Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Hope Biosciences LLC
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.
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…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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).…
Interventions
- BiologicalAutologous HB-adMSCs
Hope Biosciences autologous adipose-derived mesenchymal stem cells
- DrugNormal Saline
Sterile Saline Solution 0.9%
Locations (2)
- Memorial Hermann Hospital / UTHealth McGovern Medical School at HoustonHouston, Texas
- The University of Texas Health Science at San AntonioSan Antonio, Texas