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
137 weeks
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
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.
CONDITIONS
Official 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 neurological damage to the central nervous system from closed head trauma unlikely to improve with standard care
- Glasgow Outcome Scale-Extended score greater than 2 and less than or equal to 6
- Injury onset or diagnosis more than 6 months and up to 20 years ago
- Ability to provide informed consent personally or via a legally authorized representative
- Ability to verbally communicate in English or Spanish for cognitive testing
You will not qualify if you...
- Intellectual disability or uncontrolled psychiatric conditions affecting cognitive or behavioral assessments
- Recent infection treatment
- Kidney disease or impaired kidney function (eGFR less than 60 mL/min/1.73m2)
- Liver disease or abnormal liver function (SGPT over 150 U/L or total bilirubin over 1.3 mg/dL)
- Cancer
- Immunosuppression (white blood cell count less than 3,000 cells/ml)
- Positive tests for HIV, Hepatitis B, Hepatitis C, or Syphilis
- Chemical or alcohol dependency deemed unsuitable by investigator
- Acute or chronic lung disease requiring significant medication or oxygen
- Bleeding disorders including immune-mediated heparin-induced thrombocytopenia
- Known allergy to heparin, Lovenox, or pork products
- Mechanical prosthetic heart valves
- Prior stem cell, gene, or cellular therapy
- Normal brain CT or MRI exam
- History of spinal cord injury
- Genetic or metabolic neurological disorders
- Other medical conditions increasing study risks per investigator
- Positive pregnancy test or unwillingness to use birth control
- Participation in other drug or device studies
- Inability or unwillingness to undergo diagnostic tests or assessments
- Presence of metal implants preventing DT-MRI
- Unwilling or unable to attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Carla Mendoza, BSN, RN
CONTACT
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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