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AzTrials

Traumatic Brain InjuryPhase 2NCT05951777

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

A Phase 2 study testing Autologous HB-adMSCs and Normal Saline in people with Traumatic Brain Injury, run by Hope Biosciences LLC at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Autologous HB-adMSCs and Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
2 sitesUnited States
Study dates
16 Apr 2024to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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,
Show all 24Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carmen Duron, RN, MHA, BSN contact

713-500-7395

Maria.Carmen.Duron@uth.tmc.edu

Carla Mendoza, BSN, RN contact

713-500-8206

Carla.D.Wilkerson@uth.tmc.edu

United States2 sites, 2 recruiting

  • Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston

    Houston, Texas, 77030

    Carmen Duron, MHA, BSN, RN, 713-500-7395, Maria.Carmen.Duron@uth.tmc.edu

    Carla Mendoza, BSN, RN, 713-500-8206, Carla.D.Wilkerson@uth.tmc.edu

    Recruiting

  • The University of Texas Health Science at San Antonio

    San Antonio, Texas, 78229

    John Moring, PhD, 210-562-6716, MoringJ@uthscsa.edu

    Sarabeth Fox, 210-415-4792, foxs3@uthscsa.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Autologous HB-adMSCs, Normal Saline
Keywords
severe, intracranial hemorrhage, chronic, neurological injury
Medical subject headings
Brain Injuries, Traumatic, Lymphoma, Follicular, Intracranial Hemorrhages, Bronchiolitis Obliterans Syndrome, Trauma, Nervous System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous HB-adMSCsBiological

    Hope Biosciences autologous adipose-derived mesenchymal stem cells

  • Normal SalineDrug

    Sterile Saline Solution 0.9%

Study groups in NCT05951777
Study groupRoleWhat they receive
TreatmentExperimentalAutologous Adipose Derived Mesenchymal Stem Cells
Receives: Biological: Autologous HB-adMSCs
PlaceboPlacebo comparatorNormal Saline
Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose

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

    Measured: 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

  2. 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)

    Measured: 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

  3. Albumin

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

    Measured: 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

  4. Total Protein

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

    Measured: 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

  5. Sodium

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

    Measured: 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

  6. Total carbon dioxide

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

    Measured: 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

  7. Potassium

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

    Measured: 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

  8. Chloride

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

    Measured: 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

  9. BUN (blood urea nitrogen)

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

    Measured: 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

  10. Creatinine

    clinical evaluation of creatinine in blood (mg/dL

    Measured: 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

  11. Alkaline phosphatase

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

    Measured: 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

  12. Alanine aminotransferase

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

    Measured: 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

  13. Aspartate aminotransferase

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

    Measured: 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

  14. Total Bilirubin

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

    Measured: 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

  15. White blood cell

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

    Measured: 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

  16. Red blood cell

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

    Measured: 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

  17. Hemoglobin

    clinical evaluation of hemoglobin in blood (g/dL)

    Measured: 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

  18. Hematocrit

    clinical evaluation of hematocrit in blood (%)

    Measured: 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

  19. Mean corpuscular volume

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

    Measured: 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

  20. Mean corpuscular hemoglobin

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

    Measured: 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

  21. Mean corpuscular hemoglobin concentration

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

    Measured: 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

  22. Red cell distribution width

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

    Measured: 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

  23. Neutrophils

    clinical evaluation of neutrophils in blood (%)

    Measured: 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

  24. Lymphocytes

    clinical evaluation of lymphocytes in blood (%)

    Measured: 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

  25. Monocytes

    clinical evaluation of monocytes in blood (%)

    Measured: 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

  26. Eosinophils

    clinical evaluation of eosinophils in blood (%)

    Measured: 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

  27. Basophils

    clinical evaluation of basophils in blood (%)

    Measured: 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

  28. Absolute Neutrophils

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

    Measured: 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

  29. Absolute lymphocytes

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

    Measured: 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

  30. Absolute monocytes

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

    Measured: 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

  31. Absolute eosinophils

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

    Measured: 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

  32. Absolute basophils

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

    Measured: 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

  33. Immature Granulocytes

    clinical evaluation of immature granulocytes in blood (%)

    Measured: 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

  34. Absolute Immature Granulocytes

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

    Measured: 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

  35. Platelets

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

    Measured: 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

  36. Prothrombin Time

    clinical evaluation of time for blood to coagulate (seconds)

    Measured: 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

  37. INR (international normalized ratio)

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

    Measured: 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

  38. Urine Pregnancy (if applicable)

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

    Measured: 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

Secondary outcomes (23)

  1. Whole brain MRI (Magnetic resonance imaging)

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

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

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

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

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

  3. Glasgow Outcome Scale - Extended

    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.

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

  4. Disability Rating Scale

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

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

  5. Behavior Rating of Executive Functions-Adult

    Behavior Regulation and Metacognitive Indices assess everyday executive functions

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

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

    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.

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

  7. Brief Symptom Inventory 18

    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.

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

  8. NIH Toolbox - Pattern Comparison Processing Speed Test

    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.

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

  9. NIH Toolbox - Dimensional Change Card Sort Test

    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.

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

  10. NIH Toolbox - Picture Vocabulary Test

    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.

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

  11. NIH Toolbox - List Sorting Working Memory Test

    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.

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

  12. NIH Toolbox - Flanker Inhibitory Control and Attention Test

    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.

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

  13. NIH Toolbox - 9-hole Pegboard Dexterity Test

    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.

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

  14. Rey Auditory Verbal Learning Test

    Immediate learning and delayed recall of a word list

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

  15. Verbal Fluency

    Attentional control and verbal generativity

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

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

    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.

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

  17. Plasma cytokines

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

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

  18. Interleukin 1-alpha

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

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

  19. Interleukin 4

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

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

  20. Tumor necrosis factor alpha

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

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

  21. Interleukin 6

    measure IL-6 via a bead-based, flow cytometric ELISA (enzyme-linked immunosorbent assay) for the cytokines

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

  22. Interleukin 10

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

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

  23. Albumin

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start16 Apr 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951777
Sponsor's protocol ID
HBTBI02
Status last verified
Jul 2026
First submitted
26 Jun 2023
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous HB-adMSCs and Normal Saline in people with Traumatic Brain Injury, run by Hope Biosciences LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carmen Duron, RN, MHA, BSN (713-500-7395, Maria.Carmen.Duron@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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