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Stem Cell Therapy

Stem Cell Therapy for Traumatic Brain Injury

Phase 2

Waitlist Available

Led By Charles S Cox, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults 18 to 55 years of age on the day of injury

Be between 18 and 65 years old

Must not have

Known history of neurologic impairment and/or deficit

Known history of seizure disorder requiring anti-convulsant therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months. post head injury

Summary

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Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the infusion process itself such as discomfort or pain at injection site, infection risk from cell harvest procedure, allergic reactions or body's response to infused cells which could vary widely among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known history of neurological issues.

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I am on medication for seizures.

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I am HIV positive.

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I do not have low blood pressure or need medicine to maintain my blood pressure at screening.

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I have lung bruises shown on an X-ray and low oxygen levels due to an injury.

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I have a spinal cord injury confirmed by imaging or doctor's exam.

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My kidney function is reduced with a creatinine level over 1.5 mg/dL.

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I have a severe injury to an organ in my abdomen or pelvis confirmed by imaging.

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I have a mental health condition that may affect cognitive or behavioral assessments.

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I am not willing to come back for follow-up visits.

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My liver isn't working properly (high enzyme levels or bilirubin).

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I have a history of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months. post head injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months. post head injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months. post head injury for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Macro and micro structural properties of grey matter (GM) and white matter (WM) regions will measured using high-resolution anatomical MRI and diffusion tensorm imaging and comparisons made between groups.

Secondary study objectives

Brain imaging measures of GM and WM structural integrity will be compared to functional and neurocognitive scores and comparisons made between groups.

Compare neuro-inflammatory biomarkers between groups..

Determine if microglial activation is associated with TBI and can be accurately measured with brain PET and DT-MRI imaging when compared to PET imaging data from healthy volunteers (enrolled under a different protocol).

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Autologous BMMNC InfusionExperimental Treatment1 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 InfusionPlacebo Group1 Intervention

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

0 / 13Eligibility criteria met