Stem Cell Therapy for Traumatic Brain Injury

Recruiting at 2 trial locations

Overseen By Carla Mendoza, BSN, RN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Hope Biosciences

Must not be taking: Antipsychotics, Antidepressants, Immunosuppressants, others

Disqualifiers: Psychiatric conditions, Renal disease, Hepatic disease, Cancer, Immunosuppression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

51 Participants Needed

Trial Summary

What is the purpose of this trial?

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.

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 get a clear answer.

What data supports the effectiveness of the treatment Autologous Adipose Derived Mesenchymal Stem Cells for Traumatic Brain Injury?

Research shows that adipose-derived stem cells (stem cells from fat tissue) can help with recovery in traumatic brain injury by protecting cells and improving function. Additionally, these cells have been used successfully in other conditions, like optic nerve injuries and bone defects, suggesting their potential for healing and regeneration. ^{1 2 3 4 5}

Is stem cell therapy using adipose-derived mesenchymal stem cells safe for humans?

Research indicates that using adipose-derived mesenchymal stem cells (AD-MSCs) in humans is generally safe, as studies have shown no serious adverse events for up to 54 months in patients treated for various conditions. These stem cells have been tested for safety through quality control measures, including checking for contamination and genetic stability, and have shown no harmful effects. ^{2 6 7 8 9}

How is the treatment with Autologous Adipose Derived Mesenchymal Stem Cells different from other treatments for traumatic brain injury?

This treatment uses stem cells taken from a patient's own fat tissue, which can help repair brain damage by reducing inflammation and promoting cell growth, making it unique compared to other treatments that may not use the body's own cells or focus on these mechanisms. ^{1 2 3 10 11}

Research Team

Charles S Cox, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults aged 18-55 with chronic traumatic brain injury, who can consent and communicate in English or Spanish. They should have documented neurological damage unlikely to improve with current treatments and a moderate disability level (GOS-E score >2 and ≤6). Excluded are those with intellectual deficits, psychiatric conditions, other serious health issues, pregnancy, participation in other drug/device trials, inability to undergo PET/DT-MRI tests or follow-up visits, recent infections, HIV+, certain allergies or diseases affecting organs like the liver and kidneys.

Inclusion Criteria

I have lasting brain damage from a head injury that likely won't get better with current treatments.

My condition or injury was diagnosed over 6 months ago.

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

Exclusion Criteria

Chemical or ETOH (Ethanol/Alcohol) dependency that in the opinion of the investigator would preclude participation in the study

I have recently been treated for an infection.

My white blood cell count is below 3,000.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three infusions of autologous HB-adMSCs over a 6-week period with 14-day intervals between infusions

6 weeks

3 visits (in-person), 3 follow-up calls (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 6 months, 12 months, and 2 years post-infusion

2 years

3 visits (in-person), 1 call (telephone)

Treatment Details

Interventions

• Autologous Adipose Derived Mesenchymal Stem Cells

Trial Overview The study is testing the safety and potential benefits of HB-adMSCs (stem cells derived from one's own fat tissue) given through an IV to improve brain structure and function after a traumatic brain injury. It compares this treatment against a saline solution placebo. The focus is on how well patients recover cognitively and structurally from their injuries.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Autologous Adipose Derived Mesenchymal Stem Cells

Group II: Placebo Placebo Group 1 Intervention

Normal Saline

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

Implanting adipose-derived stem cells (ADSCs) in rats with optic nerve injury significantly improved vision function by preventing further degeneration, as measured by the Flash-visual evoked potential (F-VEP) assay.

ADSC therapy reduced inflammation markers associated with optic nerve injury, including proteins from the TLR4 signaling pathway, suggesting that ADSCs may provide a promising treatment for optic nerve injuries in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of adipose-derived stem cells cures the optic nerve injury on rats through inhibiting the expression of inflammation factors in the TLR4 signaling pathway. Wang, LJ., Liu, LP., Gu, XL., et al.[2022]

Adipose-derived stem cell (ASC) treatment significantly reduced cell death and inflammation in an in vitro model of traumatic brain injury (TBI), indicating its potential for cellular protection and recovery.

In an in vivo rat model, ASC treatment led to lower levels of inflammatory markers and neural injury indicators, although it did not result in improved functional recovery compared to TBI alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human adipose-derived stem cell treatment modulates cellular protection in both in vitro and in vivo traumatic brain injury models. Kappy, NS., Chang, S., Harris, WM., et al.[2019]

Intravitreal injection of human adipose stem cell concentrated conditioned media (ASC-CCM) and live adipose stem cells (ASCs) were found to be safe for treating visual deficits caused by mild traumatic brain injury (mTBI), with a safe dose of 1000 ASCs per eye identified.

While both ASC and ASC-CCM improved vision at five months post-injury, ASC-CCM showed better long-term safety and effectiveness, as live ASCs posed a risk of retinal damage and did not persist in the retina, suggesting ASC-CCM may be a superior treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Long-Term Safety and Efficacy Report on Intravitreal Delivery of Adipose Stem Cells and Secretome on Visual Deficits After Traumatic Brain Injury. Rasiah, PK., Jha, KA., Gentry, J., et al.[2022]

Adipose-derived stem cells have shown effectiveness in treating bone defects, particularly in the complex facial and cranial regions, where finding suitable bone transplants can be challenging.

Preclinical experiments indicate that using a patient's own stem cells from adipose tissue for creating personalized bone replacements is safe, and initial experimental therapies in two patients have been successfully conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bone to the chin from adipose-derived stem cells]. Seppänen, R., Miettinen, S.[2015]

Adipose tissue is a promising source for isolating adult stem cells, which have shown potential in tissue engineering and regenerative medicine, supported by extensive preclinical data.

Clinical trials (phases I-III) have demonstrated the safety and efficacy of using autologous adipose-derived cells in various medical fields, including gastroenterology and orthopedics, paving the way for future applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and preclinical translation of cell-based therapies using adipose tissue-derived cells. Gimble, JM., Guilak, F., Bunnell, BA.[2022]

Intra-articular injections of human adipose-derived mesenchymal stem cells (ADSCs) significantly reduced articular cartilage loss in a mouse model of post-traumatic osteoarthritis, indicating their potential as a protective treatment.

The study demonstrated that ADSCs have anti-inflammatory properties, as their conditioned medium suppressed inflammatory gene expression in chondrocytes, suggesting a mechanism for their protective effects against osteoarthritis progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Injections of the Adipose-Derived Mesenchymal Stem Cells Suppress Progression of a Mouse Traumatic Knee Osteoarthritis Model. Wakayama, T., Saita, Y., Nagao, M., et al.[2023]

Adipose-derived stem cells (ADSCs) can be easily harvested from piglets' fat tissue and expanded in culture, maintaining their stem cell characteristics over more than 15 passages.

These ADSCs have the potential to differentiate into neuron-like cells, suggesting that adipose tissue could serve as a viable alternative source for stem cell therapy in treating nervous system injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuron-like differentiation of adipose-derived stem cells from infant piglets in vitro. Huang, T., He, D., Kleiner, G., et al.[2019]

Triple injections of adipose-derived stem cells (ADSCs) significantly improved skin graft survival in a human-to-rat xenograft model by delaying cell-mediated rejection compared to single injections and control groups.

The enhanced survival was linked to increased vascularization and collagen production, along with reduced levels of proinflammatory cytokine IFN-γ and increased immunosuppressive prostaglandin E synthase (PGES) in the grafts, indicating a strong immunomodulatory effect of ADSCs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple Injections of Adipose-Derived Stem Cells Improve Graft Survival in Human-to-Rat Skin Xenotransplantation through Immune Modulation. Jeon, S., Kim, I., Na, YR., et al.[2023]

The study evaluated the safety and efficacy of autologous adipose-derived stem cell (ASC) therapies in 17 patients with severe conditions, finding no serious adverse events over a follow-up period of up to 54 months.

Both ASC-derived products—a scaffold-free osteogenic graft for bone non-union and a biological dressing for chronic wounds—were successfully manufactured and implanted without contamination or genomic issues, demonstrating their feasibility for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. Vériter, S., André, W., Aouassar, N., et al.[2022]

In a study involving rats with traumatic brain injury, administering human adipose-derived mesenchymal stromal cells (MSCs) at both early (3 days) and delayed (14 days) time points led to significant improvements in neurocognitive outcomes and reduced neuroinflammation after one month.

This research highlights the potential of MSCs in regenerative medicine for treating traumatic brain injuries, suggesting that timing of treatment can be crucial for maximizing therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human adipose-derived mesenchymal stem cells for acute and sub-acute TBI. Ruppert, KA., Prabhakara, KS., Toledano-Furman, NE., et al.[2021]

Adipose tissue-derived stromal cells (ASCs) can survive and migrate in the brain after being transplanted into a rat model of traumatic brain injury (TBI), showing potential for therapeutic use.

The transplantation of ASCs not only reduced the lesion area but also stimulated the proliferation of endogenous neural stem cells, suggesting they can positively alter the brain's response to injury and promote regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seven days post-injury fate and effects of genetically labelled adipose-derived mesenchymal cells on a rat traumatic brain injury experimental model. Dori, I., Petrakis, S., Giannakopoulou, A., et al.[2018]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Implantation of adipose-derived stem cells cures the optic nerve injury on rats through inhibiting the expression of inflammation factors in the TLR4 signaling pathway. [2022]

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

Human adipose-derived stem cell treatment modulates cellular protection in both in vitro and in vivo traumatic brain injury models. [2019]

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

A Long-Term Safety and Efficacy Report on Intravitreal Delivery of Adipose Stem Cells and Secretome on Visual Deficits After Traumatic Brain Injury. [2022]

4. Finland pubmed.ncbi.nlm.nih.gov

[Bone to the chin from adipose-derived stem cells]. [2015]

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

Clinical and preclinical translation of cell-based therapies using adipose tissue-derived cells. [2022]

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

Intra-Articular Injections of the Adipose-Derived Mesenchymal Stem Cells Suppress Progression of a Mouse Traumatic Knee Osteoarthritis Model. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Neuron-like differentiation of adipose-derived stem cells from infant piglets in vitro. [2019]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Multiple Injections of Adipose-Derived Stem Cells Improve Graft Survival in Human-to-Rat Skin Xenotransplantation through Immune Modulation. [2023]

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

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. [2022]

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

Human adipose-derived mesenchymal stem cells for acute and sub-acute TBI. [2021]

11. Spain pubmed.ncbi.nlm.nih.gov

Seven days post-injury fate and effects of genetically labelled adipose-derived mesenchymal cells on a rat traumatic brain injury experimental model. [2018]