A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Biological: HB-adMSCs

Detailed Description

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on global gray and/or white matter, as well as structural integrity of GM and WM regions of interest in the corpus callous and corticospinal tracts as measured by fractional anisotropy (FA) and mean diffusivity (MD) in specific regions known to correlate with specific neurocognitive deficits in patients after neurological injury.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. adults between 18 and 55 years of age
2. documented head injury with functional neurological damage to the central nervous system unlikely to improve with present standard of care approaches
3. a Glasgow Outcome Scale-Extended (GOS-E) score > 2 and ≤ 6
4. onset or diagnosis of the injury or disease process greater than 6 months
5. ability to obtain consent from the subject of their legally authorized representative (LAR)
6. ability to speak English or Spanish *required for validated neurocognitive outcome testing) -

Exclusion Criteria:

1. known history of:

   1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
   2. recently treated infection,
   3. renal disease or altered renal function (screening serum creatinine > 1.5 mg/dL),
   4. hepatic disease or altered liver function (screening SGPT > 150 U/L or T. Bilirubin >1.3 mg/dL),
   5. cancer,
   6. immunosuppression (screening WBC < 3, 000 cells/ml),
   7. HIV+,
   8. chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
   9. acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation,
   10. bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
   11. known sensitivity to heparin, Lovenox, and pork products,
   12. individuals with mechanical prosthetic heart valves.
   13. individuals who have received a stem cell treatment.
2. Normal brain CT/MRI exam
3. Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam
4. diagnosed with a genetic or metabolic disorder related to the neurologic condition
5. other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation
6. for women of child bearing potential, a positive pregnancy test at the screening visit, or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study
7. participation in a concurrent interventional study
8. inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments
9. unwilling or unable to return for follow-up study visits -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HB-adMSC; HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)	Biological: HB-adMSCs; Hope Biosciences autologous adipose-derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Signs (Respiratory Rate)	Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Respiratory Rate	Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Vital Signs (Temperature)	Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Temperature	Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Vital Signs (Systolic Blood Pressure)	Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Systolic Blood Pressure	Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Vital Signs (Diastolic Blood Pressure)	Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Diastolic Blood Pressure	Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Vital Signs (Pulse Rate)	Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Pulse Rate	Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Vital Signs (Oxygen Saturation)	Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Oxygen Saturation	Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Vital Signs Change From Baseline (Diastolic Blood Pressure)	Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Diastolic Blood Pressure	Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Vital Signs Change From Baseline (Systolic Blood Pressure)	Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Systolic Blood Pressure	Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Vital Signs Change From Baseline (Pulse Rate)	Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Pulse Rate	Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Vital Signs Change From Baseline (Oxygen Saturation)	Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Oxygen Saturation	Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Vital Signs Change From Baseline (Respiratory Rate)	Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Respiratory Rate	Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)
Vital Signs Change From Baseline (Temperature)	Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Temperature	Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin 4	IL-4 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 1940 pg/mL to 6060 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Interleukin 2	IL-2 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 363 pg/mL to 1909 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Interleukin 1-beta	IL-1-beta lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1615 pg/mL to 6930 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Interferon Gamma-induced Protein 10 (IP-10)	IP-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 5270 pg/mL to 15466 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Tumor Necrosis Factor Alpha	TNFα lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values ranged from 232 pg/mL to 4570 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Monocyte Chemoattractant Protein-1 (MCP-1)	MCP-1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1439 pg/mL to 7472 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Interleukin Protein-17A (IL-17a)	IL-17a lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values measure 526 pg/mL to 3228 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Interleukin 6	IL-6 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 750 pg/mL to 4740 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Interleukin 10	IL-10 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 497 pg/mL to 2796 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
IFN-gamma	IFN-gamma lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 764 pg/mL to 6591 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
IL-12p70	IL-12p70 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 676 pg/mL to 3975 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
IL-8	IL-8 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 1348 pg/mL to 7738 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Free Active TGF-Beta1	Free active TGF-Beta1 lab measure of patients from a bead-based, ELISA/Flow Cytometry combination assay to evaluate cytokine measures at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56) Values range from 799 pg/mL to 7374 pg/mL	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes	Count of Participants with specific GOS-E scores at Visits 3, 6, and 7 Glasgow Outcome Scale-Extended is an 8-point scale that classifies the global outcome for individuals with traumatic brain injury (TBI), ranging from 1 (dead) to 8 (upper good recovery). The categorical rating is based on a structured interview about the patient's ability to function. Higher scores indicate better recovery. Category 3 is Lower Severe Disability, Category 4 is Upper Severe Disability, Category 5 is Lower Moderate Disability, and Category 6 is Upper Moderate Disability.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Disability Rating Scale (DRS) Functional Outcomes	Mean and SD of Disability Rating Scale (DRS) evaluation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Disability Rating Scale score provides a numerical measure of an individual's functional impairment and disability. This assessment uses a 0-30 total score to assess traumatic brain injury, with higher scores indicating greater disability. A score of 0 indicates a rating of "no disability" and a score of 30 indicates a rating of "profound vegetative state".	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Galveston Orientation and Amnesia Test Neuropsychological Outcomes	Mean and SD of Galveston Orientation and Amnesia Test (GOAT) evaluation of cognition at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The total score is calculated by subtracting an "error score" from 100. The error score is calculated by summing together the individual error score points from each question. The minimum total score of -3 is associated with a failure to respond correctly to any memory/orientation question. A total score of 100 indicates perfect recall on the GOAT memory/orientation questions. Higher total scores indicate better recall.