Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients (UCMSC-COPD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Genetic: Umbilical Cord Mesenchymal Stem Cells; Drug: Normal saline placebo

Detailed Description

This study is a randomized, double-blind, placebo-controlled clinical trial investigating the use of UC-MSCs as an adjuvant treatment for patients with Group E Chronic Obstructive Pulmonary Disease (COPD).

The rationale is based on the potential regenerative, anti-inflammatory, and immunomodulatory properties of mesenchymal stem cells, which have shown promising results in preclinical models of lung injury and early-phase COPD trials.

All participants receive their usual triple inhalation therapy and are randomly assigned to receive either UC-MSCs or placebo.

The UC-MSCs are administered intravenously on Day 1 and Day 21. The stem cells are prepared by a certified GMP-compliant facility (PT Prostem, Indonesia), and quality control includes sterility testing and flow cytometry-based characterization.

The protocol includes scheduled clinical, laboratory, functional, and radiological assessments to monitor treatment response and safety.

Follow-up spans 12 months, with particular focus on pulmonary function test, quality of life, exercise tolerance, and inflammation biomarkers.

This study is conducted at Persahabatan Hospital, Indonesia, in collaboration with PT Prostem, Indonesia.

The findings are expected to contribute to the clinical evidence base for cell-based therapies in chronic respiratory diseases and may inform future large-scale trials or translational applications.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Special Capital Region
    • Jakarta, Jakarta Special Capital Region, Indonesia, 13230
      • Recruiting
      • Persahabatan Hospital
      • Contact: Heidy Agustin, Pulmonologist; Phone Number: +62 816-1147-386; Email: heidy_agst@yahoo.com
      • Contact: Triya Damayanti, Pulmonologist; Phone Number: +62 812-9463-3437; Email: tria_94@yahoo.com
      • Principal Investigator: Triya Damayanti, Pulmonologist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Umbilical Cord Mesenchymal Stem Cells Group; Participants receive intravenous infusion of umbilical cord-derived mesenchymal stem cells (1 million cells/kg body weight) on Day 1 and Day 21, in addition to standard COPD therapy.	Genetic: Umbilical 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.; Other Names: UC-MSCs; Mesenchymal Stromal Cells from Umbilical Cord
Placebo Comparator: Placebo Group; Participants receive intravenous infusion of 100 mL normal saline (placebo) on Day 1 and Day 21, in addition to standard COPD therapy.	Drug: Normal saline placebo; 100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Forced Expiratory Volume in 1 second (FEV₁)	Forced Expiratory Volume in 1 second (FEV₁) is a key physiological parameter reflecting the degree of airflow limitation in chronic obstructive pulmonary disease (COPD). FEV₁ is measured using standardized spirometry according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines and reported in milliliters (mL). The primary efficacy endpoint is defined as the change in FEV₁ from baseline following administration of the study product in addition to standard therapy.	Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
Change in Forced Vital Capacity (FVC)	Forced Vital Capacity (FVC) represents the maximal volume of air exhaled forcefully after full inspiration. These parameters are measured by spirometry following ATS/ERS standards and provide complementary information on ventilatory mechanics and disease severity beyond FEV₁ alone.	Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
Change in FEV₁/FVC ratio	FEV₁/FVC ratio is used to quantify the severity of airflow obstruction. These parameters are measured by spirometry following ATS/ERS standards and provide complementary information on ventilatory mechanics and disease severity beyond FEV₁ alone.	Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO, % predicted)	DLCO is measured using the single-breath technique in accordance with ATS guidelines to evaluate pulmonary gas exchange capacity and alveolar-capillary membrane function.	Baseline; 3 months, 6 months, and 12 months after the second study product infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in COPD Assessment Test (CAT) score	The COPD Assessment Test (CAT) is a validated patient-reported outcome instrument used to assess health-related quality of life in patients with COPD.	Baseline; 1 month, 3 months, 6 months, and 12 months after the second study product infusion
Change in Modified Medical Research Council (mMRC) dyspnea scale	The mMRC dyspnea scale is used to assess functional limitation due to breathlessness during daily activities.	Baseline; 1 month, 3 months, 6 months, and 12 months after the second study product infusion
Change in serum cytokine levels (IL-1β, IL-6, TNF-α, IL-10)	Serum cytokine levels are measured to explore immunomodulatory effects of the study intervention and will be reported in picograms per mililiter(pg/mL)	Baseline; 1 month, 3 months, and 12 months after the second study product infusion
Change in Six-Minute Walk Test (6MWT)	Functional exercise capacity is assessed using the Six-Minute Walk Test (6MWT) performed according to ATS guidelines and will be reported in meter (M)	Baseline; 3 months, 6 months, and 12 months after the second study product infusion
Incidence of adverse events (AEs) and serious adverse events (SAEs)	Safety is assessed through monitoring of adverse events and serious adverse events throughout the study period.	From the first study product infusion until 12 months after the second infusion.

Collaborators and Investigators

• Sponsor: RSUP Persahabatan
• Collaborators: PT. Prodia Stem Cell Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 126.A.1/KEPK-RSUPP/02/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No