Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
A Randomized, Double-Blind, Controlled Trial of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
RSUP Persahabatan
20 participants
Aug 8, 2025
INTERVENTIONAL
Conditions
Summary
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
Plain Language Summary
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Interventions
Umbilical cord mesenchymal stem cells provided by PT Prostem (GMP-certified facility), diluted in 100 mL normal saline, administered intravenously at 20 mL/hour.
100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention.
Locations(1)
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NCT07441226