Stem Cell Therapy for Chronic and Acute Conditions

Overseen By Karen Mulholland Angelus

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Thomas Advanced Medical LLC

Disqualifiers: Malignancy, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of stem cell therapy for various conditions, from chronic issues like autoimmune diseases to acute problems like viral illnesses. The focus is on a special tissue substance rich in stem cells, known as PrimePro™ or PrimeMSK™, to determine its potential in improving these health conditions. Individuals with frequent asthma attacks, diabetes complications, or musculoskeletal disorders might be suitable candidates. As a Phase 1 and Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking medical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that mesenchymal stem cells (MSCs), used in treatments like PrimePro™ and PrimeMSK™, are generally safe for various conditions. Research on bone and skin disorders indicates that MSCs usually cause only mild side effects, such as a temporary fever, meaning people typically handle the treatment well.

For autoimmune diseases, studies show that MSC infusions are safe, with few negative effects. In lung conditions, MSCs have been found to be safe and may help reduce inflammation.

Research on sexual dysfunction suggests MSC therapy is safe and may offer benefits. In urologic disorders, early findings also support the safety of these treatments.

For viral illnesses, while MSCs are generally considered safe, researchers advise caution as the treatment remains under study for these conditions.

In heart diseases, studies report that MSCs are safe and may aid treatment. In diabetes complications, some trials mention potential risks like blood clots and tissue thickening, though these are uncommon.

Lastly, in brain disorders, MSCs are considered safe, with ongoing research to explore their full potential.

Overall, MSCs in these treatments have a strong safety record, but like any medical treatment, monitoring for side effects is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PrimePro™ and PrimeMSK™ because they use a cutting-edge approach involving stem cells derived from amniotic and umbilical cord tissues. Unlike traditional treatments that may focus on symptom management or inflammation reduction, these therapies aim to promote healing and tissue regeneration at the cellular level. This innovative mechanism could potentially offer more comprehensive and long-lasting benefits for a variety of conditions, from musculoskeletal disorders to autoimmune diseases. Moreover, the potential for these treatments to address multiple conditions with a single therapeutic approach is a significant advancement over current specialized treatments.

What evidence suggests that this trial's treatments could be effective?

This trial will evaluate the effectiveness of an amniotic and umbilical cord stem cell-rich tissue substance, PrimePro™/PrimeMSK™, across various treatment arms. Research has shown that mesenchymal stem cells (MSCs), the main component of PrimePro™/PrimeMSK™, hold promise for treating various conditions.

In the integumentary disease arm, MSCs have demonstrated healing and regenerative abilities for skin diseases. The musculoskeletal disorders arm will explore how MSCs can help repair joint and bone injuries, reducing pain and improving movement. For the pulmonary disorders arm, MSCs have been effective in reducing inflammation and aiding recovery in lung issues.

In the sexual dysfunction arm, MSCs have shown potential in improving erectile function by repairing tissues. The urologic disorders arm will investigate MSCs' promise in regenerating damaged tissues for urinary problems. In the autoimmune diseases arm, MSCs can reduce inflammation and calm the immune system's harmful activity.

For the cardiovascular disorders arm, MSCs have been noted to improve heart function and recovery after injury. The diabetes complications arm will assess how MSCs can help control blood sugar levels and reduce the need for insulin. In the neurodegenerative disorders arm, MSCs may protect nerves and aid in brain repair. Lastly, the viral illnesses arm will evaluate MSCs' potential in reducing inflammation and supporting the immune system. ^{1 2 3 4 6}

Who Is on the Research Team?

Ernst R Von Schwarz, MD, PhD

Principal Investigator

HeartStem Institute, Southern California Hospital at Culver City

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can attend follow-up visits and give informed consent. It's not suitable for those with recent cancer history (within the last 2 years), pregnant or breastfeeding individuals, or anyone unable to consent.

Inclusion Criteria

Ability to provide informed consent

I can attend all required follow-up visits.

Exclusion Criteria

I have had cancer in the last 2 years.

Pregnancy or breast-feeding

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stem cell therapy for various acute and chronic conditions

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PrimePro™/ PrimeMSK™

Trial Overview The study tests stem cell therapies called PrimePro™/PrimeMSK™ on a range of conditions including musculoskeletal, neurological, skin diseases, cardiovascular issues, diabetes, neurodegenerative and lung diseases, autoimmune disorders, sexual dysfunction and viral infections.

How Is the Trial Designed?

