Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
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.
Interventions
GENETICUmbilical 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.
DRUGNormal saline placebo
100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention.
Sponsors
RSUP Persahabatan
PT. Prodia Stem Cell Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Expiratory Volume in 1 second (FEV₁) | Baseline; 3 months, 6 months, and 12 months after the second study product infusion. | 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. |
| Change in Forced Vital Capacity (FVC) | Baseline; 3 months, 6 months, and 12 months after the second study product infusion. | 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. |
| Change in FEV₁/FVC ratio | Baseline; 3 months, 6 months, and 12 months after the second study product infusion. | 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. |
| Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO, % predicted) | Baseline; 3 months, 6 months, and 12 months after the second study product infusion | DLCO is measured using the single-breath technique in accordance with ATS guidelines to evaluate pulmonary gas exchange capacity and alveolar-capillary membrane function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in COPD Assessment Test (CAT) score | Baseline; 1 month, 3 months, 6 months, and 12 months after the second study product infusion | The COPD Assessment Test (CAT) is a validated patient-reported outcome instrument used to assess health-related quality of life in patients with COPD. |
| 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 | The mMRC dyspnea scale is used to assess functional limitation due to breathlessness during daily activities. |
| 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 | Serum cytokine levels are measured to explore immunomodulatory effects of the study intervention and will be reported in picograms per mililiter(pg/mL) |
| Change in Six-Minute Walk Test (6MWT) | Baseline; 3 months, 6 months, and 12 months after the second study product infusion | Functional exercise capacity is assessed using the Six-Minute Walk Test (6MWT) performed according to ATS guidelines and will be reported in meter (M) |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | From the first study product infusion until 12 months after the second infusion. | Safety is assessed through monitoring of adverse events and serious adverse events throughout the study period. |
Countries
Indonesia
Outcome results
None listed