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| Name | Class |
|---|---|
| PT. Prodia Stem Cell Indonesia | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Persahabatan Hospital | Recruiting | Jakarta | Jakarta Special Capital Region | 13230 | Indonesia |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Normal saline placebo | Drug | 100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention. |
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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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |