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RecruitingPhase 2

Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "This study is a prospective, randomized, double-blind, placebo-controlled Phase 2a study of three infusions of autologous HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) (2 x 10\^8 total cells per dose) administered over a 6 week period with 14 day intervals between infusions."
  • "Subjects will be monitored and assessed for infusion related toxicity for at least 1 hour after the infusion and by telephone 24hr. after each infusion."
  • "Safety assessments will be conducted at the study follow-up clinic visits 6 and 12 months, and 2 years (telephone call) after the last HB-adMSC (Hope Biosciences adipose-derived mesenchymal stem cells) infusion, or more frequently if infusion related adverse events are suspected."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and possible benefits of stem cells taken from a person's own fat and given through a vein. It is for adults ages 18–55 with a long-term brain injury caused by a hit to the head. Researchers will study changes in the brain, thinking skills, daily tasks, and brain inflammation (swelling).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–55 years old.
  • You have documented brain or nerve damage from a hit to the head that affects how you function and is unlikely to improve with standard care.
  • Your score is above 2 and no higher than 6 on the GOS-E, a scale that measures recovery after brain injury.
  • Your injury began or was diagnosed more than 6 months ago, but no more than 20 years ago.
  • You or your legal representative can give consent to join.
  • You can speak English or Spanish for thinking and memory tests.

Who can't join

  • You have an intellectual disability or an uncontrolled mental health condition that could affect testing, or drug or alcohol dependence that the study doctor believes would prevent participation.
  • You have a recently treated infection, cancer, a weak immune system, or a positive test for HIV, hepatitis B, hepatitis C, or syphilis.
  • You have kidney or liver disease, kidney or liver test results outside the study's limits, or lung disease that needs substantial medicine or extra oxygen.
  • You have a bleeding disorder, low blood platelets (cells that help stop bleeding), sensitivity to heparin, Lovenox, or pork products, or a mechanical heart valve.
  • Your brain CT or MRI scan is normal; you have a complete spinal cord injury; you have a genetic or body-chemistry disorder linked to your nerve or brain condition; or you have planned spinal anesthesia or a spinal tap. Other health problems that raise study risks may also prevent you from joining.
  • You have had stem cell treatment, gene therapy, or cell therapy, or you are also in a study testing a drug or device.
  • You test positive for pregnancy at screening, or you are unwilling to use acceptable birth control during the study.
  • You cannot complete or cooperate with the required scans and tests, have metal implants that prevent the required MRI, have vision problems that cannot be corrected and prevent testing, or cannot or will not return for follow-up visits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Adults between 18 and 55 years of age. 2. Documented functional neurological damage to the central nervous system from blunt force head trauma unlikely to improve with present standard of care approaches. 3. A Glasgow Outcome Scale-Extended (GOS-E) score \> 2 and ≤ 6. 4. Onset or diagnosis of the injury or disease process greater than 6 months and ≤ 20 years. 5. Ability to obtain consent from the subject or their legally authorized representative (LAR). 6. Ability to verbally communicate in English or Spanish (required for validated neurocognitive outcome testing). Exclusion Criteria: 1. Known history of: 1. 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, 2. recently treated infection, 3. renal disease or altered renal function (screening eGFR \< 60 mL/min/1.73m2), 4. hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL), 5. cancer, 6. immunosuppression (screening WBC \< 3, 000 cells/ml), 7. Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis, 8. chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment/participation in the study, 9. acute or chronic lung disease requiring significant medication/oxygen supplementation, 10. bleeding disorders, thrombocytopenia, including immune-mediated heparin-induced thrombocytopenia, 11. known sensitivity to heparin, Lovenox, and pork products, 12. individuals with mechanical prosthetic heart valves, 13. individuals who have received a stem cell treatment, gene or cellular therapy. 2. Normal brain CT/MRI exam. 3. Planned epidural or spinal anesthesia, or undergoing spinal puncture, complete spinal cord injury. 4. Diagnosed with a genetic or metabolic disorder related to the neurologic condition. 5. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation. 6. 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. 7. Concurrent participation in interventional drug or device study. 8. Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments. 9. Metal implants including baclofen pumps that would preclude DT-MRI. 10. Unwilling or unable to return for the follow-up study visits. 11. Uncorrectable vision impairment that will prevent completion of neurocognitive tests require visual processing.

Study sites (2)

TX