Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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A Randomized, Double-Blind, Controlled Trial of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug, Genetic
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
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• Adults aged 40 to 75 years.

• Diagnosed with Group E Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2023 criteria.

• Receiving triple inhalation therapy (long-acting beta-agonist, inhaled corticosteroid, long-acting muscarinic antagonist) for at least 6 months prior to enrollment.

• Clinically stable for at least 2 weeks prior to enrollment.

• Provided written informed consent to participate in the study.

Locations
Other Locations
Indonesia
Persahabatan Hospital
RECRUITING
Jakarta
Time Frame
Start Date: 2025-08-08
Estimated Completion Date: 2028-01
Participants
Target number of participants: 20
Treatments
Experimental: Umbilical Cord Mesenchymal Stem Cells Group
Participants receive intravenous infusion of umbilical cord-derived mesenchymal stem cells (1 million cells/kg body weight) on Day 1 and Day 21, in addition to standard COPD therapy.
Placebo_comparator: Placebo Group
Participants receive intravenous infusion of 100 mL normal saline (placebo) on Day 1 and Day 21, in addition to standard COPD therapy.
Sponsors
Collaborators: PT. Prodia Stem Cell Indonesia
Leads: RSUP Persahabatan

This content was sourced from clinicaltrials.gov