Stem Cell Therapy for Lung Disease

(ADcSVF-COPD Trial)

Not currently recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new stem cell treatment for Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes breathing difficult and causes coughing. It tests the safety and effectiveness of a specific stem cell therapy called AD-cSVF, derived from fat tissue. Participants will join one of three groups: one receiving the stem cells, another receiving the cells with a saline solution, and a third undergoing a procedure to collect fat tissue. Individuals diagnosed with moderate to severe COPD who experience symptoms like shortness of breath and coughing might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

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.

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

Research has shown that treatments using cells from fat tissue, known as adipose-derived stromal vascular fraction (AD-cSVF), are generally safe. In earlier studies, most participants did not experience serious side effects after receiving these cell infusions. For example, one study found these infusions safe, with no major problems reported for up to a year. However, some reports have noted blood clot-related issues after administering these cells throughout the body.

Overall, these findings suggest that AD-cSVF treatments are often well-tolerated, but like any treatment, potential risks exist. It's important to consider these factors and discuss them with healthcare professionals when considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about stem cell therapy for lung disease because it offers a fresh approach compared to existing treatments like bronchodilators and corticosteroids. Unlike these standard treatments that primarily focus on managing symptoms, the AD-cSVF therapy involves using cellular stem/stromal cells extracted from adipose tissue, which may help repair and regenerate lung tissue. This innovative mechanism targets the root cause of lung damage rather than just alleviating its symptoms. Additionally, the use of adipose-derived cells is promising due to their potential to differentiate into various cell types, offering a versatile and potentially more effective treatment option.

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

Research has shown that a treatment using cells from fat tissue, called AD-cSVF, may help with lung diseases. In this trial, participants will join different arms to evaluate the effects of AD-cSVF. Studies have found that these cells can lower inflammation and help repair lung tissue, potentially improving lung function. Early results suggest that introducing AD-cSVF into the lungs could alleviate symptoms like shortness of breath and enhance oxygen exchange. People who have received similar treatments reported easier breathing and less coughing. Although more research is needed, the initial findings are promising for conditions like COPD. ^{2 3 4 6 7}

Who Is on the Research Team?

Robert W Alexander, MD

Principal Investigator

Healeon Medical Inc

Glenn C. Terry, MD

Principal Investigator

Global Alliance for Regenerative Medicine (GARM)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3722100/

PMC - PubMed Central

To this end, we conducted a phase Ib, non-randomized, clinical trial to study the safety of three endobronchial infusions of autologous adipose derived stromal ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1465324924005681

Adipose-derived stromal vascular fraction cells to treat long ...

This study was designed to study the safety of AD SVF infused intravenously to treat the pulmonary symptoms of long COVID.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02216630

Safety and Efficacy of Adipose Derived Stem Cells for ...

In this study, we propose to investigate the immunosuppressive potential of the non-manipulated non-cultured stromal vascular fraction obtained via liposuction.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11088339/

Therapeutic application of adipose-derived stromal vascular ...

This study presents data on the possibility of using SVF, targeted regulation of its properties and reparative potential, as well as the results of research ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06940765?term=gid&viewType=Table&rank=6

Autologous Adipose-derived Stromal Vascular Fraction for ...

The GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5689766/

A Safety Assessment of Adipose‐Derived Cell Therapy in ...

This study reviewed the safety of adipose‐derived cell therapy. Thromboembolic complications were noted following systemic administration of cells.

7.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT02161744

Safety, Tolerability and Preliminary Efficacy of Adipose ...

The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose derived stem cells (aADSC) administered intravenously in patients ...