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Mesenchymal Stem Cell Therapy

Stem Cell Therapy for Brain Injury

Phase 1 & 2
Waitlist Available
Led By Charles S Cox, MD
Research Sponsored by Hope Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Onset or diagnosis of the injury or disease process greater than 6 months
Ability to speak English or Spanish (required for validated neurocognitive outcome testing)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6), change from screening at 1 year post-infusion (visit 7)
Awards & highlights

Study Summary

This trial will test whether it is safe to give patients brain injury an infusion of HB-adMSC cells, and whether these cells improve brain function.

Who is the study for?
Adults aged 18-55 with traumatic brain injury or hypoxic-ischemic encephalopathy for over 6 months, who have a moderate to severe disability (GOS-E score >2 and ≤6), can consent, and speak English/Spanish. Excludes those with cancer, immune or bleeding disorders, severe lung disease, normal brain scans, certain heart valves/prosthetic issues, kidney/liver disease, HIV+, substance dependency or other conditions that may increase risk.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of HB-adMSCs infusion therapy on adults with chronic neurological injuries. It evaluates how this treatment affects brain structure and function as well as inflammation in the nervous system.See study design
What are the potential side effects?
While specific side effects are not listed here for HB-adMSCs infusion therapy in treating neurological injuries; generally stem cell therapies might cause reactions at the injection site, infection risks due to immunosuppression potential or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition or injury was diagnosed over 6 months ago.
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I can speak English or Spanish.
Select...
I am between 18 and 55 years old.
Select...
I have a head injury with lasting brain damage that current treatments can't fix.
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I am between 18 and 55 years old.
Select...
I have a head injury with lasting brain damage that won't get better with current treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, change from baseline at imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, change from baseline at imaging visit #2, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Basos
Absolute Eos
Absolute Immature Granulocytes
+34 more
Secondary outcome measures
Albumin
Automated Neuropsychological Assessment Metrics
Galveston Orientation and Amnesia Test
+12 more

Side effects data

From 2021 Phase 2 trial • 53 Patients • NCT04348435
47%
Influenza like illness
42%
Headache
16%
Myalgia
11%
Visual impairment
11%
Nausea
11%
Muscle fatigue
5%
Back injury
5%
Ageusia
5%
Joint swelling
5%
Vertigo
5%
Leukocytosis
5%
Atrial fibrillation
5%
Corona virus Infection
5%
Back pain
5%
Dizziness
5%
Paresthesia
5%
Muscle rigidity
5%
Anosmia
5%
Fatigue
5%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allogeneic HB-adMSCs 200MM
Allogeneic HB-adMSCs 100MM
Allogeneic HB-adMSCs 50MM
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: HB-adMSCExperimental Treatment1 Intervention
HB-adMSCs will be infused three times over a six week period, spaced 14 days apart
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HB-adMSCs
2020
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Hope BiosciencesLead Sponsor
23 Previous Clinical Trials
302 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
902 Previous Clinical Trials
320,880 Total Patients Enrolled
Charles S Cox, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
4 Previous Clinical Trials
108 Total Patients Enrolled

Media Library

Traumatic Brain Injury Clinical Trial 2023: HB-adMSCs Highlights & Side Effects. Trial Name: NCT04063215 — Phase 1 & 2
Traumatic Brain Injury Patient Testimony for trial: Trial Name: NCT04063215 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently partaking in this clinical experiment?

"This clinical trial is no longer accepting applicants. The study was first published on January 1, 2020 and its details were last updated on May 27, 2022. If you're still searching for studies to participate in, there are 1047 trials recruiting patients with brain diseases and 6 additional ones seeking participants diagnosed with HB-adMSCs."

Answered by AI

Are there any contemporaneous research projects involving HB-adMSCs?

"Presently, there are 6 medical trials involving HB-adMSCs. None of these experiments have reached the third phase yet. While most research is being conducted in Sugar Land, Texas, there are also 7 other clinical sites running studies on this treatment option."

Answered by AI

Does this research study allow individuals over 35 years of age to participate?

"This trial is open to those aged 18-55, while there are other trials available for both younger and older patients. Specifically, 216 studies cater to minors and 802 focus on geriatric demographics."

Answered by AI

For whom would this clinical trial be a suitable option?

"This clinical trial is taking applications from 18-55 year olds who are suffering from a neurological condition that has been present for over 6 months. Furthermore, applicants must have a Glasgow Outcome Scale score between 2 and 6 inclusive, the ability to obtain consent or be represented by an LAR, and fluency in either English or Spanish (for validated neurocognitive testing). A total of 24 participants will receive treatment."

Answered by AI

Is the recruitment for this clinical trial still ongoing?

"At this time, no new participants are being welcomed into this research. The trial was first posted in January 2020 and the latest update on it occurred May 27th 2022. However, if you're looking for other trials to join, there are 1047 studies actively seeking volunteers with brain diseases and 6 studies that involve HB-adMSCs accepting applicants."

Answered by AI

What is the ultimate goal of this clinical investigation?

"The main metric being measured in this trial is Absolute Lymphs, which will be recorded at Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6) and lastly Change from Screening at one year post-infusion (Visit 7). Secondary outcomes include Whole brain MRI using DTI to evaluate both macro and microstructural features; Verbal Fluency Test for vocabulary size assessment as well as rapidity of lexical access, updating prowess and inhibition quality; Glasgow Outcome Score"

Answered by AI

Does this trial represent a pioneering approach in its field?

"Currently, 6 clinical trials utilising HB-adMSCs are active over 4 cities and 1 nation. Initially conducted in 2020 by Hope Biosciences with 24 participants, Phase 1 & 2 drug approval stage was successfully reached. Since its inception 5 years ago, the study has seen a total of five completed trials."

Answered by AI

Who else is applying?

What state do they live in?
Texas
North Carolina
What site did they apply to?
Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

What questions have other patients asked about this trial?

Would I be compensated for travel?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I’ve had issues with my TBI for years and haven’t found much needed relief.
PatientReceived 1 prior treatment
I am interested in research and finding opportunities to help improve my health.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU): < 24 hours
Average response time
  • < 1 Day
~3 spots leftby Dec 2024