Stem Cell Therapy for Brain Injury

Recruiting in Palo Alto (17 mi)

Overseen byCharles S Cox, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hope Biosciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and effects of infusing special stem cells (HB-adMSC) into adults with brain injuries. The goal is to see if these stem cells can help repair brain damage and reduce inflammation, potentially improving thinking and movement abilities. Researchers will look at changes in brain structure and function to determine the treatment's effectiveness.

Research Team

Charles S Cox, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

Adults aged 18-55 with traumatic brain injury or hypoxic-ischemic encephalopathy for over 6 months, who have a moderate to severe disability (GOS-E score >2 and ≤6), can consent, and speak English/Spanish. Excludes those with cancer, immune or bleeding disorders, severe lung disease, normal brain scans, certain heart valves/prosthetic issues, kidney/liver disease, HIV+, substance dependency or other conditions that may increase risk.

Inclusion Criteria

Your Glasgow Outcome Scale-Extended (GOS-E) score is higher than 2 but not more than 6.

You are able to obtain consent from the subject of your legally authorized representative (LAR) for the purpose of the test.

ability to speak English or Spanish *required for validated neurocognitive outcome testing) -

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Exclusion Criteria

You have HIV.

Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation

I have had spinal surgery, injury, or deformity confirmed by scans or exams.

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Treatment Details

Interventions

HB-adMSCs (Mesenchymal Stem Cell Therapy)

Trial OverviewThe trial is testing the safety and effectiveness of HB-adMSCs infusion therapy on adults with chronic neurological injuries. It evaluates how this treatment affects brain structure and function as well as inflammation in the nervous system.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: HB-adMSCExperimental Treatment1 Intervention

HB-adMSCs will be infused three times over a six week period, spaced 14 days apart