Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
NCT05951777 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2025-09-29
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.
Conditions
Interventions
- BIOLOGICAL
-
Autologous HB-adMSCs
Hope Biosciences autologous adipose-derived mesenchymal stem cells
- DRUG
-
Normal Saline
Sterile Saline Solution 0.9%
Sponsors & Collaborators
-
The University of Texas Health Science Center, Houston
collaborator OTHER -
Hope Biosciences LLC
lead INDUSTRY
Principal Investigators
-
Charles S Cox, MD · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-16
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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