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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Umbilical cord mesenchymal stem cells provided by PT Prostem (GMP-certified facility), diluted in 100 mL normal saline, administered intravenously at 20 mL/hour.
100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention.
Persahabatan Hospital
Jakarta, Jakarta Special Capital Region, Indonesia
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; 3 months, 6 months, and 12 months after the second study product infusion
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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: From the first study product infusion until 12 months after the second infusion.
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