Stem Cell Therapy for Lung Disease
(ADcSVF-COPD Trial)
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.12345Why 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.23467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pulmonary function tests and other evaluations.
What Are the Treatments Tested in This Trial?
Interventions
- AD-cSVF
Find a Clinic Near You
Who Is Running the Clinical Trial?
Healeon Medical Inc
Lead Sponsor
Terry, Glenn C., M.D.
Collaborator