Clinical trial NCT04063215: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Keywords: severe
hypoxic-ischemic encephalopathy
stroke
intracranial hemorrhage
cerebral palsy
chronic
neurological injury
Lead sponsor: Hope Biosciences
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2019-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, non-randomized study to determine safety and treatment effect of three infusions of HB-adMSC (2 x 10\^8 total cells per dose) in adult patients with sub-acute or chronic neurological injury
Primary purpose: TREATMENT

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 chronic neurological injury in adults.

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 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Glucose
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Calcium
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Albumin
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Total Protein
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Sodium
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Total carbon dioxide
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Potassium
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Chloride
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: BUN
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Creatinine
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Alkaline phosphatase
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Alanine aminotransferase
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Aspartate aminotransferase
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Total Bilirubin
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: White blood cell
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Red blood cell
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Hemoglobin
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Hematocrit
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Mean corpuscular volume
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Mean corpuscular hemoglobin
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Mean corpuscular hemoglobin concentration
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Red cell distribution width
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Neutrophils
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Lymphs
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Monocytes
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Eos
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Basos
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Absolute Neutrophils
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Absolute Lymphs
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Absolute monocytes
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Absolute Eos
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Absolute Basos
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Immature Granulocytes
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Absolute Immature Granulocytes
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Platelets
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Prothrombin Time
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: INR
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
measure: Urine Pregnancy
timeFrame: Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
Secondary outcomes:
measure: Whole brain MRI
timeFrame: Baseline, change from baseline at 6 months post-infusion
measure: PET/DT-MRI
timeFrame: Baseline, change from baseline at 6 months post-infusion
measure: Glasgow Outcome Score
timeFrame: Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
measure: Galveston Orientation and Amnesia Test
timeFrame: Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
measure: TBI Quality of Life Questionnaires (TBI-QOL SF)
timeFrame: Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
measure: Automated Neuropsychological Assessment Metrics
timeFrame: Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
measure: Verbal Selective Reminding Test
timeFrame: Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
measure: Verbal Fluency Test
timeFrame: Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
measure: Stroop
timeFrame: Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
measure: Interleukin 1-alpha
timeFrame: Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
measure: Interleukin 4
timeFrame: Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
measure: Tumor necrosis factor alpha
timeFrame: Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
measure: Interleukin 6
timeFrame: Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
measure: Interleukin 10
timeFrame: Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
measure: Albumin
timeFrame: Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Charles S Cox, MD
role: PRINCIPAL_INVESTIGATOR
References: