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: 2.5 Million Cells | Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | Change in T-score from baseline (upper extremity function) | 5.66 Change in score on a scale from baseline | Standard Deviation 8.06 |
| Treatment Group: 2.5 Million Cells | Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | Change in T-score from baseline (lower extremity function) | 3.06 Change in score on a scale from baseline | Standard Deviation 6.58 |
| Treatment Group: 5 Million Cells | Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | Change in T-score from baseline (lower extremity function) | 1.95 Change in score on a scale from baseline | Standard Deviation 6.82 |
| Treatment Group: 5 Million Cells | Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | Change in T-score from baseline (upper extremity function) | 5.27 Change in score on a scale from baseline | Standard Deviation 8.9 |
| Treatment Group: 10 Million Cells | Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | Change in T-score from baseline (upper extremity function) | -0.77 Change in score on a scale from baseline | Standard Deviation 6.42 |
| Treatment Group: 10 Million Cells | Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | Change in T-score from baseline (lower extremity function) | 3.38 Change in score on a scale from baseline | Standard Deviation 7.1 |
| Sham Surgery | Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | Change in T-score from baseline (upper extremity function) | 2.48 Change in score on a scale from baseline | Standard Deviation 9.89 |
| Sham Surgery | Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains | Change in T-score from baseline (lower extremity function) | 1.75 Change in score on a scale from baseline | Standard Deviation 7.05 |
Comparison: Change from Baseline in NeuroQOL Upper Extremity Function T Score at Week 24p-value: 0.853495% CI: [-5.77, 4.8]Mixed Models Analysis
Comparison: Change from Baseline in NeuroQOL Lower Extremity Function T Score at Week 24p-value: 0.844395% CI: [-3.78, 4.6]Mixed Models Analysis
Secondary
Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician
The proportions of SB623 treated subjects (pooling all SB623 doses) scoring either 7 (much better) or 6 (a little better, meaningful) on the Global Rating of Perceived Change (from Baseline) - Subject at Week 24 and on the Global Rating of Perceived Change (from Baseline) - Clinician at Week 24 was compared to the corresponding proportions of sham surgery control subjects using logistic regression models with adjustment for the baseline Fugl-Meyer Motor Scale score and the GOS-E score at screening as continuous covariates. The following 7-point Likert scale was used * Score 7 = Much better * Score 6 = A little better, meaningful * Score 5 = A little better, not meaningful * Score 4 = About the same * Score 3 = A little worse, not meaningful * Score 2 = A little worse, meaningful * Score 1 = Much worse
Time frame: 24 weeks
Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Treatment Group: 2.5 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Clinician at Week 24 | Scoring either 6 or 7 on the Global Rating (No) | 10 Participants |
| Treatment Group: 2.5 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Subject at Week 24 | Scoring either 6 or 7 on the Global Rating (Yes) | 8 Participants |
| Treatment Group: 2.5 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Subject at Week 24 | Scoring either 6 or 7 on the Global Rating (No) | 7 Participants |
| Treatment Group: 2.5 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Clinician at Week 24 | Scoring either 6 or 7 on the Global Rating (Yes) | 5 Participants |
| Treatment Group: 5 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Subject at Week 24 | Scoring either 6 or 7 on the Global Rating (Yes) | 12 Participants |
| Treatment Group: 5 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Subject at Week 24 | Scoring either 6 or 7 on the Global Rating (No) | 3 Participants |
| Treatment Group: 5 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Clinician at Week 24 | Scoring either 6 or 7 on the Global Rating (Yes) | 6 Participants |
| Treatment Group: 5 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Clinician at Week 24 | Scoring either 6 or 7 on the Global Rating (No) | 9 Participants |
| Treatment Group: 10 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Subject at Week 24 | Scoring either 6 or 7 on the Global Rating (No) | 10 Participants |
| Treatment Group: 10 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Subject at Week 24 | Scoring either 6 or 7 on the Global Rating (Yes) | 6 Participants |
| Treatment Group: 10 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Clinician at Week 24 | Scoring either 6 or 7 on the Global Rating (Yes) | 4 Participants |
| Treatment Group: 10 Million Cells | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Clinician at Week 24 | Scoring either 6 or 7 on the Global Rating (No) | 12 Participants |
| Sham Surgery | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Clinician at Week 24 | Scoring either 6 or 7 on the Global Rating (Yes) | 2 Participants |
| Sham Surgery | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Subject at Week 24 | Scoring either 6 or 7 on the Global Rating (Yes) | 4 Participants |
| Sham Surgery | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Clinician at Week 24 | Scoring either 6 or 7 on the Global Rating (No) | 13 Participants |
| Sham Surgery | Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician | Subject at Week 24 | Scoring either 6 or 7 on the Global Rating (No) | 11 Participants |