What side effects are associated with this type of intervention?

Common treatments for COPD with immunomodulatory, anti-inflammatory, and tissue repair effects include corticosteroids, phosphodiesterase-4 inhibitors, and theophylline. Corticosteroids can cause side effects such as increased risk of infections, osteoporosis, hyperglycemia, and adrenal suppression. Phosphodiesterase-4 inhibitors, like roflumilast, may lead to gastrointestinal issues, weight loss, and psychiatric symptoms. Theophylline can cause nausea, headaches, insomnia, and has a narrow therapeutic window, increasing the risk of toxicity. These side effects should be carefully considered when choosing a treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for COPD primarily include bronchodilators and inhaled corticosteroids, which help manage symptoms and reduce inflammation. Notable examples are combination therapies like LABA-ICS (Long-Acting Beta-Agonists and Inhaled Corticosteroids), such as salmeterol/fluticasone and vilanterol/fluticasone, which have shown efficacy in improving lung function and reducing exacerbations. While these treatments focus on symptom relief and inflammation control, investigational therapies like Mesenchymal Stem Cells aim to provide additional benefits through immunomodulation and tissue repair, which are not yet standard in current FDA-approved COPD treatments.

What other types of research exist?

Promising novel alternatives to Mesenchymal Stem Cells therapy for COPD patients include: 1) Bronchoscopic Lung Volume Reduction (BLVR) therapies, which have shown efficacy in reducing lung volume and improving respiratory function. 2) Biological Lung Volume Reduction (BLVR) using tissue engineering principles, which aims to reduce lung volume and improve lung mechanics. 3) Anti-fibrotic agents like nintedanib and pirfenidone, which are being explored for their potential to slow disease progression and reduce inflammation. 4) Gene therapy approaches targeting specific genetic mutations associated with COPD. 5) Exosome-based therapies, which leverage the paracrine effects of stem cells without the need for direct cell engraftment.

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Stem Cell Therapy

Mesenchymal Stem Cells for COPD

Phase 1

Waitlist Available

Led By Jorge M Mallea, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one hour post completion of infusion

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether mesenchymal stem cells therapy may help improve lung function for individuals with chronic obstructive pulmonary disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not detailed here, similar therapies may cause immune reactions, infection risks due to stem cell infusion, potential tissue damage at injection sites and allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one hour post completion of infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one hour post completion of infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour post completion of infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Side effects data

From 2021 Phase 1 & 2 trial • 10 Patients • NCT03356821

10%

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Mesenchymal Stem Cells

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with Advanced Chronic Obstructive Pulmonary DiseaseExperimental Treatment1 Intervention

Subjects diagnosed with severe or very severe COPD will be infused intravenously with Mesenchymal Stem Cells (MSC)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesenchymal Stem Cells

2016

Completed Phase 2

~240

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The main treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, and emerging therapies like mesenchymal stem cell (MSC) therapy. Bronchodilators relax the muscles around the airways, improving airflow and reducing symptoms like shortness of breath. Inhaled corticosteroids reduce inflammation in the airways, decreasing the frequency and severity of exacerbations. MSC therapy, which is still under investigation, aims to modulate the immune response, reduce inflammation, and promote tissue repair. These mechanisms are crucial for managing symptoms, reducing exacerbations, and potentially improving lung function and quality of life for COPD patients.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,353 Previous Clinical Trials

3,061,008 Total Patients Enrolled

Jorge M Mallea, MD4.04 ReviewsPrincipal Investigator - Mayo Clinic

Mayo Clinic

5Patient Review

I don't think I could heap enough praise on Dr. Mallea. They have an incredible wealth of knowledge and they're amazing with patients. I really don't think I'd be alive if it weren't for them.