Umbilical cord stem cell therapy added to standard care for Group E COPD.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial testing allogeneic umbilical cord mesenchymal stem cells (UC-MSCs) as an add-on to standard triple inhaler therapy in Group E COPD patients. Participants are randomly assigned to receive UC-MSCs or saline placebo given intravenously on Day 1 and Day 21, with follow-up visits over 12 months. Outcomes include pulmonary function tests, 6-minute walk distance, quality-of-life questionnaires, inflammatory biomarkers, and comprehensive safety monitoring. The trial is conducted at Persahabatan Hospital in Jakarta with cells prepared under GMP-like conditions by a local certified facility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Persahabatan Hospital
  Jakarta, Jakarta Special Capital Region, Indonesia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.