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

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

This trial will try two intravenous doses of umbilical cord mesenchymal stem cells alongside usual triple inhaler therapy to see if people aged 40–75 with Group E COPD have better lung function, exercise tolerance, and symptoms over 12 months.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: RSUP Persahabatan (Academic / other)
• Locations: 1 site (Jakarta, Jakarta Special Capital Region)
• Trial ID: NCT07441226 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 40–75 years old with Group E COPD who have been on stable triple inhaler therapy for at least 6 months, are clinically stable, have not smoked within the past 6 months, and meet other safety criteria are ideal candidates.

Not a fit: People with other active lung diseases, recent COPD exacerbations, current smoking, active infections, recent or active malignancy, or severe cardiac disease are unlikely to benefit or would be excluded from participation.

Why it matters

Potential benefit: If successful, this approach could reduce lung inflammation and improve lung function, exercise capacity, and quality of life for people with advanced COPD.

How similar studies have performed: Preclinical studies and small early-phase MSC trials have shown promising anti-inflammatory and safety signals, but clear, consistent clinical benefit in larger randomized COPD trials has not yet been established.

Eligibility criteria

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 this trial is running

Jakarta, Jakarta Special Capital Region

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

Conditions Chronic Obstructive Pulmonary Disease