Status:
COMPLETED
A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy
Lead Sponsor:
Hope Biosciences LLC
Collaborating Sponsors:
The University of Texas Health Science Center, Houston
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and...
Detailed Description
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on global gray and/or white matter, as well as structural integrity of GM and WM regions of inte...
Eligibility Criteria
Inclusion
- adults between 18 and 55 years of age
- documented head injury with functional neurological damage to the central nervous system 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
- ability to obtain consent from the subject of their legally authorized representative (LAR)
- ability to speak English or Spanish \*required for validated neurocognitive outcome testing) -
Exclusion
- known history of:
- intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
- recently treated infection,
- renal disease or altered renal function (screening serum creatinine \> 1.5 mg/dL),
- 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),
- HIV+,
- chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
- acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation,
- bleeding disorders 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.
- Normal brain CT/MRI exam
- Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam
- 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 child bearing 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
- participation in a concurrent interventional study
- inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments
- unwilling or unable to return for follow-up study visits -
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04063215
Start Date
January 1 2020
End Date
October 25 2024
Last Update
September 29 2025
Active Locations (1)
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1
Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)
Houston, Texas, United States, 77030