Stem Cell Therapy for Traumatic Brain Injury

Recruiting at 3 trial locations

Overseen By Carla Mendoza, BSN, RN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Hope Biosciences LLC

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stem cell therapy using Autologous Adipose Derived Mesenchymal Stem Cells to determine if it can improve brain function and reduce inflammation in individuals with traumatic brain injury. The therapy uses cells from the participant's own body to potentially repair damage and enhance cognitive and functional outcomes. Eligible participants must have experienced their brain injury more than six months ago and continue to have symptoms that do not improve with standard treatments. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in brain injury recovery.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that using a person's own fat-derived stem cells, known as ADMSCs, is generally safe. Studies have found that these stem cells are well-tolerated for various health issues. For instance, one study demonstrated that ADMSCs were safe and beneficial for people with spinal cord injuries, improving muscle and bladder function without serious side effects.

In cases of traumatic brain injury, treatments with ADMSCs have proven safe and can enhance brain function. Patients often experience better brain health without major safety concerns. Overall, current research suggests that ADMSCs are safe for humans, although ongoing studies continue to explore their effects and safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Autologous Adipose Derived Mesenchymal Stem Cells for treating traumatic brain injury because these stem cells offer a unique approach by promoting natural healing and tissue regeneration. Unlike standard treatments that might focus on managing symptoms or reducing inflammation, these stem cells can potentially repair damaged brain tissue directly. This regenerative ability comes from the stem cells' capacity to transform into different types of brain cells and support the brain's own repair mechanisms. This innovative method could significantly enhance recovery outcomes compared to current options.

What evidence suggests that this treatment might be an effective treatment for traumatic brain injury?

Research has shown that mesenchymal stem cells (MSCs), which can be taken from fat tissue, may help heal brain damage. In this trial, participants will receive either Autologous Adipose Derived Mesenchymal Stem Cells or a placebo. Studies suggest these cells can reduce swelling and aid recovery in the brain after a traumatic injury. Specifically, MSC infusions have calmed microglia (the brain's immune cells) and improved recovery for people with traumatic brain injury (TBI). Early findings also indicate that exosomes (tiny particles from these stem cells) can help lower the brain's swelling response after injury. These results suggest that MSCs might be beneficial in treating TBI. ^{3 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?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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 LLC

Lead Sponsor

Hope Biosciences Research Foundation

Lead Sponsor

Hope Biosciences

Lead Sponsor

Trials

27

Recruited

470+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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-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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05951777

Autologous Adipose-Derived Mesenchymal Stem Cells for ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11835705/

Mesenchymal stem cells and their extracellular vesicle ... Recently, mesenchymal stem cells (MSCs) have shown promising results in repairing and mitigating brain damage. Studies indicate that MSCs can promote ...

3. 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.

4. childrenslearninginstitute.org childrenslearninginstitute.org/2024/10/16/autologous-adipose-derived-mesenchymal-stromal-cells-for-chronic-traumatic-brain-injury/

Autologous Adipose-Derived Mesenchymal Stromal Cells ... Studies have shown mesenchymal stromal cell (MSC) infusion dampens microglial activation and improves TBI outcomes. This study's objective was ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10399942/

Adipose-derived stem cell exosomes ameliorate traumatic ... In this study, we found that adipose-derived stem cell exosomes (ADSCs-Exo) could reduce the inflammatory response after traumatic brain injury by reducing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05951777

Autologous Adipose-Derived Mesenchymal Stem Cells for ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7084027/

Autologous Transplantation of Adipose-Derived Stem Cells ... Thus, our data suggested that ADSCs transplantation was safe and effective for the treatment of SCI patients. Neurological muscle and neurogenic bladder were ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0233263

Human adipose-derived mesenchymal stem cells for acute ... In this study, human adipose-derived mesenchymal stromal cells (MSCs) were administered at early (3 days) and delayed (14 days) time points after controlled ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846724001069

Traumatic brain injury and stem cell treatments: A review of ... Stem cell therapy is safe and logistically feasible and leads to neurological improvement in patients with traumatic brain injuries.