Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Biological: Autologous HB-adMSCs; Drug: Normal Saline

Detailed Description

This study is a prospective, randomized, double-blind, placebo-controlled Phase 2a study of three infusions of autologous HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) (2 x 10^8 total cells per dose) administered over a 6 week period with 14 day intervals between infusions. Subjects will be monitored and assessed for infusion related toxicity for at least 1 hour after the infusion and by telephone 24hr. after each infusion. Safety assessments will be conducted at the study follow-up clinic visits 6 and 12 months, and 2 years (telephone call) after the last HB-adMSC (Hope Biosciences adipose-derived mesenchymal stem cells) infusion, or more frequently if infusion related adverse events are suspected.

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Carmen Duron, RN, MHA, BSN; Phone Number: 713-500-7395; Email: Maria.Carmen.Duron@uth.tmc.edu
• Study Contact Backup: Name: Carla Mendoza, BSN, RN; Phone Number: 713-500-8206; Email: Carla.D.Wilkerson@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston
      • Principal Investigator: Charles S Cox, MD
      • Contact: Carmen Duron, MHA, BSN, RN; Phone Number: 713-500-7395; Email: Maria.Carmen.Duron@uth.tmc.edu
      • Contact: Carla Mendoza, BSN, RN; Phone Number: 713-500-8206; Email: Carla.D.Wilkerson@uth.tmc.edu
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • The University of Texas Health Science at San Antonio
      • Principal Investigator: Peter T Fox, MD
      • Sub-Investigator: John C Moring, PhD
      • Contact: John Moring, PhD; Phone Number: 210-562-6716; Email: MoringJ@uthscsa.edu
      • Contact: Sarabeth Fox; Phone Number: 210-415-4792; Email: foxs3@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults between 18 and 55 years of age.
2. Documented functional neurological damage to the central nervous system from closed head trauma that is 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 and <= 20 years.
5. Ability to obtain consent from the subject or their legally authorized representative (LAR).
6. Ability to verbally communicate in English or Spanish (required for validated neurocognitive outcome testing).

Exclusion Criteria:

