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New treatment option for Traumatic Brain Injury
Official title Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
ClinicalTrials.gov ID: NCT05951777
What this study is testing
What is Autologous HB-adMSCs?
Autologous HB-adMSCs is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for traumatic brain injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Adults between 18 and 55 years of age.
- Documented functional neurological damage to the central nervous system from blunt force head trauma unlikely to improve with present standard of...
- A Glasgow Outcome Scale-Extended (GOS-E) score \> 2 and ≤ 6.
- Onset or diagnosis of the injury or disease process greater than 6 months and ≤ 20 years.
- Ability to obtain consent from the subject or their legally authorized representative (LAR).
You likely can't join if
- Known history of:
- intellectual deficiency or uncontrolled psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, or at the...
- recently treated infection,
- renal disease or altered renal function (screening eGFR \< 60 mL/min/1.73m2),
- hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL),
- cancer,
See the full eligibility criteria
- Adults between 18 and 55 years of age.
- Documented functional neurological damage to the central nervous system from blunt force head trauma unlikely to improve with present standard of care approaches.
- A Glasgow Outcome Scale-Extended (GOS-E) score \> 2 and ≤ 6.
- Onset or diagnosis of the injury or disease process greater than 6 months and ≤ 20 years.
- Ability to obtain consent from the subject or their legally authorized representative (LAR).
- Ability to verbally communicate in English or Spanish (required for validated neurocognitive outcome testing).
- Known history of:
- intellectual deficiency or uncontrolled psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, or at the discretion of the PI,
- recently treated infection,
- renal disease or altered renal function (screening eGFR \< 60 mL/min/1.73m2),
- hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL),
- cancer,
- immunosuppression (screening WBC \< 3, 000 cells/ml),
- Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis,
- chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment/participation in the study,
- acute or chronic lung disease requiring significant medication/oxygen supplementation,
- bleeding disorders, thrombocytopenia, including immune-mediated heparin-induced thrombocytopenia,
- known sensitivity to heparin, Lovenox, and pork products,
- individuals with mechanical prosthetic heart valves,
- individuals who have received a stem cell treatment, gene or cellular therapy.
- Normal brain CT/MRI exam.
- Planned epidural or spinal anesthesia, or undergoing spinal puncture, complete spinal cord injury.
- Diagnosed with a genetic or metabolic disorder related to the neurologic condition.
- Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
- For women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study.
- Concurrent participation in treatment drug or device study.
- Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
- Metal implants including baclofen pumps that would preclude DT-MRI.
- Unwilling or unable to return for the follow-up study visits.
- Uncorrectable vision impairment that will prevent completion of neurocognitive tests require visual processing.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.