Stem Cell Therapy for Chronic and Acute Conditions

Overseen By Karen Mulholland Angelus

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Thomas Advanced Medical LLC

Disqualifiers: Malignancy, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing stem cell therapy, which uses special cells to repair or replace damaged tissues. It targets patients with a range of acute and chronic conditions that may not respond well to traditional treatments. The therapy works by transforming stem cells into the needed cell types to improve organ and tissue function.

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.

What data supports the effectiveness of the treatment PrimePro™/ PrimeMSK™ for chronic and acute conditions?

Research shows that mesenchymal stem cells (MSCs), a key component of PrimePro™/ PrimeMSK™, have been effective in treating various conditions due to their ability to reduce inflammation and support tissue repair. Clinical trials have demonstrated the safety and efficacy of MSCs in treating bone defects, autoimmune diseases, and other disorders, suggesting potential benefits for chronic and acute conditions. ^{1 2 3 4 5}

Is stem cell therapy generally safe for humans?

Clinical studies have shown that mesenchymal stem cells (MSCs) are generally safe, with transient fever being a common mild side effect. However, some trials have reported more serious issues like thromboembolism (blood clots) and fibrosis (thickening of tissue), which depend on individual patient factors. ^{5 6 7 8 9}

How is the treatment PrimePro™/ PrimeMSK™ different from other treatments for chronic and acute conditions?

PrimePro™/ PrimeMSK™ uses mesenchymal stem cells (MSCs), which are unique because they can migrate to injured tissues and help repair them by producing anti-inflammatory and anti-apoptotic factors. This treatment is different from others because it leverages the natural ability of MSCs to modulate the immune system and promote tissue regeneration, offering a novel approach to treating various conditions. ^{10 11 12 13 14}

Research Team

Ernst R Von Schwarz, MD, PhD

Principal Investigator

HeartStem Institute, Southern California Hospital at Culver City

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

I have had cancer in the last 2 years.

Pregnancy or breast-feeding

Inability to provide informed consent

Trial Timeline

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

Treatment Details

Interventions

• PrimePro™/ PrimeMSK™ (Stem Cell Therapy)

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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 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]

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 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 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]

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]

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]

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]

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]

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]

References

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

Mesenchymal stromal cells: main factor or helper in regenerative medicine? [2021]

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

Clinical applications of mesenchymal stem cells. [2022]

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

Therapeutic applications of mesenchymal stromal cells. [2018]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

USE OF MESENCHYMAL STROMAL STEM CELLS FOR THE TREATMENT OF SEPSIS. [2018]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cells and Cell Therapy for Bone Repair. [2019]

6. United Arab Emirates 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. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Adverse events, side effects and complications in mesenchymal stromal cell-based therapies. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Considerations in the Design of Non-Clinical Development Programmes to Support Non-Viral Genetically Modified Mesenchymal Stromal Cell Therapies. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Osteogenic differentiation of human mesenchymal stromal cells is promoted by a leukocytes containing fibrin matrix. [2021]

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

The Isolation and Manufacture of GMP-Grade Bone Marrow Stromal Cells from Bone Specimens. [2021]

12. France pubmed.ncbi.nlm.nih.gov

[Mesenchymal stromal cells: Biological properties and clinical prospects]. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

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

14. Croatia pubmed.ncbi.nlm.nih.gov

[Mesenchymal stem cells: immunomodulatory properties and clinical application]. [2018]