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

Part of paid clinical trials in Houston, Texas.

Sponsor
Hope Biosciences LLC
Study ID
NCT05951777
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous HB-adMSCs — BIOLOGICAL
    Hope Biosciences autologous adipose-derived mesenchymal stem cells
  • Normal Saline — DRUG
    Sterile Saline Solution 0.9%

Study Details

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.

Key Dates

Start date
Apr 16, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Autologous Adipose Derived Mesenchymal Stem Cells
  • Placebo Comparator: Placebo
    Normal Saline

Primary Outcome Measure

Glucose [ Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Hermann Hospital / UTHealth McGovern Medical School at HoustonHoustonTexas77030
Carmen Duron, MHA, BSN, RN
[email protected]
713-500-7395
Carla Mendoza, BSN, RN
[email protected]
713-500-8206
Charles S Cox, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science at San AntonioSan AntonioTexas78229
John Moring, PhD
[email protected]
210-562-6716
Sarabeth Fox
[email protected]
210-415-4792
Peter T Fox, MD (PRINCIPAL_INVESTIGATOR)
John C Moring, PhD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston· Houston, TXThe University of Texas Health Science at San Antonio· San Antonio, TX

Related Studies