Treatment of Severe Adult Traumatic Brain Injury Using Bone Marrow Mononuclear Cells
Charles S Cox1, Robert A Hetz2, George P Liao2
1Department of Pediatric Surgery, The University of Texas McGovern Medical School, Houston, Texas, USA.
Stem Cells (Dayton, Ohio)
|November 2, 2016
Summary
Autologous bone marrow mononuclear cell infusions are safe and feasible for treating severe adult traumatic brain injury (TBI). This treatment demonstrated central nervous system structural preservation and reduced inflammatory biomarkers, suggesting a potential therapeutic effect for TBI patients.
Area of Science:
- Regenerative Medicine
- Neuroscience
- Cell Therapy
Background:
- Preclinical studies show bone marrow cells preserve the blood-brain barrier and improve outcomes in traumatic brain injury (TBI).
- Phase 1 trials in children with severe TBI indicated safety and potential for central nervous system (CNS) structural preservation with bone marrow mononuclear cells (BMMNCs).
Purpose of the Study:
- To confirm the safety, logistic feasibility, and potential treatment effect size of structural preservation and inflammatory biomarker mitigation in adults with severe TBI.
- To guide the design of future Phase 2 clinical trials for TBI treatment.
Main Methods:
- A dose-escalation study involving 25 adult TBI patients (Glasgow Coma Scale 5-8) receiving autologous BMMNC infusions within 48 hours of injury.
- Monitoring for adverse events, including harvest-related hemodynamic changes and infusional toxicity.
- Outcome assessment included MRI and diffusion tensor imaging (DTI) for structural preservation, functional and neurocognitive testing, and plasma inflammatory cytokine analysis at 1 and 6 months post-injury.
Main Results:
- No serious adverse events were reported; mild, clinically insignificant pulmonary toxicity occurred at the highest dose.
- Despite greater injury severity in the treatment group, significant structural preservation in critical CNS regions was observed, correlating with functional outcomes.
- Key inflammatory cytokines were downregulated post-treatment, and BMMNC infusion demonstrated a potential treatment signal for CNS structural preservation.
Conclusions:
- Intravenously delivered autologous BMMNC infusion is a safe and logistically feasible treatment for severe adult TBI.
- The study provides evidence of a treatment effect, including CNS structural preservation and reduced inflammation, supporting previous pediatric findings.
- Results support the advancement of BMMNC therapy for TBI into Phase 2 clinical trials.
Keywords:
adult human bone marrowadult stem cellsbone marrow stromal cellscellular therapyclinical trialsdiffusion tensor imagingtraumatic brain injuryMore Related Videos
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