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NCT Number: NCT05951777

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Graft vs Host Disease Hemic and Lymphatic Diseases Hemorrhage Immune System Diseases Immunoproliferative Disorders Intracranial Hemorrhages Lung Diseases Lung Diseases, Obstructive Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston, Houston, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults between 18 and 55 years of age.
  • Documented functional neurological damage to the central nervous system from blunt force head trauma 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 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),
  • cancer,
  • 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/participation in the study,
  • acute or chronic lung disease requiring significant medication/oxygen supplementation,
  • bleeding disorders, thrombocytopenia, 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, gene or cellular therapy.
  • Normal brain CT/MRI exam.
  • Planned epidural or spinal anesthesia, or undergoing spinal puncture, complete spinal cord injury.
  • 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.
  • For women of childbearing 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.
  • Concurrent participation in interventional drug or device study.
  • Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
  • Metal implants including baclofen pumps that would preclude DT-MRI.
  • Unwilling or unable to return for the follow-up study visits.
  • Uncorrectable vision impairment that will prevent completion of neurocognitive tests require visual processing.

Treatment and study plan

Autologous HB-adMSCs

Biological

Hope Biosciences autologous adipose-derived mesenchymal stem cells

normal saline

Drug

Sterile Saline Solution 0.9%

Primary outcomes

  1. Glucose

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

  2. Calcium

    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 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)

  3. Albumin

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

  4. Total Protein

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

  5. Sodium

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

  6. Total carbon dioxide

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

  7. Potassium

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

  8. Chloride

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

  9. BUN (blood urea nitrogen)

    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 blood urea nitrogen (BUN) (mg/dL)

  10. Creatinine

    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 creatinine in blood (mg/dL

  11. Alkaline phosphatase

    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 alkaline phosphatase (ALP) in blood (IU/L)

  12. Alanine aminotransferase

    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 alanine aminotransferase (ALT) in blood (IU/L)

  13. Aspartate aminotransferase

    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 aspartate aminotransferase (AST) in blood (IU/L)

  14. Total Bilirubin

    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 total bilirubin in blood (mg/dL)

  15. White blood cell

    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 white blood cells (WBC) in blood (x 10^3/uL)

  16. Red blood cell

    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 red blood cells (RBC) in blood (x 10^6/uL)

  17. Hemoglobin

    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 hemoglobin in blood (g/dL)

  18. Hematocrit

    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 hematocrit in blood (%)

  19. Mean corpuscular volume

    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 mean corpuscular volume (MCV) in blood (fL)

  20. Mean corpuscular hemoglobin

    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 mean corpuscular hemoglobin (MCH) in blood (pg)

  21. Mean corpuscular hemoglobin concentration

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

  22. Red cell distribution width

    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 red cell distribution width (RDW) in blood (%)

  23. 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 neutrophils in blood (%)

  24. Lymphocytes

    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 lymphocytes in blood (%)

  25. Monocytes

    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 monocytes in blood (%)

  26. Eosinophils

    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 eosinophils in blood (%)

  27. Basophils

    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 basophils in blood (%)

  28. 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)

  29. Absolute lymphocytes

    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 lymphocytes in blood (x 10^3/uL)

  30. Absolute monocytes

    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 monocytes in blood (x 10^3/uL)

  31. Absolute eosinophils

    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 eosinophils in blood (x 10^3/uL)

  32. Absolute basophils

    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 basophils in blood (x 10^3/uL)

  33. Immature Granulocytes

    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 immature granulocytes in blood (%)

  34. Absolute Immature Granulocytes

    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 immature granulocytes in blood (x 10^3/uL)

  35. Platelets

    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 platelets in blood (x 10^3/uL)

  36. Prothrombin Time

    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 time for blood to coagulate (seconds)

  37. INR (international normalized ratio)

    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 international normalized ratio of blood coagulation (no unit)

  38. Urine Pregnancy (if applicable)

    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 human chorionic gonadotropin (hCG) in urine (positive/negative)

Secondary outcomes

  1. Whole brain MRI (Magnetic resonance imaging)

    Time frame: Baseline, change from baseline at 6 months post-infusion

    DTI (Diffusion tensor imaging) to assess macro- and micro-structural properties

  2. PET/DT-MRI (positron emission tomography/Diffusion tensor-Magnetic resonance imaging)

    Time frame: Baseline, change from baseline at 6 months post-infusion

    [11C]ER-176 (a Radioligand for 18-kDa (Translocator Protein)) tracer/label to identify brain proteins associated with neuroinflammatory response regulation

  3. Glasgow Outcome Scale - Extended

    Time frame: Baseline, 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.

    Minimum score = 1 = dead; 2 = vegetative state; 3 = lower severe disability; 4 = upper severe disability; 5 = lower moderate disability; 6 = upper moderate disability; 7 = lower good recovery; Maximum score = 8 = upper good recovery;

    Higher scores indicate better outcome.

  4. Disability Rating Scale

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    Rating of level of arousal, cognitive ability related to activities of daily living, and level of functioning.

