Umbilical Cord Stem Cells Added to Usual Treatment for Severe COPD
Tests umbilical cord stem cells alongside usual inhaled medicines in adults with severe COPD.
Plain-language title generated from the registry record
Registry title: Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
Key facts
- Where
- Jakarta, IndonesiaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Source: NCT07441226, who can take part
Where in Indonesia
- Persahabatan HospitalJakarta, IndonesiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RSUP Persahabatan
- Trial code
- NCT07441226
- Record updated
- 27 February 2026
- Original description
This study aims to evaluate the efficacy and safety of allogeneic human UC-MSC to treat stage E Chronic Obstructive Pulmonary Disease (COPD).Read full original descriptionShow less
A Randomized, Double-Blind, Controlled Trial of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
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.
Inclusion: 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: Current smoker or stopped smoking less than 6 months prior to screening; Acute exacerbation of COPD within 2 weeks prior to enrollment; Participation in another clinical trial within 3 months prior to enrollment; Poor adherence to prior medical care or expected difficulty completing the study protocol; Use of immunosuppressive therapy within 8 months prior to screening; 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; History of psychiatric illness, epilepsy, or other central nervous system disorders; History of alcohol or drug abuse; Life expectancy less than 6 months due to comorbid conditions; 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); 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); Pregnant or breastfeeding; Inability to perform spirometry maneuvers.