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 range

18 Years – 55 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 55 Years

Sex

ALL

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

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)