Stem Cell Therapy for Lung Disease

(ADcSVF-COPD Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Healeon Medical Inc

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Pregnancy, Alcohol dependence, Hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for COPD that involves injecting special cells from fat tissue into the bloodstream. It aims to help patients who do not get better with usual treatments by reducing lung inflammation and improving breathing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on chronic immunosuppressive or chemotherapeutic medications. It's best to discuss your specific medications with the trial team.

What evidence supports the effectiveness of the treatment AD-cSVF for lung disease?

Research indicates that stem cell-based treatments, including those using mesenchymal stem cells (MSCs), show promise in treating lung diseases like pulmonary fibrosis and chronic obstructive pulmonary disease (COPD) by reducing inflammation and promoting tissue repair. ^{1 2 3 4 5}

Is stem cell therapy, including AD-cSVF, generally safe for humans?

Stem cell therapies, including those using adipose-derived stromal/stem cells (AD-cSVF), have been studied in various conditions and generally show a good safety profile in humans. Most studies report few serious side effects, with the main issues being post-procedure pain and, in some cases, transient fever. However, there are reports of potential risks like thromboembolism (blood clots) and fibrosis (thickening of tissue), which should be considered. ^{6 7 8 9 10}

How does the treatment AD-cSVF differ from other treatments for lung disease?

AD-cSVF is a stem cell therapy that uses adipose-derived cells, which are believed to help repair lung tissue by reducing inflammation and promoting healing, unlike traditional treatments that may not target the underlying tissue damage directly. ^{1 2 3 5 11}

Research Team

Robert W Alexander, MD

Principal Investigator

Healeon Medical Inc

Glenn C. Terry, MD

Principal Investigator

Global Alliance for Regenerative Medicine (GARM)

Eligibility Criteria

This trial is for adults with moderate to severe COPD, a lung condition causing poor airflow and difficulty breathing. Candidates must not have hepatitis (except past Hepatitis A), drug/alcohol dependence, life expectancy under 3 months due to other illnesses, inherited Alpha-1 Antitrypsin Deficiency, or be pregnant/lactating. They shouldn't have used investigational drugs within the last month or be on chronic immunosuppressive/chemotherapy treatments.

Inclusion Criteria

I have been diagnosed with moderate to severe COPD.

My COPD is moderate to very severe.

Exclusion Criteria

I have Alpha-1 Antitrypsin Deficiency.

I am unable or unwilling to understand or sign a consent form.

I am on long-term medication to suppress my immune system or for chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo microcannula harvesting of subdermal adipose tissues, followed by incubation, digestion, and isolation of AD-cSVF, which is then suspended in sterile Normal Saline and deployed via peripheral intravenous route.

12 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pulmonary function tests and other evaluations.

12 months

Periodic visits for follow-up assessments

Treatment Details

Interventions

• AD-cSVF

Trial Overview The study tests the safety and effectiveness of using one's own adipose-derived stem/stromal cells (ADcSVF) obtained via lipoaspiration in treating COPD symptoms. It involves comparing results from this new intervention against normal saline IV treatment as a control.

Participant Groups

Group I: Normal Saline IV Arm 3 Experimental Treatment 1 Intervention

Normal Saline IV with AD-cSVF cells

Group II: Lipoaspiration Arm 1 Experimental Treatment 1 Intervention

Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat

Group III: AD-cSVF Arm 2 Experimental Treatment 1 Intervention

Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)

Who Is Running the Clinical Trial?

Healeon Medical Inc

Lead Sponsor

Trials

9

Recruited

710+

Terry, Glenn C., M.D.

Collaborator

Trials

5

Recruited

460+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Paracrine effects and heterogeneity of marrow-derived stem/progenitor cells: relevance for the treatment of respiratory diseases. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Stem cells and cystic fibrosis. [2012]

3. China pubmed.ncbi.nlm.nih.gov

Cell-based therapy for idiopathic pulmonary fibrosis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Clinical applications of mesenchymal stem cells in chronic lung diseases. [2020]

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

Therapeutic potential of stem cells in lung disease: progress and pitfalls. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Concise Review: Using Fat to Fight Disease: A Systematic Review of Nonhomologous Adipose-Derived Stromal/Stem Cell Therapies. [2022]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of MSC Cell Therapies for Hospitalized Patients with COVID-19: A Systematic Review and Meta-Analysis. [2022]

9. 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]

10. China pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Stem cell therapy for chronic lung diseases: hope and reality. [2010]