  5. Behavior Rating of Executive Functions-Adult

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    Behavior Regulation and Metacognitive Indices assess everyday executive functions

  6. TBI (Traumatic Brain Injury) Quality of Life Questionnaires

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    TBI-QOL SF (Traumatic Brain Injury-Quality of Life Short-Form) measures physical, psychological health, cognitive, and participation outcomes:

    Cognition: minimum raw score = 10, maximum raw score = 50. A higher score represents better functioning.

    Communication/Comprehension: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning.

    Independence: minimum raw score = 8, maximum raw score = 40. A higher score represents better functioning.

    Mobility: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning.

    Satisfaction with Social Roles & Activities: minimum raw score = 10, maximum raw score = 50. A higher score represents better functioning.

    Upper Extremity Function: minimum raw score = 9, maximum raw score = 45. A higher score represents better functioning.

  7. Brief Symptom Inventory 18

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    Brief Symptom Inventory with 18 items contains three six-item scales for somatization, anxiety, depression, and the global Scale Global Severity Index (GSI). Each item is scored either 0 (Not at all), 1 (A little bit), 2 (Moderately), 3 (Quite a bit), 4 (Extremely), or R (Refused).

    The GSI therefore ranges between 0 (minimum) - 72 (maximum) and the three scales range between 0 (minimum) - 24 (maximum).

    Higher scores indicate worse outcome.

  8. NIH Toolbox - Pattern Comparison Processing Speed Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    An assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same.

    Participants are measured based on reaction time (seconds) and accuracy.

  9. NIH Toolbox - Dimensional Change Card Sort Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    An assessment of cognitive flexibility and attention. Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape).

    Participants are measured based on reaction time (seconds) and accuracy.

  10. NIH Toolbox - Picture Vocabulary Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    An assessment of receptive vocabulary administered in a computer-adaptive test (CAT) format. Participants must choose which of four pictures best represents a word presented via audio.

    Participants are measured based on reaction time (seconds) and accuracy.

  11. NIH Toolbox - List Sorting Working Memory Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    Designed to assess working memory (WM). List Sorting is a sequencing task requiring participants to sort and sequence stimuli that are presented visually and auditorily.

    Participants are measured based on accuracy.

  12. NIH Toolbox - Flanker Inhibitory Control and Attention Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    An assessment of inhibitory control and attention. The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it.

    Participants are measured based on reaction time (seconds) and accuracy.

  13. NIH Toolbox - 9-hole Pegboard Dexterity Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    The NIH Toolbox 9-Hole Pegboard Dexterity Test is a simple test of manual dexterity; it records the time required for the participant to accurately place and remove nine plastic pegs into a plastic pegboard. Raw scores are recorded as time in seconds that it takes the participant to complete the task with each hand (a separate score for each - Dominant vs. Non-Dominant Hand).

    Shorter time to complete the task indicates a better outcome. Longer time to complete the task indicates a worse outcome.

  14. Rey Auditory Verbal Learning Test

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    Immediate learning and delayed recall of a word list

  15. Verbal Fluency

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    Attentional control and verbal generativity

  16. Wechsler Adult Intelligence Scale - IV: Processing Speed Index

    Time frame: Baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

    Information processing rate on paper-pencil tasks requiring visual attention. It is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests comprising the Full Scale IQ.

    There are four index scores representing major components of intelligence: Verbal Comprehension Index (VCI); Perceptual Reasoning Index (PRI); Working Memory Index (WMI); Processing Speed Index (PSI)

    Two broad scores are also generated, which can be used to summarize general intellectual abilities: Full Scale IQ (FSIQ), based on the total combined performance of the VCI, PRI, WMI, and PSI; General Ability Index (GAI), based only on the six subtests that comprise the VCI and PRI

    The range of possible WAIS-IV (Wechsler Adult Intelligence Scale - IV) full scale IQs is 45-155. The WAIS-IV computes scaled scores for each individual based exclusively on chronological age.

    Higher score indicates better outcome.

  17. Plasma cytokines

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

    measure plasma cytokines via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines

  18. Interleukin 1-alpha

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

    measure IL-1α (Interleukin 1-alpha) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines

  19. Interleukin 4

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

    measure IL-4 (Interleukin 4) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines

  20. Tumor necrosis factor alpha

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

    measure TNFα (Tumor necrosis factor alpha) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines

  21. Interleukin 6

    Time frame: Baseline imaging (visit #2), 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 (enzyme-linked immunosorbent assay) for the cytokines

  22. Interleukin 10

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

    measure IL-10 (Interleukin 10) via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines

  23. Albumin

    Time frame: Baseline imaging (visit #2), change from baseline at 6 months post-infusion, change from baseline 1 year post-infusion

    measure concentration of albumin via BCG (bromocresol green) immunochemical analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Mendoza, BSN, RN

CONTACT

[email protected]

713-500-8206

Carmen Duron, RN, MHA, BSN

CONTACT

[email protected]

713-500-7395

Sponsors and collaborators

Lead sponsor

Hope Biosciences LLC

Industry

Collaborators

  • The University of Texas Health Science Center, Houston

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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