Clinical Trials/NCT05951777

NCT05951777

Recruiting

Phase 2

Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Hope Biosciences LLC2 sites in 1 country51 target enrollmentApril 16, 2024

ConditionsTraumatic Brain Injury

InterventionsAutologous HB-adMSCs Normal Saline

Overview

Phase: Phase 2
Intervention: Autologous HB-adMSCs
Conditions: Traumatic Brain Injury
Sponsor: Hope Biosciences LLC
Enrollment: 51
Locations: 2
Primary Endpoint: Absolute Neutrophils
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.

Detailed Description

This study is a prospective, randomized, double-blind, placebo-controlled Phase 2a study of three infusions of autologous HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) (2 x 10\^8 total cells per dose) administered over a 6 week period with 14 day intervals between infusions. Subjects will be monitored and assessed for infusion related toxicity for at least 1 hour after the infusion and by telephone 24hr. after each infusion. Safety assessments will be conducted at the study follow-up clinic visits 6 and 12 months, and 2 years (telephone call) after the last HB-adMSC (Hope Biosciences adipose-derived mesenchymal stem cells) infusion, or more frequently if infusion related adverse events are suspected.

Registry

clinicaltrials.gov

Start Date

April 16, 2024

End Date

December 1, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hope Biosciences LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults between 18 and 55 years of age.
•Documented functional neurological damage to the central nervous system from closed head trauma that is unlikely to improve with present standard of care approaches.
•A Glasgow Outcome Scale-Extended (GOS-E) score \>2 and ≤
•Onset or diagnosis of the injury or disease process greater than 6 months and \<= 20 years.
•Ability to obtain consent from the subject or their legally authorized representative (LAR).
•Ability to verbally communicate in English or Spanish (required for validated neurocognitive outcome testing).

Exclusion Criteria

•Known history of:
•intellectual deficiency or uncontrolled psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, or at the discretion of the PI,
•recently treated infection,
•renal disease or altered renal function (screening eGFR \< 60 mL/min/1.73m2),
•hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL),
•immunosuppression (screening WBC \< 3, 000 cells/ml),
•Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis,
•chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment,
•acute or chronic lung disease requiring significant medication/oxygen supplementation,
•bleeding disorders including immune-mediated heparin-induced thrombocytopenia,

Arms & Interventions

Treatment

Autologous Adipose Derived Mesenchymal Stem Cells

Intervention: Autologous HB-adMSCs

Placebo

Normal Saline

Intervention: Normal Saline

Outcomes

Primary Outcomes

Absolute Neutrophils

Time Frame: Week 0 (Infusion 1), change from week 0 (Infusion 1) at week 2 (Infusion 2), change from week 0 (Infusion 1) at week 4 (Infusion 3), change from week 0 (Infusion 1) at 6 months post-infusion, change from week 0 (Infusion 1) at 1 year post-infusion

clinical evaluation of absolute neutrophils in blood (x 10\^3/uL)

Eosinophils

clinical evaluation of eosinophils in blood (%)

Basophils

clinical evaluation of basophils in blood (%)

Absolute lymphocytes

clinical evaluation of absolute lymphocytes in blood (x 10\^3/uL)

Absolute monocytes

clinical evaluation of absolute monocytes in blood (x 10\^3/uL)

Absolute eosinophils

clinical evaluation of absolute eosinophils in blood (x 10\^3/uL)

Mean corpuscular volume

clinical evaluation of mean corpuscular volume (MCV) in blood (fL)

Glucose

clinical lab evaluation of level of glucose in the blood (mg/dL)

Calcium

clinical lab evaluation of level of calcium in the blood (mg/dL) clinical lab evaluation of level of calcium in the blood (mg/dL) clinical lab evaluation of level of calcium in the blood (mg/dL)

Albumin

clinical lab evaluation of level of albumin in the blood (g/dL)

Total Protein

clinical lab evaluation of total protein in the blood (g/dL)

