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

Official title

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

Overview

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.

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.

Primary outcome measures

• Change in Forced Expiratory Volume in 1 second (FEV₁) [Time frame: Baseline; 3 months, 6 months, and 12 months after the second study product infusion.]
• Change in Forced Vital Capacity (FVC) [Time frame: Baseline; 3 months, 6 months, and 12 months after the second study product infusion.]
• Change in FEV₁/FVC ratio [Time frame: Baseline; 3 months, 6 months, and 12 months after the second study product infusion.]
• Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO, % predicted) [Time frame: Baseline; 3 months, 6 months, and 12 months after the second study product infusion]

Secondary outcome measures (5)

• Change in COPD Assessment Test (CAT) score [Time frame: Baseline; 1 month, 3 months, 6 months, and 12 months after the second study product infusion]
• Change in Modified Medical Research Council (mMRC) dyspnea scale [Time frame: Baseline; 1 month, 3 months, 6 months, and 12 months after the second study product infusion]
• Change in serum cytokine levels (IL-1β, IL-6, TNF-α, IL-10) [Time frame: Baseline; 1 month, 3 months, and 12 months after the second study product infusion]
• Change in Six-Minute Walk Test (6MWT) [Time frame: Baseline; 3 months, 6 months, and 12 months after the second study product infusion]
• Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time frame: From the first study product infusion until 12 months after the second infusion.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Current smoker or stopped smoking less than 6 months prior to screening.
• Acute exacerbation of COPD within 2 weeks prior to enrollment.
• Diagnosis of pulmonary diseases other than COPD, including tuberculosis, pulmonary embolism, pneumothorax, multiple bullae, asthma, interstitial lung disease, or lung cancer.
• History of tuberculosis within the past 10 years.
• Active infection (including HIV positive).
• Malignancy of any type.
• Severe cardiac disease, including congestive heart failure classified as NYHA class III or IV, significant arrhythmias, valvular heart disease, cardiomyopathy, or congenital heart disease.
• Severe hepatic dysfunction (SGOT, SGPT, or bilirubin levels >2 times upper limit of normal).
• Severe renal dysfunction (serum creatinine >1.5 times upper limit of normal).
• Pregnant or breastfeeding.
• Comorbid conditions that may affect survival (e.g., advanced diabetes mellitus with HbA1c >7%, recent myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis).
• Leukopenia (white blood cell count <4×10⁹/L) or agranulocytosis (white blood cell count <1.5×10⁹/L or neutrophils <0.5×10⁹/L).
• History of psychiatric illness, epilepsy, or other central nervous system disorders.
• History of alcohol or drug abuse.
• Participation in another clinical trial within 3 months prior to enrollment.
• Poor adherence to prior medical care or expected difficulty completing the study protocol.
• Inability to perform spirometry maneuvers.
• Life expectancy less than 6 months due to comorbid conditions.
• Use of immunosuppressive therapy within 8 months prior to screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Indonesia · 1 center

• Persahabatan Hospital — Jakarta

Identifiers

NCT: NCT07441226 · 126.A.1/KEPK-RSUPP/02/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