1. Known history of:

   1. intellectual deficiency or uncontrolled psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, or at the discretion of the PI,
   2. recently treated infection,
   3. renal disease or altered renal function (screening eGFR < 60 mL/min/1.73m2),
   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. Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis,
   8. chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment,
   9. acute or chronic lung disease requiring significant medication/oxygen supplementation,
   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, gene or cellular therapy.
2. Normal brain CT/MRI exam.
3. History of spinal cord injury.
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 childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control.
7. Concurrent participation in interventional drug or device study.
8. Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
9. Metal implants including baclofen pumps that would preclude DT-MRI.
10. Unwilling or unable to return for the follow-up study visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Normal Saline	Drug: Normal Saline; Sterile Saline Solution 0.9%
Experimental: Treatment; Autologous Adipose Derived Mesenchymal Stem Cells	Biological: Autologous HB-adMSCs; Hope Biosciences autologous adipose-derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	clinical lab evaluation of level of glucose in the blood (mg/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Calcium	clinical lab evaluation of level of calcium in the blood (mg/dL) clinical lab evaluation of level of calcium in the blood (mg/dL) clinical lab evaluation of level of calcium in the blood (mg/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Albumin	clinical lab evaluation of level of albumin in the blood (g/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Total Protein	clinical lab evaluation of total protein in the blood (g/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Sodium	clinical lab evaluation of total sodium in the blood (mmol/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Total carbon dioxide	clinical lab evaluation of total carbon dioxide in the blood (mmol/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Potassium	clinical lab evaluation of potassium in the blood (mmol/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Chloride	clinical lab evaluation of chloride in the blood (mmol/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
BUN (blood urea nitrogen)	clinical evaluation of blood urea nitrogen (BUN) (mg/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Creatinine	clinical evaluation of creatinine in blood (mg/dL	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Alkaline phosphatase	clinical evaluation of alkaline phosphatase (ALP) in blood (IU/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Alanine aminotransferase	clinical evaluation of alanine aminotransferase (ALT) in blood (IU/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Aspartate aminotransferase	clinical evaluation of aspartate aminotransferase (AST) in blood (IU/L)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Total Bilirubin	clinical evaluation of total bilirubin in blood (mg/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
White blood cell	clinical evaluation of white blood cells (WBC) in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Red blood cell	clinical evaluation of red blood cells (RBC) in blood (x 10^6/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Hemoglobin	clinical evaluation of hemoglobin in blood (g/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Hematocrit	clinical evaluation of hematocrit in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Mean corpuscular volume	clinical evaluation of mean corpuscular volume (MCV) in blood (fL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Mean corpuscular hemoglobin	clinical evaluation of mean corpuscular hemoglobin (MCH) in blood (pg)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Mean corpuscular hemoglobin concentration	clinical evaluation of mean corpuscular hemoglobin concentration (MCHC) in blood (g/dL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Red cell distribution width	clinical evaluation of red cell distribution width (RDW) in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Neutrophils	clinical evaluation of neutrophils in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Lymphocytes	clinical evaluation of lymphocytes in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Monocytes	clinical evaluation of monocytes in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Eosinophils	clinical evaluation of eosinophils in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Basophils	clinical evaluation of basophils in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Absolute Neutrophils	clinical evaluation of absolute neutrophils in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Absolute lymphocytes	clinical evaluation of absolute lymphocytes in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Absolute monocytes	clinical evaluation of absolute monocytes in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Absolute eosinophils	clinical evaluation of absolute eosinophils in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Absolute basophils	clinical evaluation of absolute basophils in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Immature Granulocytes	clinical evaluation of immature granulocytes in blood (%)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Absolute Immature Granulocytes	clinical evaluation of absolute immature granulocytes in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Platelets	clinical evaluation of platelets in blood (x 10^3/uL)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Prothrombin Time	clinical evaluation of time for blood to coagulate (seconds)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
INR (international normalized ratio)	clinical evaluation of international normalized ratio of blood coagulation (no unit)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion
Urine Pregnancy (if applicable)	clinical evaluation of human chorionic gonadotropin (hCG) in urine (positive/negative)	Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole brain MRI (Magnetic resonance imaging)	DTI (Diffusion tensor imaging) to assess macro- and micro-structural properties	Baseline, change from baseline at 6 months post-infusion
PET/DT-MRI (positron emission tomography/Diffusion tensor-Magnetic resonance imaging)	[11C]ER-176 (a Radioligand for 18-kDa (Translocator Protein)) tracer/label to identify brain proteins associated with neuroinflammatory response regulation	Baseline, change from baseline at 6 months post-infusion
Glasgow Outcome Scale - Extended	Dichotomized-Glasgow Outcomes Score (GOSE) to evaluate affect, functional outcome, and neuropsychological function. Minimum score = 1 = dead; 2 = vegetative state; 3 = lower severe disability; 4 = upper severe disability; 5 = lower moderate disability; 6 = upper moderate disability; 7 = lower good recovery; Maximum score = 8 = upper good recovery; Higher scores indicate better outcome.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Behavior Rating of Executive Functions-Adult	Behavior Regulation and Metacognitive Indices assess everyday executive functions	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
TBI (Traumatic Brain Injury) Quality of Life Questionnaires	TBI-QOL SF (Traumatic Brain Injury-Quality of Life Short-Form) measures physical, psychological health, cognitive, and participation outcomes: Cognition: minimum raw score = 10, maximum raw score = 50. A higher score represents better functioning. Communication/Comprehension: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning. Independence: minimum raw score = 8, maximum raw score = 40. A higher score represents better functioning. Mobility: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning. Satisfaction with Social Roles & Activities: minimum raw score = 10, maximum raw score = 50. A higher score represents better functioning. Upper Extremity Function: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Brief Symptom Inventory 18	Brief Symptom Inventory with 18 items contains three six-item scales for somatization, anxiety, depression, and the global Scale Global Severity Index (GSI). Each item is scored either 0 (Not at all), 1 (A little bit), 2 (Moderately), 3 (Quite a bit), 4 (Extremely), or R (Refused). The GSI therefore ranges between 0 (minimum) - 72 (maximum) and the three scales range between 0 (minimum) - 24 (maximum). Higher scores indicate worse outcome.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
NIH Toolbox - Pattern Comparison Processing Speed Test	An assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. Participants are measured based on reaction time (seconds) and accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
NIH Toolbox - Dimensional Change Card Sort Test	An assessment of cognitive flexibility and attention. Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). Participants are measured based on reaction time (seconds) and accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
NIH Toolbox - Picture Vocabulary Test	An assessment of receptive vocabulary administered in a computer-adaptive test (CAT) format. Participants must choose which of four pictures best represents a word presented via audio. Participants are measured based on reaction time (seconds) and accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
NIH Toolbox - List Sorting Working Memory Test	Designed to assess working memory (WM). List Sorting is a sequencing task requiring participants to sort and sequence stimuli that are presented visually and auditorily. Participants are measured based on accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
NIH Toolbox - Flanker Inhibitory Control and Attention Test	An assessment of inhibitory control and attention. The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it. Participants are measured based on reaction time (seconds) and accuracy.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
NIH Toolbox - 9-hole Pegboard Dexterity Test	The NIH Toolbox 9-Hole Pegboard Dexterity Test is a simple test of manual dexterity; it records the time required for the participant to accurately place and remove nine plastic pegs into a plastic pegboard. Raw scores are recorded as time in seconds that it takes the participant to complete the task with each hand (a separate score for each - Dominant vs. Non-Dominant Hand). Shorter time to complete the task indicates a better outcome. Longer time to complete the task indicates a worse outcome.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Rey Auditory Verbal Learning Test	Immediate learning and delayed recall of a word list	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Verbal Fluency	Attentional control and verbal generativity	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Wechsler Adult Intelligence Scale - IV: Processing Speed Index	Information processing rate on paper-pencil tasks requiring visual attention. It is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests comprising the Full Scale IQ. There are four index scores representing major components of intelligence: Verbal Comprehension Index (VCI); Perceptual Reasoning Index (PRI); Working Memory Index (WMI); Processing Speed Index (PSI) Two broad scores are also generated, which can be used to summarize general intellectual abilities: Full Scale IQ (FSIQ), based on the total combined performance of the VCI, PRI, WMI, and PSI; General Ability Index (GAI), based only on the six subtests that comprise the VCI and PRI The range of possible WAIS-IV (Wechsler Adult Intelligence Scale - IV) full scale IQs is 45-155. The WAIS-IV computes scaled scores for each individual based exclusively on chronological age. Higher score indicates better outcome.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Plasma cytokines	measure plasma cytokines via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Interleukin 1-alpha	measure IL-1α (Interleukin 1-alpha) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Interleukin 4	measure IL-4 (Interleukin 4) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Tumor necrosis factor alpha	measure TNFα (Tumor necrosis factor alpha) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Interleukin 6	measure IL-6 via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Interleukin 10	measure IL-10 (Interleukin 10) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Albumin	measure concentration of albumin via BCG (bromocresol green) immunochemical analysis	Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Disability Rating Scale	Rating of level of arousal, cognitive ability related to activities of daily living, and level of functioning.	Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

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): April 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: chronic; severe; intracranial hemorrhage; 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; Bronchial Diseases; Lung Diseases, Obstructive; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Craniocerebral Trauma; Brain Injuries; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Brain Injuries, Traumatic; Bronchiolitis Obliterans Syndrome; Lymphoma, Follicular; Intracranial Hemorrhages; Trauma, Nervous System; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: HBTBI02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No