Clinical Research Directory
Browse clinical research sites, groups, and studies.
Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
Sponsor: RSUP Persahabatan
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.
Official title: A Randomized, Double-Blind, Controlled Trial of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-08-08
Completion Date
2028-01
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Umbilical Cord Mesenchymal Stem Cells
Umbilical cord mesenchymal stem cells provided by PT Prostem (GMP-certified facility), diluted in 100 mL normal saline, administered intravenously at 20 mL/hour.
Normal saline placebo
100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention.
Locations (1)
Persahabatan Hospital
Jakarta, Jakarta Special Capital Region, Indonesia