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

Hope Biosciences LLC

Status and phase: Completed; Phase 2; Phase 1

Conditions: Traumatic Brain Injury

Treatments: Biological: HB-adMSCs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04063215

HBTBI01

Details and patient eligibility

About

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 chronic neurological injury in adults.

Full 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 interest in the corpus callous and corticospinal tracts as measured by fractional anisotropy (FA) and mean diffusivity (MD) in specific regions known to correlate with specific neurocognitive deficits in patients after neurological injury.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. adults between 18 and 55 years of age
2. documented head injury with functional neurological damage to the central nervous system 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
5. ability to obtain consent from the subject of their legally authorized representative (LAR)
6. ability to speak English or Spanish *required for validated neurocognitive outcome testing) -

Exclusion criteria

1. known history of:

   1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
   2. recently treated infection,
   3. renal disease or altered renal function (screening serum creatinine > 1.5 mg/dL),
   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. HIV+,
   8. chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
   9. acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation,
   10. bleeding disorders 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.

2. Normal brain CT/MRI exam

3. Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam

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 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

7. participation in a concurrent interventional study

8. inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments

9. unwilling or unable to return for follow-up study visits -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

HB-adMSC

Experimental group

Description:

HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)

Treatment:

Biological: HB-adMSCs