Actively Recruiting
Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
Led by RSUP Persahabatan · Updated on 2026-02-27
20
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
R
RSUP Persahabatan
Lead Sponsor
P
PT. Prodia Stem Cell Indonesia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Persahabatan Hospital
Jakarta, Jakarta Special Capital Region, Indonesia, 13230
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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