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RECRUITING
NCT07441226
PHASE2

Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients

Sponsor: RSUP Persahabatan

View on ClinicalTrials.gov

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

GENETIC

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.

DRUG

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