Actively Recruiting
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Led by Hope Biosciences LLC · Updated on 2025-09-29
51
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hope Biosciences LLC
Lead Sponsor
T
The University of Texas Health Science Center, Houston
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and potential treatment effects of intravenous infusions of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) from Hope Biosciences for people with chronic traumatic brain injury. This Phase 2a randomized, double-blind, placebo-controlled study aims to assess changes in brain structure, cognitive and functional outcomes, and neuroinflammation after the injury. The study focuses on adults with neurological damage from closed head trauma that is unlikely to improve with current standard care. Participants will receive three infusions of HB-adMSCs or a placebo (normal saline) over six weeks, with 14 days between each infusion. Each dose contains 2 x 10^8 total cells for the treatment group. Safety monitoring includes observation for at least one hour after each infusion and a follow-up call 24 hours later. Additional safety visits occur at 6 months, 12 months, and 2 years after the last infusion to check for any adverse effects or complications. During the study, participants undergo various assessments including blood tests to measure multiple biochemical markers at baseline, during infusions, and up to one year post-infusion. Brain imaging with MRI and PET/DT-MRI scans will be done at baseline and 6 months post-infusion. Functional and cognitive tests, as well as quality of life questionnaires, will be conducted at baseline, 6 months, and 1 year to evaluate brain function and recovery. The total study participation extends up to two years with regular monitoring and follow-up evaluations.
CONDITIONS
Brief Title
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between 18 and 55 years of age
- Documented functional neurological damage to the central nervous system from closed head trauma unlikely to improve with current standard care
- Glasgow Outcome Scale-Extended (GOS-E) score greater than 2 and less than or equal to 6
- Injury or diagnosis onset greater than 6 months and less than or equal to 20 years ago
- Ability to provide consent or have a legally authorized representative consent
- Ability to verbally communicate in English or Spanish for cognitive testing
You will not qualify if you...
- Known intellectual deficiency or uncontrolled psychiatric conditions affecting cognition or behavior assessment
- Recent infection treatment
- Renal disease or impaired kidney function (eGFR less than 60 mL/min/1.73m2)
- Liver disease or impaired liver function (SGPT over 150 U/L or total bilirubin over 1.3 mg/dL)
- Cancer
- Immunosuppression (white blood cells under 3,000 cells/ml)
- Positive tests for HIV, Hepatitis B, Hepatitis C, or Syphilis
- Chemical or alcohol dependency preventing enrollment
- Acute or chronic lung disease requiring significant medication or oxygen
- Bleeding disorders including immune-mediated heparin-induced thrombocytopenia
- Known sensitivity to heparin, Lovenox, or pork products
- Mechanical prosthetic heart valves
- Previous stem cell, gene, or cellular therapy
- Normal brain CT or MRI exam
- History of spinal cord injury
- Genetic or metabolic neurologic disorders
- Other medical conditions increasing study risk
- Positive pregnancy test or unwillingness to use birth control
- Participation in other interventional drug or device studies
- Inability or unwillingness to undergo diagnostic tests or cooperate with assessments
- Metal implants such as baclofen pumps preventing DT-MRI
- Unwillingness or inability to attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive three infusions of autologous adipose-derived mesenchymal stem cells or placebo over a 6 week period with 14 day intervals between infusions. Participants are monitored for infusion related toxicity during and after each infusion.
3 infusion visits with 1 hour monitoring after each infusion and telephone follow-up 24 hours after each infusion
Duration - Up to 2 years after treatment
Participants are monitored and assessed for safety and treatment effects at 6 months, 12 months, and 2 years after the last infusion, with some assessments conducted by telephone.
In-person visits at 6 and 12 months, telephone visit at 2 years
Trial Site Locations
Total: 2 locations
1
Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston
Houston, Texas, United States, 77030
Actively Recruiting
2
The University of Texas Health Science at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
C
Carmen Duron, RN, MHA, BSN
C
Carla Mendoza, BSN, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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