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

NCT07441226 | Recruiting Phase 2 DMC

• 1 other identifier: 126.A.1/KEPK-RSUPP/02/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in COPD Assessment Test (CAT) score

  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

  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)

  Baseline; 1 month, 3 months, and 12 months after the second study product infusion

• Change in Six-Minute Walk Test (6MWT)

  Baseline; 3 months, 6 months, and 12 months after the second study product infusion

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  From the first study product infusion until 12 months after the second infusion.

Study Arms (2)

Umbilical Cord Mesenchymal Stem Cells Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Umbilical Cord Mesenchymal Stem Cells GENETIC

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

Also known as: UC-MSCs, Mesenchymal Stromal Cells from Umbilical Cord

Umbilical Cord Mesenchymal Stem Cells Group

Normal saline placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• RSUP Persahabatan: lead
• PT. Prodia Stem Cell Indonesia: collaborator

Study Sites (1)

Persahabatan Hospital

Jakarta, Jakarta Special Capital Region, 13230, Indonesia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 27, 2026
• Study Start: August 8, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

ID (1)