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

This study is testing a treatment called Autologous HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) for chronic traumatic brain injury. Researchers want to see if these cells, given as an intravenous infusion (into a vein), are safe and can help improve brain structure, thinking abilities, and reduce inflammation after a brain injury. You might be able to join if you are between 18 and 55 years old, have documented brain damage from a head injury that happened more than 6 months and up to 20 years ago, and your injury is not expected to get better with current treatments. The study will measure changes in blood markers like glucose, calcium, and albumin over time to see if the treatment has an effect. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled Phase 2a study. It plans to enroll 51 participants.
What's involved
Participants will receive three infusions over a 6-week period, with 14 days between each infusion. You will be monitored for at least 1 hour after each infusion and by phone 24 hours later.
Compensation
Not stated in the trial record.
Follow-up
Participants will have safety assessments at clinic visits 6 and 12 months after the last infusion, and a telephone call at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05951777

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

Recruiting
PHASE2Ages 18–55InterventionalTreatment
Hope Biosciences LLC
~51 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Autologous HB-adMSCsNormal Saline

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glucose
Measured over 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 more outcomes measured

Conditions

Traumatic Brain Injury

Explore related trials

Traumatic Encephalopathy

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Charles S Cox, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Carmen Duron, RN, MHA, BSN
[email protected]
713-500-7395
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • GlucoseWeek 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)

  • CalciumWeek 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)

  • AlbuminWeek 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)

  • Total ProteinWeek 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)

  • SodiumWeek 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)

  • Total carbon dioxideWeek 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)

  • PotassiumWeek 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)

  • ChlorideWeek 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)

  • BUN (blood urea nitrogen)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)

  • CreatinineWeek 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

  • Alkaline phosphataseWeek 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)

  • Alanine aminotransferaseWeek 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)

  • Aspartate aminotransferaseWeek 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)

  • Total BilirubinWeek 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)

  • White blood cellWeek 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)

  • Red blood cellWeek 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)

  • HemoglobinWeek 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)

  • HematocritWeek 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 (%)

  • Mean corpuscular volumeWeek 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)

  • Mean corpuscular hemoglobinWeek 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)

  • Mean corpuscular hemoglobin concentrationWeek 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)

  • Red cell distribution widthWeek 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 (%)

  • NeutrophilsWeek 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 (%)

  • LymphocytesWeek 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 (%)

  • MonocytesWeek 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 (%)

  • EosinophilsWeek 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 (%)

  • BasophilsWeek 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 (%)

  • Absolute NeutrophilsWeek 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)

  • Absolute lymphocytesWeek 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)

  • Absolute monocytesWeek 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)

  • Absolute eosinophilsWeek 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)

  • Absolute basophilsWeek 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)

  • Immature GranulocytesWeek 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 (%)

  • Absolute Immature GranulocytesWeek 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)

  • PlateletsWeek 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)

  • Prothrombin TimeWeek 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)

  • INR (international normalized ratio)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)

  • Urine Pregnancy (if applicable)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)