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

NCT07441226 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

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.

Sponsors & Collaborators

  • PT. Prodia Stem Cell Indonesia

    collaborator INDUSTRY

  • RSUP Persahabatan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-08
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441226 on ClinicalTrials.gov