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Brief Symptoms Inventory 18 (BSI 18) SOM T Scores	Brief Symptoms Inventory 18 (BSI 18) Somatization (SOM) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Brief Symptoms Inventory 18 (BSI 18) DEP T Scores	Brief Symptoms Inventory 18 (BSI 18) Depression (DEP) T-Score Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores	Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. A T-score is then calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores	Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The BSI-18 has three subscores (somatization, depression, and anxiety) each with a raw score of 0 to 24, with higher scores indicating greater distress. The Global Severity Index (GSI) is the sum of the three subscores, which was then normalized with a t-score in this analysis. A T-score was calculated by comparing to normative data. T-scores under 50 indicate no elevation and T-scores of 63 or higher suggests a clinically significant level of distress. T-scores are standardized to have an average of 50 and a standard deviation of 10. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores	TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores	TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores	TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores	TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores	TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction with SRA T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores	TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The TBI-QOL SF consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized. A score of 60 is above average and a score of 40 is below average.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores	NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
NIH Toolbox - Cognition: Picture Vocabulary Test T Scores	NIH Toolbox - Cognition: Picture Vocabulary Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56)
NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores	NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores	NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores	NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores	NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores	NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The NIH Toolbox consists of multiple subsections that are summed individually to create a raw score for each subsection. Then, a T-score was calculated by comparing to normative data. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more of the measured construct was observed, whether it is a positive construct or a negative construct. Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores	Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Delay Test consists of calculating the total number of words recalled on the delayed recall trial (after a 20-30 minute delay). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores	Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 Test consists of calculating the total number of words correctly recalled across the five initial learning trials (Trials 1-5). Then, a T-score is calculated by comparing to normative data adjusted for age and education to determine performance relative to peers. T-scores are standardized to have an average of 50 and a standard deviation of 10. A higher T-score indicates more words were recalled (better outcomes). Technically there is no minimum or maximum t-score since it is normalized.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores	Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores	Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores	Wechsler Adult Intelligence Scale - IV: Processing Speed Composite Scores Means and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The subsection (such as Coding) raw scores are converted into a scaled score with a mean of 10 and a standard deviation of 3. This process is standardized using age-based conversion tables. Then, these scaled scores are combined into index scores which are compared to a normative population with a standard score (mean = 100, SD = 15) to create an index score and fall into ranges of "Average" being 90-109, "High Average" 110-119, "Low Average" 80-89, "Borderline" 70-79, and "Extremely Low" below 70. Higher scores mean better outcome.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
Controlled Oral Word Association Test (COWAT) Total Scaled Scores	Controlled Oral Word Association Test (COWAT) Total Scaled Scores Mean and Standard Deviations at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56). The COWAT is scored by counting the number of correct words a person produces in one minute for each of the three given letters. The total score is the sum of the unique words generated across all three trials. Higher scores are considered a better outcome. The raw total score is then compared to normative data that is based on factors such as age and education level. The scaled score has a mean of 10 and a standard deviation of 3. A t-score of < 20 indicates severe impairment.	Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)
MRI Structural Measures - Global White Matter	MRI Structural Measures - Global White Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Global Gray Matter	MRI Structural Measures - Global Gray Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Global Corpus Callosum Matter	MRI Structural Measures - Global Corpus Callosum Matter Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Hippocampus (Bilateral)	MRI Structural Measures - Hippocampus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Amygdala (Bilateral)	MRI Structural Measures - Amygdala (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Thalamus (Bilateral)	MRI Structural Measures - Thalamus (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Caudate (Bilateral)	MRI Structural Measures - Caudate (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Putamen (Bilateral)	MRI Structural Measures - Putamen (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Pallidum (Bilateral)	MRI Structural Measures - Pallidum (bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Insula (Bilateral)	MRI Structural Measures - Insula (Bilateral) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Hippocampus (Left)	MRI Structural Measures - Hippocampus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Hippocampus (Right)	MRI Structural Measures - Hippocampus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Amygdala (Left)	MRI Structural Measures - Amygdala (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Amygdala (Right)	MRI Structural Measures - Amygdala (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Thalamus (Left)	MRI Structural Measures - Thalamus (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Thalamus (Right)	MRI Structural Measures - Thalamus (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Caudate (Left)	MRI Structural Measures - Caudate (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Caudate (Right)	MRI Structural Measures - Caudate (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Putamen (Left)	MRI Structural Measures - Putamen (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Putamen (Right)	MRI Structural Measures - Putamen (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Pallidum (Left)	MRI Structural Measures - Pallidum (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Pallidum (Right)	MRI Structural Measures - Pallidum (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Insula (Left)	MRI Structural Measures - Insula (left) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)
MRI Structural Measures - Insula (Right)	MRI Structural Measures - Insula (right) Volumes Mean and Standard Deviation at the following timepoints: Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28). SupraMD is a type of mean diffusivity MRI that uses water diffusion within brain tissue to measure volume of various types of brain matter in mm3.	Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28)

Collaborators and Investigators

• Sponsor: Hope Biosciences LLC
• Collaborators: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Charles S Cox, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 17, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: stroke; chronic; cerebral palsy; severe; intracranial hemorrhage; hypoxic-ischemic encephalopathy; neurological injury
• Additional Relevant MeSH Terms: Organizing Pneumonia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms; Immune System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Hemorrhage; Lung Diseases; Brain Ischemia; Bronchial Diseases; Lung Diseases, Obstructive; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Signs and Symptoms, Respiratory; Lymphoma; Craniocerebral Trauma; Brain Damage, Chronic; Brain Injuries; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Hypoxia, Brain; Hypoxia; Graft vs Host Disease; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Brain Injuries, Traumatic; Bronchiolitis Obliterans Syndrome; Stroke; Cerebral Palsy; Lymphoma, Follicular; Hypoxia-Ischemia, Brain; Intracranial Hemorrhages; Trauma, Nervous System
• Other Study ID Numbers: HBTBI01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No