Sodium

clinical lab evaluation of total sodium in the blood (mmol/L)

Total Bilirubin

clinical evaluation of total bilirubin in blood (mg/dL)

White blood cell

clinical evaluation of white blood cells (WBC) in blood (x 10\^3/uL)

Total carbon dioxide

clinical lab evaluation of total carbon dioxide in the blood (mmol/L)

Potassium

clinical lab evaluation of potassium in the blood (mmol/L)

Chloride

clinical lab evaluation of chloride in the blood (mmol/L)

BUN (blood urea nitrogen)

clinical evaluation of blood urea nitrogen (BUN) (mg/dL)

Creatinine

clinical evaluation of creatinine in blood (mg/dL

Alkaline phosphatase

clinical evaluation of alkaline phosphatase (ALP) in blood (IU/L)

Alanine aminotransferase

clinical evaluation of alanine aminotransferase (ALT) in blood (IU/L)

Aspartate aminotransferase

clinical evaluation of aspartate aminotransferase (AST) in blood (IU/L)

Red blood cell

clinical evaluation of red blood cells (RBC) in blood (x 10\^6/uL)

Hemoglobin

clinical evaluation of hemoglobin in blood (g/dL)

Hematocrit

clinical evaluation of hematocrit in blood (%)

Mean corpuscular hemoglobin

clinical evaluation of mean corpuscular hemoglobin (MCH) in blood (pg)

Mean corpuscular hemoglobin concentration

clinical evaluation of mean corpuscular hemoglobin concentration (MCHC) in blood (g/dL)

Red cell distribution width

clinical evaluation of red cell distribution width (RDW) in blood (%)

Neutrophils

clinical evaluation of neutrophils in blood (%)

Lymphocytes

clinical evaluation of lymphocytes in blood (%)

Monocytes

clinical evaluation of monocytes in blood (%)

Absolute basophils

clinical evaluation of absolute basophils in blood (x 10\^3/uL)

Immature Granulocytes

clinical evaluation of immature granulocytes in blood (%)

Absolute Immature Granulocytes

clinical evaluation of absolute immature granulocytes in blood (x 10\^3/uL)

Platelets

clinical evaluation of platelets in blood (x 10\^3/uL)

Prothrombin Time

clinical evaluation of time for blood to coagulate (seconds)

INR (international normalized ratio)

clinical evaluation of international normalized ratio of blood coagulation (no unit)

Urine Pregnancy (if applicable)

clinical evaluation of human chorionic gonadotropin (hCG) in urine (positive/negative)

Secondary Outcomes

Whole brain MRI (Magnetic resonance imaging)(Baseline, change from baseline at 6 months post-infusion)
PET/DT-MRI (positron emission tomography/Diffusion tensor-Magnetic resonance imaging)(Baseline, change from baseline at 6 months post-infusion)
Glasgow Outcome Scale - Extended(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
Disability Rating Scale(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
Behavior Rating of Executive Functions-Adult(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
TBI (Traumatic Brain Injury) Quality of Life Questionnaires(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
Brief Symptom Inventory 18(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
NIH Toolbox - Pattern Comparison Processing Speed Test(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
NIH Toolbox - Dimensional Change Card Sort Test(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
NIH Toolbox - Picture Vocabulary Test(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
NIH Toolbox - List Sorting Working Memory Test(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
NIH Toolbox - Flanker Inhibitory Control and Attention Test(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
NIH Toolbox - 9-hole Pegboard Dexterity Test(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
Rey Auditory Verbal Learning Test(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
Verbal Fluency(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
Interleukin 10(Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion)
Wechsler Adult Intelligence Scale - IV: Processing Speed Index(Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion)
Plasma cytokines(Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion)
Interleukin 1-alpha(Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion)
Interleukin 4(Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion)
Tumor necrosis factor alpha(Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion)
Interleukin 6(Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion)
Albumin(Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion)