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.
| Condition(s) | Traumatic Brain Injury |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 discreti |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Lead sponsor | Hope Biosciences LLC |
| Locations | Houston, Texas, United States; San Antonio, Texas, United States |
| Start date | 2024-04-16 |
| NCT ID | NCT05951777 |
| Official listing | https://clinicaltrials.gov/study/NCT05951777 |