CompletedPhase 1/2

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

United States24 participantsStarted 2020-01-01

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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) -

Exclusion criteria

✕. 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),

What they're measuring

Vital Signs (Respiratory Rate)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Temperature)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Systolic Blood Pressure)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Diastolic Blood Pressure)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Pulse Rate)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Oxygen Saturation)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Trial details

NCT IDNCT04063215

SponsorHope Biosciences LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-25

Results submitted2025-10-31

View on ClinicalTrials.gov More Traumatic Brain Injury trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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) -

Exclusion criteria

✕. 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),

What they're measuring

Vital Signs (Respiratory Rate)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Temperature)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Systolic Blood Pressure)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Diastolic Blood Pressure)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Pulse Rate)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Vital Signs (Oxygen Saturation)

Timeframe: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)