Stem Cell Therapy for Traumatic Brain Injury

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Anticonvulsants

Disqualifiers: Previous brain injury, Psychiatric condition, Seizure disorder, Renal disease, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 days

37 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the effect of intravenous infusion of autologous bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to determine if the intravenous infusion of autologous BMMNC after severe TBI results in structural preservation of global gray matter (GM) volume and white matter (WM) volume and integrity; as well as select regions of interest in the corpus callosum. THe secondary objectives are to determine if autologous BMMNC infusion improves functional and neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI; evaluate spleen size and splenic blood flow over time using ultrasound and corresponding changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up safety evaluations.

Research Team

Charles S Cox, MD

Principal Investigator

UTHealth McGovern Medical School, Houston, TX

Eligibility Criteria

Adults aged 18-55 with severe non-penetrating traumatic brain injury (TBI), measured by a Glasgow Coma Score of 3-8. Participants must be able to give consent through a legal representative and undergo treatment within 48 hours post-injury. Exclusions include immunosuppression, unwillingness for follow-up, certain pre-existing conditions, significant other injuries or infections, MRI contraindications, and pregnancy.

Inclusion Criteria

I can speak English or Spanish.

I can legally consent and undergo a procedure within 48 hours of my injury.

Non-penetrating closed head trauma

Exclusion Criteria

I have a known history of neurological issues.

I am on medication for seizures.

I have recently been treated for a serious infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 days

1 visit (in-person)

Treatment

Participants receive a single IV infusion of autologous BMMNC or placebo within 48 hours of injury

2 days

1 visit (in-person)

Initial Monitoring

Participants are monitored for infusion-related toxicity and complications

2 weeks

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 1, 6, and 12 months post-injury

Treatment Details

Interventions

• Autologous BMMNC Infusion
• Placebo Infusion

Trial Overview The trial is testing whether an infusion of the patient's own bone marrow mononuclear cells (BMMNC) can help preserve brain structure and improve cognitive/functional outcomes after TBI compared to a placebo infusion. It also looks at inflammation response and long-term safety.

Participant Groups

Group I: Autologous BMMNC Infusion Experimental Treatment 1 Intervention

Subjects randomized to the treatment group will undergo a bone marrow harvest and then receive an autologous infusion of BMMNC's starting with the lowest dose (6 x 10\^6 cells/kg body weight) and progressing to the high dose of 9 x 10\^6 cells/kg body weight using a Bayesian adaptive dose escalation design.

Group II: Placebo Infusion Placebo Group 1 Intervention

Subjects randomized to the placebo control group will undergo a "sham" bone marrow harvest.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+