Group I: Arm 9: Urologic Disorders Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for urologic conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group II: Arm 8: Sexual Dysfunction Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for sexual dysfunction conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group III: Arm 7: Pulmonary Disorders Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for pulmonary disorders. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group IV: Arm 6: Neurodegenerative Disorders Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for neurologic and neurodegenerative disorders. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group V: Arm 5: Musculoskeletal Disorders Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for orthopedic and musculoskeletal conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group VI: Arm 4: Integumentary Disease Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for integumentary diseases and conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group VII: Arm 3: Diabetes Complications Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for diabetes complications. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group VIII: Arm 2: Cardiovascular Disorders Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for cardiovascular disorders and conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group IX: Arm 1: Autoimmune Diseases Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for autoimmune conditions. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Group X: Arm 10: Viral Illnesses Experimental Treatment 1 Intervention

Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for viral illnesses. Outcomes will be compared to results in peer-reviewed literature for several conditions.

Who Is Running the Clinical Trial?

Thomas Advanced Medical LLC

Lead Sponsor

Trials

2

Recruited

5,000+

HeartStem Institute

Collaborator

Trials

2

Recruited

5,000+

NuStem

Collaborator

Trials

1

Recruited

5,000+

Published Research Related to This Trial

Mesenchymal stromal cells (MSC) have shown potential in tissue repair and regeneration across various organ systems, including cardiovascular and neurological applications, based on both preclinical and clinical studies.

MSC possess strong immunosuppressive properties and can be manufactured for clinical use without the need for tissue matching between donor and recipient, making them a promising 'off-the-shelf' therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic applications of mesenchymal stromal cells. Brooke, G., Cook, M., Blair, C., et al.[2018]

The study found that adding peripheral blood mononuclear cells (PBMC) to autologous plasma clots significantly enhances the osteogenic differentiation of mesenchymal stem cells (MSC), suggesting a promising method for bone regeneration.

Using this approach, the presence of PBMC in plasma clots led to increased expression of osteocalcin and promoted bone nodule formation, indicating that this method could be an effective strategy for treating bone fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteogenic differentiation of human mesenchymal stromal cells is promoted by a leukocytes containing fibrin matrix. Seybold, D., Schildhauer, TA., Gessmann, J., et al.[2021]

Multipotent mesenchymal stromal cells (MMSCs) show potential as a treatment for sepsis and septic shock, based on experimental data from cell cultures and various animal models.

The article reviews the mechanisms and effects of MMSCs, highlighting their therapeutic applications in managing severe infections and inflammatory responses associated with sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

USE OF MESENCHYMAL STROMAL STEM CELLS FOR THE TREATMENT OF SEPSIS. Galstyan, GM., Makarova, PM., Parovichnikova, EN.[2018]

Mesenchymal stromal cells (MSCs) have shown therapeutic effects in various animal models of tissue injury, likely due to their ability to produce beneficial factors and migrate to injured tissues, although the exact mechanisms are not fully understood.

MSCs possess immunosuppressive properties, making them a promising candidate for treating conditions like acute myocardial infarction and autoimmune diseases, but challenges such as standardization and long-term safety need to be addressed before widespread clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mesenchymal stromal cells: Biological properties and clinical prospects]. Roux, S., Leotot, J., Chevallier, N., et al.[2021]

The study outlines effective procedures for isolating and expanding bone marrow stromal cells (BMSCs) under good manufacturing practices (GMP), ensuring a sufficient quantity for therapeutic use.

These methods successfully maintain the biological potency of BMSCs, which is crucial for their application in regenerative medicine and skeletal repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Isolation and Manufacture of GMP-Grade Bone Marrow Stromal Cells from Bone Specimens. Dias, RB., Bonfim, DC.[2021]

Multipotent mesenchymal stem cells (MSCs) have the ability to differentiate into various cell types, making them a promising tool for regenerative medicine.

Originally discovered in the bone marrow, MSCs have been studied for their potential in treating a variety of conditions due to their unique properties and mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances in Translational Adipose-Derived Stem Cell Biology. Widera, D.[2021]

A meta-analysis of 152 randomized clinical trials involving 9228 individuals treated with mesenchymal stromal cells (MSCs) found that fever is the only adverse event closely associated with MSC therapy, with a significant odds ratio of 1.61.

The analysis also indicated that MSC therapy may lower the incidence of tachycardia and fatigue, although these findings were not statistically significant, suggesting a generally favorable safety profile for MSC treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient Fever: the Sole Treatment-Related Adverse Event associated with Mesenchymal Stromal Cells and Solid Clues from the Real World. Wang, Y., Mou, Q., Yi, H., et al.[2023]

Mesenchymal stromal cells (MSCs) are promising for treating various diseases due to their immune-suppressive properties and regenerative capabilities, with unmodified MSCs showing good safety profiles in clinical settings.

