RecruitingPhase 2NCT06491043

Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Umc119-06-05 Intravenous Infusion For The Treatment Of Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease


Sponsor

Meribank Biotech Co., Ltd.

Enrollment

90 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD. Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing intravenous infusions of stem cells (called mesenchymal stem cells, donated from healthy people) in people with moderate to severe COPD (chronic obstructive pulmonary disease). Researchers hope these stem cells can reduce inflammation and potentially slow lung function decline. **You may be eligible if...** - You are 40 to 80 years old with a confirmed COPD diagnosis - Your lung function test shows a FEV1 between 30% and 80% of normal - You have significant breathlessness and your disease has been stable for at least 3 months - You are a current or former smoker with at least 10 pack-years of smoking history **You may NOT be eligible if...** - You have had a COPD flare-up requiring hospitalization in the past 3 months - You have cancer or active autoimmune disease - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUMC119-06-05

Human Umbilical Cord Derived-Mesenchymal Stem Cells


Locations(2)

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan City, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06491043


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