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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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.

Key facts

Study ID

NCT07441226

Run by

RSUP Persahabatan

People needed

20

Starts

2025-08-08

Expected to finish

2028-01-01

Last updated by the study team

2026-02-27

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 40 to 75 years.
• Diagnosed with Group E Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2023 criteria.
• Receiving triple inhalation therapy (long-acting beta-agonist, inhaled corticosteroid, long-acting muscarinic antagonist) for at least 6 months prior to enrollment.
• Clinically stable for at least 2 weeks prior to enrollment.
• Provided written informed consent to participate in the study.

You may not qualify if…

• Current smoker or stopped smoking less than 6 months prior to screening.
• Acute exacerbation of COPD within 2 weeks prior to enrollment.
• Diagnosis of pulmonary diseases other than COPD, including tuberculosis, pulmonary embolism, pneumothorax, multiple bullae, asthma, interstitial lung disease, or lung cancer.
• History of tuberculosis within the past 10 years.
• Active infection (including HIV positive).
• Malignancy of any type.
• Severe cardiac disease, including congestive heart failure classified as NYHA class III or IV, significant arrhythmias, valvular heart disease, cardiomyopathy, or congenital heart disease.
• Severe hepatic dysfunction (SGOT, SGPT, or bilirubin levels >2 times upper limit of normal).
• Severe renal dysfunction (serum creatinine >1.5 times upper limit of normal).
• Pregnant or breastfeeding.
• Comorbid conditions that may affect survival (e.g., advanced diabetes mellitus with HbA1c >7%, recent myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis).
• Leukopenia (white blood cell count <4×10⁹/L) or agranulocytosis (white blood cell count <1.5×10⁹/L or neutrophils <0.5×10⁹/L).
• History of psychiatric illness, epilepsy, or other central nervous system disorders.
• History of alcohol or drug abuse.
• Participation in another clinical trial within 3 months prior to enrollment.
• Poor adherence to prior medical care or expected difficulty completing the study protocol.
• Inability to perform spirometry maneuvers.
• Life expectancy less than 6 months due to comorbid conditions.
• Use of immunosuppressive therapy within 8 months prior to screening.

Where it is running

• Persahabatan Hospital — Jakarta, Jakarta Special Capital Region, Indonesia (enrolling)

Full record on ClinicalTrials.gov

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