Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
Recruiting · NCT07441226 · Interventional (participants receive a specific treatment) · Lead sponsor: RSUP Persahabatan
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
1 location listed.
- Persahabatan Hospital - Jakarta, Jakarta Special Capital Region, Indonesia