Stem Cell Therapy for Brain Injury

Overseen By Joiya Arrington, MSN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Hope Biosciences

Must not be taking: Heparin, Lovenox

Disqualifiers: Psychiatric conditions, Renal disease, Cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of a new stem cell treatment, HB-adMSCs, for individuals who have experienced a brain injury. The goal is to determine if the treatment can improve brain function and reduce inflammation after an injury that occurred at least six months prior. Participants will receive three infusions of the treatment over six weeks. Adults with a diagnosed head injury that affects daily life and remains unresponsive to current treatments might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

Is there any evidence suggesting that HB-adMSC infusion is likely to be safe for humans?

Research has shown that HB-adMSCs, a type of stem cell therapy, are under study for their effects on brain injuries. Previous patients experienced improvements in brain function and recovery. Importantly, studies have not reported any major safety concerns so far. The therapy involves infusing stem cells taken from fat tissue, which is generally considered safe in medical settings. While researchers continue to study the treatment, the lack of major side effects in earlier studies suggests it is well-tolerated. Always discuss potential risks with the study team before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HB-adMSCs for brain injury because, unlike traditional treatments like physical therapy and medications that mainly manage symptoms, this therapy uses stem cells to potentially repair and regenerate damaged brain tissue. HB-adMSCs are derived from human adipose (fat) tissue and are infused directly into the body, which may promote healing at the cellular level. This approach offers a novel way to address the root cause of brain injury, aiming to restore function rather than just alleviate symptoms.

What evidence suggests that HB-adMSC infusion might be an effective treatment for brain injury?

Research has shown that HB-adMSCs, a type of stem cell derived from fat tissue, can improve brain function after an injury. In earlier studies, individuals treated with these stem cells demonstrated enhanced thinking and memory. The data also indicate that these stem cells can reduce brain swelling, aiding in healing. Some research suggests that these cells can prevent further damage and enhance overall brain recovery. This trial will evaluate the effectiveness of HB-adMSCs in treating brain injuries, with participants receiving infusions three times over a six-week period. ^{1 6 7 8 9}

Who Is on the Research Team?

Charles S Cox, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your Glasgow Outcome Scale-Extended (GOS-E) score is higher than 2 but not more than 6.

You are able to obtain consent from the subject of your legally authorized representative (LAR) for the purpose of the test.

Ability to obtain consent from the subject or their legally authorized representative (LAR)

Exclusion Criteria

You have HIV.

Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation

I have had spinal surgery, injury, or deformity confirmed by scans or exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

HB-adMSCs will be infused three times over a six week period, spaced 14 days apart

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 6 months and 1 year post-infusion

1 year

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• HB-adMSCs

Trial Overview 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.

How Is the Trial Designed?

Group I: HB-adMSC Experimental Treatment 1 Intervention

HB-adMSCs will be infused three times over a six week period, spaced 14 days apart

Who Is Running the Clinical Trial?

Hope Biosciences

Lead Sponsor

Trials

27

Recruited

470+

Hope Biosciences LLC

Lead Sponsor

Hope Biosciences Research Foundation

Lead Sponsor

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Intranasally delivered bone marrow stromal cells (BMSCs) successfully migrated to spinal cord injuries in rats and contributed to improved hind limb motor function and reduced lesion cavity size over 2 to 4 weeks.

While the intranasal route showed some efficacy, the results were not as pronounced as those achieved with intrathecal BMSC administration, indicating that while intranasal delivery is a viable option, it may be less effective than direct spinal delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal delivery of bone marrow stromal cells to spinal cord lesions. Ninomiya, K., Iwatsuki, K., Ohnishi, Y., et al.[2015]

Transplanting bone marrow stromal cells (BMSCs) embedded in a platelet-rich plasma (PRP) scaffold significantly improves neurological function in rats after intracerebral hemorrhage compared to BMSCs administered in saline.

The use of PRP scaffolds not only enhances the survival of transplanted BMSCs but also promotes endogenous neurogenesis, leading to better integration of the cells and improved recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell therapy with bone marrow stromal cells after intracerebral hemorrhage: impact of platelet-rich plasma scaffolds. Vaquero, J., Otero, L., Bonilla, C., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7250455/

Human adipose-derived mesenchymal stem cells for acute ... Treatment with HB-adMSC at either 3d or 14d after injury resulted in significant improvements in neurocognitive outcome and a change in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05951777

Autologous Adipose-Derived Mesenchymal Stem Cells for ... This study is a prospective, randomized, double-blind, placebo-controlled Phase 2a study of three infusions of autologous HB-adMSCs (Hope Biosciences adipose- ...

3. hope.bio hope.bio/post/department-of-defense-approves-4-9m-for-traumatic-brain-injury-study-using-hope-bio-s-stem-cells

Department of Defense Approves $4.9M for Traumatic ... Department of Defense Approves $4.9M for Traumatic Brain Injury Study Using Hope Bio's Stem Cells ... effectiveness getting cells to ...

4. surgicalneurologyint.com surgicalneurologyint.com/surgicalint-articles/the-preclinical-and-clinical-trials-of-mesenchymal-stem-cells-secretome-in-traumatic-brain-injury-review-of-basic-science/

The preclinical and clinical trials of mesenchymal stem ... This paper offers a concise overview of the use of MSCs and secretomes to prevent secondary brain injury and improve functional outcomes in TBI patients.

5. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-025-06445-y

Mesenchymal stem cell exosomes therapy for the ... Recent studies have demonstrated that MSC-derived exosome injections in traumatic brain injury models effectively mitigate local inflammatory damage and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06163833

Mesenchymal Stromal Cells for Traumatic Brain Injury Preclinical data across a range of different TBI models and injury severities show that human MSCs improve outcome through pleiotropic mechanisms of protection ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024010818

Effects of bone marrow mesenchymal stromal cells-derived ... MSC(M) and MSC(M) derived EVs are promising treatments for TBI in pre-clinical studies, and translation to the clinical domain appears warranted.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10449745/

MesenchymAl stromal cells for Traumatic bRain Injury (MATRIx) Mesenchymal stromal cell (MSC)-based therapy shows promise as MSCs release various soluble factors that can enhance the injury microenvironment.

9. cell.com cell.com/heliyon/fulltext/S2405-8440(24)01081-8

Effects of bone marrow mesenchymal stromal cells-derived ... MSC(M) and MSC(M) derived EVs are promising treatments for TBI in pre-clinical studies, and translation to the clinical domain appears warranted.