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

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.