Health TrialsbyHealthPanel

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

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorRSUP Persahabatan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Umbilical Cord Mesenchymal Stem Cells

    Genetic

    Umbilical cord mesenchymal stem cells provided by PT Prostem (GMP-certified facility), diluted in 100 mL normal saline, administered intravenously at 20 mL/hour.

  • Normal saline placebo

    Drug

    100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Umbilical Cord Mesenchymal Stem Cells GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Forced Expiratory Volume in 1 second (FEV₁)

Forced Expiratory Volume in 1 second (FEV₁) is a key physiological parameter reflecting the degree of airflow limitation in chronic obstructive pulmonary disease (COPD). FEV₁ is measured using standardized spirometry according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines and reported in milliliters (mL). The primary efficacy endpoint is defined as the change in FEV₁ from baseline following administration of the study product in addition to standard therapy.

Time frame
Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
2

Change in Forced Vital Capacity (FVC)

Forced Vital Capacity (FVC) represents the maximal volume of air exhaled forcefully after full inspiration. These parameters are measured by spirometry following ATS/ERS standards and provide complementary information on ventilatory mechanics and disease severity beyond FEV₁ alone.

Time frame
Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
3

Change in FEV₁/FVC ratio

FEV₁/FVC ratio is used to quantify the severity of airflow obstruction. These parameters are measured by spirometry following ATS/ERS standards and provide complementary information on ventilatory mechanics and disease severity beyond FEV₁ alone.

Time frame
Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
4

Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO, % predicted)

DLCO is measured using the single-breath technique in accordance with ATS guidelines to evaluate pulmonary gas exchange capacity and alveolar-capillary membrane function.

Time frame
Baseline; 3 months, 6 months, and 12 months after the second study product infusion

Secondary outcomes

1

Change in COPD Assessment Test (CAT) score

The COPD Assessment Test (CAT) is a validated patient-reported outcome instrument used to assess health-related quality of life in patients with COPD.

Time frame
Baseline; 1 month, 3 months, 6 months, and 12 months after the second study product infusion
2

Change in Modified Medical Research Council (mMRC) dyspnea scale

The mMRC dyspnea scale is used to assess functional limitation due to breathlessness during daily activities.

Time frame
Baseline; 1 month, 3 months, 6 months, and 12 months after the second study product infusion
3

Change in serum cytokine levels (IL-1β, IL-6, TNF-α, IL-10)

Serum cytokine levels are measured to explore immunomodulatory effects of the study intervention and will be reported in picograms per mililiter(pg/mL)

Time frame
Baseline; 1 month, 3 months, and 12 months after the second study product infusion
4

Change in Six-Minute Walk Test (6MWT)

Functional exercise capacity is assessed using the Six-Minute Walk Test (6MWT) performed according to ATS guidelines and will be reported in meter (M)

Time frame
Baseline; 3 months, 6 months, and 12 months after the second study product infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RSUP Persahabatan

Lead sponsor

PT. Prodia Stem Cell Indonesia

Collaborator

Source ClinicalTrials.gov
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