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
- Registration Number
- NCT04063215
- Lead Sponsor
- Hope Biosciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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) -
-
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
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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
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participation in a concurrent interventional study
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inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments
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unwilling or unable to return for follow-up study visits -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HB-adMSC HB-adMSCs HB-adMSCs will be infused three times over a six week period, spaced 14 days apart
- Primary Outcome Measures
Name Time Method Potassium 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) clinical lab evaluation of potassium in the blood (mmol/L)
Glucose 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) clinical lab evaluation of level of glucose in the blood (mg/dL)
Creatinine 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) clinical evaluation of creatinine in blood (mg/dL)
Alkaline phosphatase 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) clinical evaluation of alkaline phosphatase (ALP) in blood (IU/L)
Calcium 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) clinical lab evaluation of level of calcium in the blood (mg/dL)
Albumin 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) clinical lab evaluation of level of albumin in the blood (g/dL)
Total Protein 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) clinical lab evaluation of total protein in the blood (g/dL)
Sodium 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) clinical lab evaluation of total sodium in the blood (mmol/L)
Total carbon dioxide 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) clinical lab evaluation of total carbon dioxide in the blood (mmol/L)
Chloride 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) clinical lab evaluation of chloride in the blood (mmol/L)
Red blood cell 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) clinical evaluation of red blood cells (RBC) in blood (x 10\^6/uL)
BUN 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) clinical evaluation of blood urea nitrogen (BUN) (mg/dL)
Aspartate aminotransferase 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) clinical evaluation of aspartate aminotransferase (AST) in blood (IU/L)
Total Bilirubin 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) clinical evaluation of total bilirubin in blood (mg/dL)
Hemoglobin 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) clinical evaluation of hemoglobin in blood (g/dL)
Mean corpuscular hemoglobin concentration 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) clinical evaluation of mean corpuscular hemoglobin concentration (MCHC) in blood (g/dL)
Red cell distribution width 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) clinical evaluation of red cell distribution width (RDW) in blood (%)
Alanine aminotransferase 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) clinical evaluation of alanine aminotransferase (ALT) in blood (IU/L)
Hematocrit 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) clinical evaluation of hematocrit in blood (%)
Mean corpuscular volume 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) clinical evaluation of mean corpuscular volume (MCV) in blood (fL)
Lymphs 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) clinical evaluation of lymphocytes in blood (%)
Monocytes 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) clinical evaluation of monocytes in blood (%)
White blood cell 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) clinical evaluation of white blood cells (WBC) in blood (x 10\^3/uL)
Mean corpuscular hemoglobin 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) clinical evaluation of mean corpuscular hemoglobin (MCH) in blood (pg)
Neutrophils 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) clinical evaluation of neutrophils in blood (%)
Eos 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) clinical evaluation of eosinophils in blood (%)
Basos 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) clinical evaluation of basophils in blood (%)
Absolute Neutrophils 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) clinical evaluation of absolute neutrophils in blood (x 10\^3/uL)
Immature Granulocytes 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) clinical evaluation of immature granulocytes in blood (%)
Absolute Immature Granulocytes 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) clinical evaluation of absolute immature granulocytes in blood (x 10\^3/uL)
Absolute Lymphs 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) clinical evaluation of absolute lymphocytes in blood (x 10\^3/uL)
Absolute monocytes 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) clinical evaluation of absolute monocytes in blood (x 10\^3/uL)
Absolute Eos 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) clinical evaluation of absolute eosinophils in blood (x 10\^3/uL)
Absolute Basos 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) clinical evaluation of absolute basophils in blood (x 10\^3/uL)
Platelets 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) clinical evaluation of platelets in blood (x 10\^3/uL)
Prothrombin Time 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) clinical evaluation of time for blood to coagulate (seconds)
Urine Pregnancy 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) clinical evaluation of human chorionic gonadotropin (hCG) in urine (positive/negative)
INR 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) clinical evaluation of international normalized ratio of blood coagulation (no unit)
- Secondary Outcome Measures
Name Time Method Whole brain MRI Baseline, change from baseline at 6 months post-infusion DTI to assess macro- and micro-structural properties
PET/DT-MRI Baseline, change from baseline at 6 months post-infusion \[11C\]ER-176 tracer/label to identify brain proteins associated with neuroinflammatory response regulation
Glasgow Outcome Score Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion Dichotomized-Glasgow Outcomes Score (GOSE) to evaluate affect, functional outcome, and neuropsychological function
Galveston Orientation and Amnesia Test Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion Galveston Orientation and Amnesia Test (GOAT) evaluation of cognition
TBI Quality of Life Questionnaires (TBI-QOL SF) Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion Rivermead Post-Concussion Symptoms Questionnaire (RPSQ) evaluation to identify presence and severity of concussive symptoms
Automated Neuropsychological Assessment Metrics Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion Automated Neuropsychological Assessment Metrics (ANAM) evaluation of attention, concentration, reaction time, memory, processing speed, and decision-making
Verbal Selective Reminding Test Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion Verbal Selective Reminding Test (VSRT) to evaluate verbal learning and memory
Verbal Fluency Test Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion Verbal Fluency Test (VFT) to evaluate vocabulary size, lexical access speed, updating, and inhibition ability
Stroop Baseline, change from baseline at Imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion Stroop to evaluate selective attention and cognitive flexibility
Interleukin 1-alpha Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion measure IL-1α via a bead-based, flow cytometric ELISA for the cytokines
Interleukin 4 Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion measure IL-4 via a bead-based, flow cytometric ELISA for the cytokines
Tumor necrosis factor alpha Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion measure TNFα via a bead-based, flow cytometric ELISA for the cytokines
Interleukin 6 Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion measure IL-6 via a bead-based, flow cytometric ELISA for the cytokines
Interleukin 10 Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion measure IL-10 via a bead-based, flow cytometric ELISA for the cytokines
Albumin Baseline, change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion measure concentration of albumin via BCG immunochemical analysis
Trial Locations
- Locations (1)
Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)
🇺🇸Houston, Texas, United States