Mesenchymal Stem Cells for COPD

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Overseen ByTorsak Vimoktayon
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how mesenchymal stem cells might benefit individuals with severe chronic obstructive pulmonary disease (COPD), a lung condition that makes breathing difficult. Participants will receive an infusion of these stem cells to determine if their symptoms improve. Ideal candidates are ex-smokers who have experienced a significant COPD flare-up requiring treatment in the past year. This study targets those who can manage daily life with COPD but seek new treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity 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. However, if you are on immunosuppressive medications or have used prednisone or similar corticosteroids within 12 weeks before the study, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that certain stem cells, called mesenchymal stem cells (MSCs), might help treat long-term lung diseases like COPD (chronic obstructive pulmonary disease). Researchers have tested these stem cells for safety and their potential to improve lung health.

Animal studies have shown positive results, suggesting that MSCs can help with lung problems like emphysema. In human studies, MSCs have generally been safe, with most participants not experiencing serious side effects. Some mild reactions, such as fever or chills, have been reported, but these were uncommon.

Although this trial is in the early stages, MSCs have been studied for other health issues, providing some confidence in their safety. However, since using them for COPD is new, researchers are still learning about all the safety details. Participants should consider this when deciding whether to join the trial.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about using mesenchymal stem cells (MSCs) for treating chronic obstructive pulmonary disease (COPD) because this approach is fundamentally different from current treatments. Most existing COPD therapies, like bronchodilators and corticosteroids, focus on easing symptoms and managing inflammation. However, MSCs have the potential to repair and regenerate damaged lung tissue, addressing the root cause of the disease rather than just alleviating symptoms. Additionally, MSCs are administered intravenously, which allows them to travel throughout the body and potentially offer a systemic therapeutic effect, something current localized treatments don't provide. This novel mechanism of action is what makes MSCs a promising option for those with severe COPD.

What evidence suggests that mesenchymal stem cells might be an effective treatment for COPD?

Research has shown that certain stem cells, called mesenchymal stem cells (MSCs), might help treat chronic obstructive pulmonary disease (COPD). Studies have found that MSCs can balance the immune system and heal lung tissue. In lab and animal studies, MSCs have reduced inflammation and repaired damaged lung areas. These cells can regenerate tissue, offering hope for improving lung function in COPD patients. This trial will investigate the effects of MSCs in participants with severe or very severe COPD, who will receive intravenous MSC infusions. Although more research is needed in humans, early results suggest MSCs may provide relief for those with severe COPD.12678

Who Is on the Research Team?

JM

Jorge M Mallea, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults with advanced COPD who've had a flare-up in the last year, have quit smoking for at least six months, and have specific lung function test results. They must not be pregnant or breastfeeding, have a history of certain diseases like cancer or autoimmune disorders, recent infections requiring antibiotics, or severe heart issues.

Inclusion Criteria

You have not used any nicotine products for at least six months before joining the study.
You must have at least a score of 2 on the modified Medical Research Council (mMRC) scale.
You have had a serious worsening of your COPD in the past year that needed antibiotics or steroids.
See 12 more

Exclusion Criteria

Subject has or has had an active infection requiring systemic antibiotics within 12 weeks on enrollment in the study
Your body is very overweight (BMI over 35) or very underweight (BMI less than 16).
Subject is pregnant or breast-feeding
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusion of Mesenchymal Stem Cells (MSC) for treatment of severe or very severe COPD

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mesenchymal Stem Cells
Trial Overview The trial is exploring the effects of mesenchymal stem cells on patients with advanced chronic obstructive pulmonary disease (COPD) to see if this therapy can improve their lung function and quality of life.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Subjects with Advanced Chronic Obstructive Pulmonary DiseaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Published Research Related to This Trial

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.
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]

Citations

Mesenchymal stromal cells: a novel therapy for the ...In this review, we discuss the rationale for MSC-based cell therapy in COPD, the main findings from in vitro and in vivo preclinical COPD model studies.
Stem cell therapies for chronic obstructive pulmonary diseaseThis review summarizes the characteristics of various stem cell types and describes their therapeutic potential in the treatment of COPD, with a particular ...
Mesenchymal stem cells for lung diseasesChronic lung diseases, including chronic obstructive pulmonary disease (COPD) ... Mesenchymal stromal cell therapy for chronic lung diseases ...
Mesenchymal stem cell-derived exosomes–a promising ...Mesenchymal stem cell-derived exosomes–a promising therapeutic approach to improve neurocognitive disorders in chronic obstructive pulmonary ...
Mesenchymal stem cell application in pulmonary disease ...The therapeutic application of mesenchymal stem cells (MSCs), in addition to restoring immune homeostasis, can promote the regeneration of lung tissue.
Stem cell therapies for chronic obstructive pulmonary ...This review summarizes the characteristics of various stem cell types and describes their therapeutic potential in the treatment of COPD, with a particular ...
A Placebo-Controlled, Randomized Trial of Mesenchymal ...Preliminary results of this study were presented at the Stem Cells and Cell Therapies in Lung Biology and Diseases Conference, July 2011, Burlington, VT.
Mesenchymal stromal cell therapy in COPDPreclinical studies have demonstrated encouraging outcomes of MSCs therapy for lung disorders, including emphysema.
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