Mesenchymal Stem Cells for COPD

Overseen By Torsak Vimoktayon

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment Mesenchymal Stem Cells for COPD?

Research shows that mesenchymal stem cells (MSCs) can reduce inflammation and promote tissue repair in lung diseases like COPD. Studies in mice have shown that MSCs can help repair lung tissue and improve lung function, and early human studies suggest they may be safe and effective for COPD. ^{1 2 3 4 5}

Is it safe to use mesenchymal stem cells for treating COPD?

Research shows that using mesenchymal stem cells (MSCs) for various conditions, including COPD, appears to be generally safe. The most common side effect reported is a temporary fever, and studies continue to support the safety of MSCs in clinical trials. ^{2 6 7 8 9}

How is the treatment with Mesenchymal Stem Cells different from other treatments for COPD?

Mesenchymal Stem Cells (MSCs) are unique because they can migrate to sites of inflammation and help repair tissue, which is different from standard COPD treatments that mainly focus on reducing symptoms. MSCs have the potential to regenerate lung tissue and modulate the immune response, offering a novel approach to treating COPD. ^{2 10 11 12 13}

Research Team

Jorge M Mallea, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Age range: at least 18 years of age

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Subjects with Advanced Chronic Obstructive Pulmonary Disease Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A phase I study for intravenous autologous mesenchymal stromal cell administration to patients with severe emphysema. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Allogeneic umbilical cord-derived mesenchymal stem cell transplantation for treating chronic obstructive pulmonary disease: a pilot clinical study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cells. [2018]

4. China pubmed.ncbi.nlm.nih.gov

MSCs relieve lung injury of COPD mice through promoting proliferation of endogenous lung stem cells. [2018]

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

TNF-α and IL-1β-activated human mesenchymal stromal cells increase airway epithelial wound healing in vitro via activation of the epidermal growth factor receptor. [2018]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A placebo-controlled, randomized trial of mesenchymal stem cells in COPD. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Roles of Mesenchymal Cells in the Lung: From Lung Development to Chronic Obstructive Pulmonary Disease. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Human nasal mucosa contains tissue-resident immunologically responsive mesenchymal stromal cells. [2018]

12. Italy pubmed.ncbi.nlm.nih.gov

Molecular changes of mesenchymal stromal cells in response to dexamethasone treatment. [2018]

13. Italy pubmed.ncbi.nlm.nih.gov

[Mesenchymal stem cells and bone regeneration]. [2018]