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Stem Cell Therapy

Stem Cell Therapy for Traumatic Brain Injury

Phase 2
Recruiting
Led By Charles S Cox, MD
Research Sponsored by Hope Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults between 18 and 55 years of age
Documented functional neurological damage to the central nervous system from closed head trauma that is unlikely to improve with present standard of care approaches
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Awards & highlights

Study Summary

This trial tests if stem cells can help adults with brain injuries or lack of oxygen to the brain heal better.

Who is the study for?
This trial is for adults aged 18-55 with chronic traumatic brain injury, who can consent and communicate in English or Spanish. They should have documented neurological damage unlikely to improve with current treatments and a moderate disability level (GOS-E score >2 and ≤6). Excluded are those with intellectual deficits, psychiatric conditions, other serious health issues, pregnancy, participation in other drug/device trials, inability to undergo PET/DT-MRI tests or follow-up visits, recent infections, HIV+, certain allergies or diseases affecting organs like the liver and kidneys.Check my eligibility
What is being tested?
The study is testing the safety and potential benefits of HB-adMSCs (stem cells derived from one's own fat tissue) given through an IV to improve brain structure and function after a traumatic brain injury. It compares this treatment against a saline solution placebo. The focus is on how well patients recover cognitively and structurally from their injuries.See study design
What are the potential side effects?
While specific side effects aren't listed for HB-adMSCs since it's under investigation, common stem cell therapy risks include infection at injection site, immune system reactions causing fever or chills; however individual experiences may vary.

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.
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I have lasting brain damage from a head injury that likely won't get better with current treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Immature Granulocytes
Absolute Neutrophils
Absolute basophils
+34 more
Secondary outcome measures
Albumin
Behavior Rating of Executive Functions-Adult
Brain Injury Functional Outcome Measure
+20 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Autologous Adipose Derived Mesenchymal Stem Cells
Group II: PlaceboPlacebo Group1 Intervention
Normal Saline

Find a Location

Who is running the clinical trial?

Hope BiosciencesLead Sponsor
23 Previous Clinical Trials
275 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
903 Previous Clinical Trials
320,926 Total Patients Enrolled
Charles S Cox, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
4 Previous Clinical Trials
81 Total Patients Enrolled

Media Library

Autologous Adipose Derived Mesenchymal Stem Cells (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05951777 — Phase 2
Traumatic Brain Injury Research Study Groups: Treatment, Placebo
Traumatic Brain Injury Clinical Trial 2023: Autologous Adipose Derived Mesenchymal Stem Cells Highlights & Side Effects. Trial Name: NCT05951777 — Phase 2
Autologous Adipose Derived Mesenchymal Stem Cells (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05951777 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment enrolling participants of a young age?

"This clinical trial is inviting applications from patients aged 18 to 55 years."

Answered by AI

What security measures are in place to ensure the safety of those who receive this therapy?

"As this is a Phase 2 trial, with data showing some safety but no efficacy, the treatment was given an evaluation score of 2."

Answered by AI

Are applications for this experiment open at the present?

"According to the clinicaltrials.gov website, this particular medical trial opened for patient enrollment on December 1st 2023 and has since been closed off from further recruitment efforts. Despite not being able to join this study, there are still 954 other trials actively recruiting patients at present."

Answered by AI

What criteria must participants meet to join this research initiative?

"Aspiring enrollees should have a diagnosis of traumatic brain injury and be between 18-55 years old. A maximum of 51 participants will be accepted for this trial."

Answered by AI

What is the primary goal of this clinical investigation?

"The primary outcome evaluated over a week 0 (Infusion 1) - one year post-infusion time frame is the calcium level. Secondary outcomes include PET/DT-MRI, which uses [11C]ER-176 to look at neuroinflammatory response regulation; Glasgow Outcome Scale - Extended with higher scores representing better results; and Brain injury Functional Outcome Measure for global functioning assessment."

Answered by AI
~34 spots leftby Dec 2026