Stem Cell Therapy for Brain Injury

Overseen By Joiya Arrington, MSN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Hope Biosciences

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment HB-adMSCs for brain injury?

Research shows that bone marrow stromal cells (BMSCs), similar to HB-adMSCs, can help improve brain function after injuries like traumatic brain injury and intracerebral hemorrhage by promoting brain cell growth and recovery. ^{1 2 3 4 5}

Is stem cell therapy safe for brain injury treatment?

Research on fetal human neural stem cells (hNSCs) in rats with brain injuries showed no evidence of tumor formation, suggesting they are safe for transplantation. Additionally, human amniotic mesenchymal stem cells (hAMSCs) have been studied in rats and showed positive effects without safety concerns, indicating potential safety in humans. ^{1 6 7 8 9}

How is the treatment HB-adMSCs for brain injury different from other treatments?

The treatment HB-adMSCs (human bone marrow-derived stem cells) is unique because it involves using stem cells to potentially repair brain damage by promoting the growth of new neurons (nerve cells) and supporting brain recovery, which is different from traditional treatments that may not directly target brain repair. ^{1 4 10 11 12}

Research Team

Charles S Cox, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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 speak English or Spanish *required for validated neurocognitive outcome testing) -

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

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)

Treatment Details

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.

Participant Groups

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+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Bone Marrow Stromal Cells Promote Neuronal Restoration in Rats with Traumatic Brain Injury: Involvement of GDNF Regulating BAD and BAX Signaling. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of traumatic brain injury in adult rats with intravenous administration of human bone marrow stromal cells. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Delayed intralesional transplantation of bone marrow stromal cells increases endogenous neurogenesis and promotes functional recovery after severe traumatic brain injury. [2014]

4. China pubmed.ncbi.nlm.nih.gov

[Differentiation of bone marrow-derived stem cells in injured rat brain tissue]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Late transplantation of allogeneic bone marrow stromal cells improves neurologic deficits subsequent to intracerebral hemorrhage. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing fetal human neural stem cells tumorigenicity potential in athymic rats with penetrating traumatic brain injury (pTBI). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Transplantation of human amniotic mesenchymal stem cells promotes neurological recovery in an intracerebral hemorrhage rat model. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Intranasal delivery of bone marrow stromal cells to spinal cord lesions. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Neurotherapeutic effect of cord blood derived CD45+ hematopoietic cells in mice after traumatic brain injury. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

Intralesional administration of allogeneic bone marrow stromal cells reduces functional deficits after intracerebral hemorrhage. [2017]

11. Iran pubmed.ncbi.nlm.nih.gov

Therapeutic benefit of intravenous administration of human umbilical cord blood- mononuclear cells following intracerebral hemorrhage in rat. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Cell therapy with bone marrow stromal cells after intracerebral hemorrhage: impact of platelet-rich plasma scaffolds. [2018]