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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04063215
• Other study ID #: HBTBI01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Hope Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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:

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 -

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Biological:
• HB-adMSCs
Hope Biosciences autologous adipose-derived mesenchymal stem cells

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)	Houston	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	clinical lab evaluation of level of glucose in the blood (mg/dL)	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)
Primary	Calcium	clinical lab evaluation of level of calcium in the blood (mg/dL)	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)
Primary	Albumin	clinical lab evaluation of level of albumin in the blood (g/dL)	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)
Primary	Total Protein	clinical lab evaluation of total protein in the blood (g/dL)	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)
Primary	Sodium	clinical lab evaluation of total sodium in the blood (mmol/L)	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)
Primary	Total carbon dioxide	clinical lab evaluation of total carbon dioxide in the blood (mmol/L)	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)
Primary	Potassium	clinical lab evaluation of potassium in the blood (mmol/L)	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)
Primary	Chloride	clinical lab evaluation of chloride in the blood (mmol/L)	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)
Primary	BUN	clinical evaluation of blood urea nitrogen (BUN) (mg/dL)	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)
Primary	Creatinine	clinical evaluation of creatinine in blood (mg/dL)	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)
Primary	Alkaline phosphatase	clinical evaluation of alkaline phosphatase (ALP) in blood (IU/L)	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)
Primary	Alanine aminotransferase	clinical evaluation of alanine aminotransferase (ALT) in blood (IU/L)	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)
Primary	Aspartate aminotransferase	clinical evaluation of aspartate aminotransferase (AST) in blood (IU/L)	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)
Primary	Total Bilirubin	clinical evaluation of total bilirubin in blood (mg/dL)	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)
Primary	White blood cell	clinical evaluation of white blood cells (WBC) in blood (x 10^3/uL)	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)
Primary	Red blood cell	clinical evaluation of red blood cells (RBC) in blood (x 10^6/uL)	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)
Primary	Hemoglobin	clinical evaluation of hemoglobin in blood (g/dL)	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)
Primary	Hematocrit	clinical evaluation of hematocrit in blood (%)	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)
Primary	Mean corpuscular volume	clinical evaluation of mean corpuscular volume (MCV) in blood (fL)	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)
Primary	Mean corpuscular hemoglobin	clinical evaluation of mean corpuscular hemoglobin (MCH) in blood (pg)	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)
Primary	Mean corpuscular hemoglobin concentration	clinical evaluation of mean corpuscular hemoglobin concentration (MCHC) in blood (g/dL)	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)
Primary	Red cell distribution width	clinical evaluation of red cell distribution width (RDW) in blood (%)	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)
Primary	Neutrophils	clinical evaluation of neutrophils in blood (%)	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)
Primary	Lymphs	clinical evaluation of lymphocytes in blood (%)	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)
Primary	Monocytes	clinical evaluation of monocytes in blood (%)	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)
Primary	Eos	clinical evaluation of eosinophils in blood (%)	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)
Primary	Basos	clinical evaluation of basophils in blood (%)	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)
Primary	Absolute Neutrophils	clinical evaluation of absolute neutrophils in blood (x 10^3/uL)	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)
Primary	Absolute Lymphs	clinical evaluation of absolute lymphocytes in blood (x 10^3/uL)	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)
Primary	Absolute monocytes	clinical evaluation of absolute monocytes in blood (x 10^3/uL)	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)
Primary	Absolute Eos	clinical evaluation of absolute eosinophils in blood (x 10^3/uL)	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)
Primary	Absolute Basos	clinical evaluation of absolute basophils in blood (x 10^3/uL)	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)
Primary	Immature Granulocytes	clinical evaluation of immature granulocytes in blood (%)	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)
Primary	Absolute Immature Granulocytes	clinical evaluation of absolute immature granulocytes in blood (x 10^3/uL)	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)
Primary	Platelets	clinical evaluation of platelets in blood (x 10^3/uL)	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)
Primary	Prothrombin Time	clinical evaluation of time for blood to coagulate (seconds)	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)
Primary	INR	clinical evaluation of international normalized ratio of blood coagulation (no unit)	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)
Primary	Urine Pregnancy	clinical evaluation of human chorionic gonadotropin (hCG) in urine (positive/negative)	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	Whole brain MRI	DTI to assess macro- and micro-structural properties	Baseline, change from baseline at 6 months post-infusion
Secondary	PET/DT-MRI	[11C]ER-176 tracer/label to identify brain proteins associated with neuroinflammatory response regulation	Baseline, change from baseline at 6 months post-infusion
Secondary	Glasgow Outcome Score	Dichotomized-Glasgow Outcomes Score (GOSE) to evaluate affect, functional outcome, and neuropsychological function	Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Galveston Orientation and Amnesia Test	Galveston Orientation and Amnesia Test (GOAT) evaluation of cognition	Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Rivermead Post-Concussion Symptoms Questionnaire	Rivermead Post-Concussion Symptoms Questionnaire (RPSQ) evaluation to identify presence and severity of concussive symptoms	Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Automated Neuropsychological Assessment Metrics	Automated Neuropsychological Assessment Metrics (ANAM) evaluation of attention, concentration, reaction time, memory, processing speed, and decision-making	Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Verbal Selective Reminding Test	Verbal Selective Reminding Test (VSRT) to evaluate verbal learning and memory	Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Verbal Fluency Test	Verbal Fluency Test (VFT) to evaluate vocabulary size, lexical access speed, updating, and inhibition ability	Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Stroop	Stroop to evaluate selective attention and cognitive flexibility	Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Secondary	Interleukin 1-alpha	measure IL-1a via a bead-based, flow cytometric ELISA for the cytokines	Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Interleukin 4	measure IL-4 via a bead-based, flow cytometric ELISA for the cytokines	Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Tumor necrosis factor alpha	measure TNFa via a bead-based, flow cytometric ELISA for the cytokines	Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Interleukin 6	measure IL-6 via a bead-based, flow cytometric ELISA for the cytokines	Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Interleukin 10	measure IL-10 via a bead-based, flow cytometric ELISA for the cytokines	Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion
Secondary	Albumin	measure concentration of albumin via BCG immunochemical analysis	Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion