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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
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
Must not have
Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam
Unwilling or unable to return for follow-up study visits
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

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
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I am between 18 and 55 years old.
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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.
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I have a head injury with lasting brain damage that won't get better with current treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had spinal surgery, injury, or deformity confirmed by scans or exams.
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I cannot commit to returning for follow-up visits.
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I cannot or do not want to undergo certain cancer imaging tests.
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My white blood cell count is below 3,000.
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I have a bleeding disorder, such as heparin-induced thrombocytopenia.
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I do not have a mental health condition that affects my thinking or behavior.
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I need medication, oxygen, or a ventilator for my lung condition.
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My kidney function is impaired (creatinine > 1.5 mg/dL).
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My liver is not functioning properly.
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I have a genetic or metabolic disorder linked to my neurological condition.

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 pain
5%
Leukocytosis
5%
Dizziness
5%
Vertigo
5%
Corona virus Infection
5%
Back injury
5%
Ageusia
5%
Joint swelling
5%
Atrial fibrillation
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
~170

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Traumatic Brain Injury (TBI) often focus on reducing inflammation and promoting tissue regeneration. Mesenchymal stem cell (MSC) therapy, such as HB-adMSC infusion, aims to modulate immune responses and enhance repair mechanisms. MSCs can secrete anti-inflammatory cytokines and growth factors that help reduce neuroinflammation and support the regeneration of damaged brain tissue. This is crucial for TBI patients as it can potentially improve neurocognitive and functional outcomes, reduce long-term disability, and enhance overall recovery by addressing both the inflammatory and degenerative aspects of brain injury.
Why Does Brain Trauma Research Fail?Membrane transporters in traumatic brain injury: Pathological, pharmacotherapeutic, and developmental implications.Guidelines for head injury: their use and limitations.

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
919 Previous Clinical Trials
325,017 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
~2 spots leftby Dec 2024
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