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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months. post head injury
Awards & highlights
Study Summary
This trialundefined
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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 55 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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).
+4 moreTrial 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.
Find a Location
Who is running the clinical trial?
U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
245,122 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,157 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,940 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a head injury without an open wound.I have a known history of neurological issues.I am on medication for seizures.I have recently been treated for a serious infection.I am between 18 and 55 years old.I can speak English or Spanish.I am HIV positive.I do not have low blood pressure or need medicine to maintain my blood pressure at screening.I have lung bruises shown on an X-ray and low oxygen levels due to an injury.I have a spinal cord injury confirmed by imaging or doctor's exam.I can legally consent and undergo a procedure within 48 hours of my injury.My kidney function is reduced with a creatinine level over 1.5 mg/dL.Your Glasgow Coma Score (GCS) is between 3 and 8, which is a measure of how alert you are.I can get consent and undergo a procedure within 48 hours of my injury.I have a severe injury to an organ in my abdomen or pelvis confirmed by imaging.I have a mental health condition that may affect cognitive or behavioral assessments.I have an unstable pelvic fracture that makes bone marrow procedures risky.I am not willing to come back for follow-up visits.My liver isn't working properly (high enzyme levels or bilirubin).I have a history of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous BMMNC Infusion
- Group 2: Placebo Infusion
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would I qualify to be a subject in this research?
"This trial is for 55 patients with brain injuries aged 18 to 55. Most notably, applicants must meet the following criteria: Adults 18 to 55 years of age on the day of injury, Non-penetrating closed head trauma., Ability to obtain legally authorized representative consent for participation and complete the BMMNC/Sham harvest and cell/placebo infusion within 48 hours of the initial injury., Glasgow Coma Score between (GCS) between 3 and 8, (best un-medicated post-resuscitation score during screening)."
Answered by AI
Can new patients still join this clinical trial?
"According to information on clinicaltrials.gov, this study is not looking for any more patients at the moment. The trial was originally posted on November 21st, 2016 and was last edited on August 1st, 2022. There are other 945 trials that are currently enrolling participants if you're interested in taking part in a clinical trial."
Answered by AI
Does the FDA give its stamp of approval to Autologous BMMNC Infusion?
"While Phase 2 trials don't offer much data on efficacy, the available evidence suggests that Autologous BMMNC Infusion is safe."
Answered by AI
Are people aged 45 or older being recruited for this trial?
"This study is looking for participants who are younger than 55 and have already reached the age of majority."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
Maine
How old are they?
18 - 65
What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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