Autologous Adipose Derived MSC (HB-adMSC) for Sub-Acute and Chronic Neurological Injury

• Status: Not yet recruiting
• Trial end date: 2020-08-29
• Target enrollment: 24
• Participant gender: All

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 chronic neurological injury in adults.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hope Biosciences
• Collaborator: The University of Texas Health Science Center, Houston

Criteria

Inclusion Criteria:

1. adults between 18 and 55 years of age

2. documented 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:

a) intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, b) recently treated infection, c) renal disease or altered renal function (screening serum creatinine > 1.5 mg/dL), d) hepatic disease or altered liver function (screening SGPT > 150 U/L or T. Bilirubin >1.3 mg/dL), e) cancer, f) immunosuppression (screening WBC < 3, 000 cells/ml), g) HIV+, h) chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study, i) acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation, j) bleeding disorders including immune-mediated heparin-induced thrombocytopenia, k) known sensitivity to heparin, Lovenox, and pork products, l) individuals with mechanical prosthetic heart valves.

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 -