RecruitingPhase 2NCT05951777

Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury


Sponsor

Hope Biosciences LLC

Enrollment

51 participants

Start Date

Apr 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether stem cells taken from a patient's own fat tissue and injected back into their body can help treat the long-term effects of a traumatic brain injury (TBI). Researchers hope this approach may promote healing and improve neurological function in people with lasting disability from a head injury. **You may be eligible if...** - You are between 18 and 55 years old with confirmed chronic traumatic brain injury from a closed head trauma - Your injury happened at least 6 months ago and no more than 20 years ago - You have lasting neurological disability (GOS-E score between 3 and 6) - You can communicate in English or Spanish - Your injury is unlikely to improve with current standard treatments **You may NOT be eligible if...** - You have a history of cancer, HIV, hepatitis B or C, or syphilis - You have a serious intellectual disability or uncontrolled psychiatric condition - You have a history of spinal cord injury - You have liver or kidney disease at concerning levels - You have had prior stem cell, gene, or cellular therapy - You have metal implants that would prevent MRI scanning - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Houston

Houston, Texas, United States

The University of Texas Health Science at San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05951777


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