RecruitingPhase 2NCT07441226

Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients

A Randomized, Double-Blind, Controlled Trial of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients


Sponsor

RSUP Persahabatan

Enrollment

20 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the efficacy and safety of allogeneic human UC-MSC to treat stage E Chronic Obstructive Pulmonary Disease (COPD). All participants in this study already receive standard treatment for COPD, which includes triple inhaled medications with LABA, LAMA and ICS. We hypothesize that UC-MSCs will improve COPD management. UC-MSCs are prepared in a certified laboratory and given intravenously. For 12 months from day 0, all patients will be observed for comprehensive safety evaluation, pulmonary function testing (PFT), quality of life indicators including questionnaires, 6-min walk test (6MWT), and inflammation biomarkers.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding umbilical cord-derived stem cells to standard treatment can help people with severe, hard-to-control COPD (chronic obstructive pulmonary disease — a lung condition that makes breathing difficult). The stem cells are given as an add-on therapy to the usual inhaler combination. **You may be eligible if...** - You are between 40 and 75 years old - You have severe COPD classified as "Group E" (the most advanced category with frequent flare-ups) - You have been on a triple-inhaler therapy (a combination of three types of inhalers) for at least 6 months - Your condition has been stable for at least 2 weeks **You may NOT be eligible if...** - You are a current smoker, or quit less than 6 months ago - You had a COPD flare-up in the last 2 weeks - You have another lung condition such as tuberculosis, asthma, or lung cancer - You have HIV or another active infection - You have any type of cancer - You have severe heart, liver, or kidney disease - You are pregnant or breastfeeding - You are taking immunosuppressive medications - You have a psychiatric condition, history of alcohol or drug abuse - Your life expectancy is less than 6 months due to other illnesses 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

GENETICUmbilical Cord Mesenchymal Stem Cells

Umbilical cord mesenchymal stem cells provided by PT Prostem (GMP-certified facility), diluted in 100 mL normal saline, administered intravenously at 20 mL/hour.

DRUGNormal saline placebo

100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention.


Locations(1)

Persahabatan Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

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NCT07441226


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