What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) that focus on regeneration and anti-inflammation, such as HB-adMSC infusion, may have side effects including immune reactions, infection at the injection site, and potential tumor formation. Anti-inflammatory treatments like glucocorticoids can cause elevated blood sugar, gastrointestinal issues, and increased infection risk. Monitoring for both known and unforeseen adverse effects is essential in these therapies.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for Traumatic Brain Injury (TBI) that focus on regeneration and anti-inflammation similar to the HB-adMSC infusion being studied. Most treatments for TBI are supportive and symptomatic, addressing issues such as reducing intracranial pressure and managing symptoms. Research is ongoing in the field of regenerative medicine, including the use of mesenchymal stem cells, but these therapies are still largely in the experimental stages and have not yet received FDA approval for TBI.

What other types of research exist?

Promising novel alternatives to HB-adMSC infusion for TBI patients include: 1) Human adipose-derived stem cells (ASCs), which have shown potential in modulating cellular protection and improving functional recovery in TBI models. 2) Bone marrow-derived mononuclear cells (BMCs), which have been tested for their regenerative capabilities in neurological injuries. 3) Anti-myelin-associated glycoprotein antibody (anti-MAG mAb) treatment, which has demonstrated tissue sparing and functional recovery benefits in experimental TBI models. These alternatives focus on both regeneration and anti-inflammation, making them viable options for consideration in 2024.

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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

No Placebo-Only Group

Summary

This trial is testing the safety and effects of infusing special stem cells (HB-adMSC) into adults with brain injuries. The goal is to see if these stem cells can help repair brain damage and reduce inflammation, potentially improving thinking and movement abilities. Researchers will look at changes in brain structure and function to determine the treatment's effectiveness.

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.

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.

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 weeks3 visits

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)

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute Basos

Absolute Eos

Absolute Immature Granulocytes

+34 more

Secondary study objectives

Albumin

Automated Neuropsychological Assessment Metrics

Galveston Orientation and Amnesia Test

+12 more

Side effects data

From 2021 Phase 2 trial • 53 Patients • NCT04348435

25%

Headache

17%

Muscle fatigue

Urinary tract infection

Fracture

Appendicectomy

Rotator cuff repair

Myalgia

Hypoaesthesia

Pain

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Allogeneic HB-adMSCs 50MM

Allogeneic HB-adMSCs 200MM

Allogeneic HB-adMSCs 100MM

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 14Eligibility criteria met

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.