Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorRSUP Persahabatan
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Umbilical Cord Mesenchymal Stem Cells
- Normal saline placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
RSUP Persahabatan
Lead sponsor
PT. Prodia Stem Cell Indonesia
Collaborator
Source ClinicalTrials.gov