Genetically engineered MSCs, while offering enhanced therapeutic potential, require thorough non-clinical safety assessments to evaluate risks associated with introducing new genes, especially when using non-viral modification methods to minimize risks of cell transformation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations in the Design of Non-Clinical Development Programmes to Support Non-Viral Genetically Modified Mesenchymal Stromal Cell Therapies. Iansante, V., Brooks, A., Coney, L.[2021]

A comprehensive safety evaluation system for human umbilical cord mesenchymal stromal cells (HUCMSCs) was developed, ensuring quality control and compliance with existing regulations for cell-based therapies.

In a clinical study involving 225 patients over one year, no severe adverse reactions were reported, indicating that HUCMSC therapy is safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products. Xie, Y., Liu, W., Liu, S., et al.[2021]

Mesenchymal stromal cells (mSCs) are being researched for their potential to treat various diseases, including acute graft-versus-host disease and cardiac issues, by utilizing their ability to release factors that help reduce inflammation and promote healing.

mSCs grown in platelet lysate show faster growth and stronger immunosuppressive effects compared to those grown in fetal calf serum, suggesting that the growth medium can significantly influence their therapeutic properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesenchymal stromal cells: main factor or helper in regenerative medicine? Zander, AR., Lange, C., Westenfelder, C.[2021]

Mesenchymal stem cells (MSCs) are safe for clinical use and have shown promising results in suppressing graft versus host disease and supporting the engraftment of transplanted stem cells, based on various clinical studies.

Despite not fully understanding how MSCs work, their immunomodulatory properties and potential benefits justify their use in treating a wide range of disorders, highlighting the need for further research into their mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mesenchymal stem cells: immunomodulatory properties and clinical application]. Golemović, M., Skifić, M., Cepulić, BG.[2018]

Mesenchymal stromal cell (MSC) therapy has shown great clinical potential, but there are significant risks and adverse events associated with its use, including thromboembolism and fibrosis, as reported in clinical trials.

The methods of processing MSCs, such as isolation and culturing, can lead to complications like chromosomal abnormalities and contamination, highlighting the need for improved safety protocols and a checklist for clinicians before administering MSC therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events, side effects and complications in mesenchymal stromal cell-based therapies. Baranovskii, DS., Klabukov, ID., Arguchinskaya, NV., et al.[2022]

Mesenchymal stem cells (MSCs) have shown promise as a new treatment option for various diseases due to their unique properties, including the ability to differentiate into different cell types and modulate immune responses.

A total of 425 MSC-based clinical trials have been conducted, with many demonstrating both safety and efficacy, particularly in treating bone defects and injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cells and Cell Therapy for Bone Repair. Wang, S., Xu, P., Li, X., et al.[2019]

Mesenchymal stem cells (MSCs) have the unique ability to differentiate into various cell types and can migrate to inflammation sites, providing immunosuppressive and anti-inflammatory effects, making them promising for treating a range of disorders.

Currently, MSCs are being tested in clinical trials for conditions like orthopedic injuries, autoimmune diseases, and even cancer therapy, showcasing their potential therapeutic applications despite some limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of mesenchymal stem cells. Kim, N., Cho, SG.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39934871/

Efficacy and safety of mesenchymal stromal cell ... This study aims to assess the effectiveness and safety of mesenchymal stem cell (MSC) transplantation in the treatment of autoimmune and rheumatic immune ...

2. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04184-x

Efficacy and safety of mesenchymal stromal cell ... This study aims to assess the effectiveness and safety of mesenchymal stem cell (MSC) transplantation in the treatment of autoimmune and rheumatic immune ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0300908424000841

Mesenchymal stem cells in autoimmune disease MSCs have been shown to improve preclinical outcomes of murine models of MS with reduced inflammatory cell infiltration and reduced demyelination in the spinal ...

4. nature.com nature.com/articles/s41392-025-02313-9

Mesenchymal stem cells in treating human diseases AD-MSCs have also been demonstrated to have immunosuppressive effects, inhibiting the proliferation of peripheral blood mononuclear cells (PBMCs) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06888973

Study Details | NCT06888973 | Mesenchymal Stem Cells ... The goal of this study is to learn if mesenchymal stem cell therapy (treatment group) can effectively treat autoimmune diseases, when compared to normal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6236873/

Safety analysis in patients with autoimmune disease ... Our data shows that mesenchymal stem cell infusion is a safe therapy for patients with autoimmune diseases. The incidences of adverse events, ...