NCT07441226

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RSUP Persahabatan · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, double-blind, placebo-controlled clinical trial investigating the use of UC-MSCs as an adjuvant treatment for patients with Group E Chronic Obstructive Pulmonary Disease (COPD). The rationale is based on the potential regenerative, anti-inflammatory, and immunomodulatory properties of mesenchymal stem cells, which have shown promising results in preclinical models of lung injury and early-phase COPD trials. All participants receive their usual triple inhalation therapy and are randomly assigned to receive either UC-MSCs or placebo. The UC-MSCs are administered intravenously on Day 1 and Day 21. The stem cells are prepared by a certified GMP-compliant facility (PT Prostem, Indonesia), and quality control includes sterility testing and flow cytometry-based characterization. The protocol includes scheduled clinical, laboratory, functional, and radiological assessments to monitor treatment response and safety. Follow-up spans 12 months, with particular focus on pulmonary function test, quality of life, exercise tolerance, and inflammation biomarkers. This study is conducted at Persahabatan Hospital, Indonesia, in collaboration with PT Prostem, Indonesia. The findings are expected to contribute to the clinical evidence base for cell-based therapies in chronic respiratory diseases and may inform future large-scale trials or translational applications.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-08
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Indonesia