Stem Cell Therapy for Traumatic Brain Injury

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stem cell therapy can aid recovery from severe traumatic brain injuries. Researchers are testing if an infusion of a patient’s own bone marrow cells (Autologous BMMNC Infusion) can protect brain structure and enhance thinking and functioning after injury. The trial includes two groups: one receiving the stem cell treatment and the other a placebo. Individuals who have suffered a severe, non-penetrating head injury and can begin treatment within 48 hours may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have a seizure disorder requiring anti-convulsant therapy, you would be excluded from participating.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using a person's own bone marrow cells is generally safe. In earlier studies, children who received these cells within 48 hours after a severe brain injury experienced no serious side effects. These studies demonstrated that the treatment is feasible and did not cause harm. While these results are encouraging for adults as well, it's important to remember that this treatment remains under investigation.

Overall, current evidence suggests that using a person's own bone marrow cells is well-tolerated, but participating in a study like this helps confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for traumatic brain injury, which typically includes medications to manage symptoms and rehabilitation therapies, Autologous BMMNC Infusion uses a novel approach by utilizing the patient’s own bone marrow-derived stem cells. This treatment is exciting because it aims to promote brain repair and regeneration by delivering a high dose of bone marrow mononuclear cells directly into the body. Researchers are particularly interested in the potential for these cells to enhance recovery by targeting the injury at a cellular level, which is a promising shift from merely managing symptoms to potentially reversing damage.

What evidence suggests that autologous BMMNC infusion might be an effective treatment for traumatic brain injury?

Research has shown that using a person's own bone marrow cells, called BMMNCs, may help treat severe traumatic brain injuries (TBI). In this trial, participants in the experimental arm will receive an autologous BMMNC infusion. One study found that this treatment led to shorter stays in intensive care and improved the structure of white matter, the brain tissue connecting different regions. Other research indicates that BMMNCs can enhance movement abilities and quality of life for people with brain injuries. Early studies suggest these cells help repair brain damage after TBI. Overall, this treatment could improve brain structure and function in those with severe brain injuries. ^{1 2 4 6 7}

Who Is on the Research Team?

Charles S Cox, MD

Principal Investigator

UTHealth McGovern Medical School, Houston, TX

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38181433/

Autologous bone marrow mononuclear cells to treat severe ... Our data show that BMMNC infusion led to: (i) shorter intensive care duration and decreased ICU intensity; (ii) white matter structural ...

2. academic.oup.com academic.oup.com/braincomms/article/7/5/fcaf361/8262499

Autologous bone marrow mononuclear cell administration for ... Intrathecal administration of bone marrow mononuclear cells is safe and effective in improving motor function and quality of life in patients ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01851083

Pediatric Autologous Bone Marrow Mononuclear Cells for ... The investigators hope to determine the effect of intravenous infusion of autologous BMMNCs on brain structure and neurocognitive/functional outcomes after ...

4. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-023-03349-w

Outcomes of autologous bone marrow mononuclear cell ... Intrathecal infusions of autologous bone marrow mononuclear cells are safe and may improve bowel, bladder, and motor function in children with SB.

5. stemcellsjournals.onlinelibrary.wiley.com stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/stem.2538

Treatment of Severe Adult Traumatic Brain Injury Using Bone ... Numerous preclinical studies have shown that autologous bone marrow derived mononuclear cells (BMMNCs) improve outcomes after TBI with a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4351120/

Autologous Bone Marrow Mononuclear Cells Reduce ... Our study evaluates whether pediatric TBI patients receiving intravenous, autologous BMMNCs within 48 hours of injury experienced a reduction in therapeutic ...

7. childrenslearninginstitute.org childrenslearninginstitute.org/blog/autologous-bone-marrow-mononuclear-cells-to-treat-severe-traumatic-brain-injury-in-children/

Autologous Bone Marrow Mononuclear Cells to Treat ... We conclude that autologous BMMNC infusion in children within 48 hours after severe traumatic brain injury is safe and feasible. Our data show ...