Chronic Obstructive Pulmonary Disease (COPD)Phase 2UCMSC-COPDNCT07441226
Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
A Phase 2 study testing Umbilical Cord Mesenchymal Stem Cells in people with Chronic Obstructive Pulmonary Disease (COPD), run by RSUP Persahabatan at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Umbilical Cord Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Aug 2025to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Persahabatan Hospital
Jakarta, Jakarta Special Capital Region, 13230
Heidy Agustin, Pulmonologist, +62 816-1147-386, heidy_agst@yahoo.com
Triya Damayanti, Pulmonologist, +62 812-9463-3437, tria_94@yahoo.com
About this study
Official title: A Randomized, Double-Blind, Controlled Trial of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
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.
Read the 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.
- Being tested
- Umbilical Cord Mesenchymal Stem Cells, Normal saline placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Mesenchymal Stem CellsGenetic
Also called UC-MSCs, Mesenchymal Stromal Cells from Umbilical Cord
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 placeboDrug
100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells Group | Experimental | 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. Receives: Genetic: Umbilical Cord Mesenchymal Stem Cells |
| Placebo Group | Placebo comparator | Participants receive intravenous infusion of 100 mL normal saline (placebo) on Day 1 and Day 21, in addition to standard COPD therapy. Receives: Drug: Normal saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
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.
Measured: Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
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.
Measured: 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)
DLCO is measured using the single-breath technique in accordance with ATS guidelines to evaluate pulmonary gas exchange capacity and alveolar-capillary membrane function.
Measured: Baseline; 3 months, 6 months, and 12 months after the second study product infusion
Secondary outcomes (5)
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.
Measured: 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
The mMRC dyspnea scale is used to assess functional limitation due to breathlessness during daily activities.
Measured: 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)
Serum cytokine levels are measured to explore immunomodulatory effects of the study intervention and will be reported in picograms per mililiter(pg/mL)
Measured: Baseline; 1 month, 3 months, and 12 months after the second study product infusion
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)
Measured: Baseline; 3 months, 6 months, and 12 months after the second study product infusion
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Safety is assessed through monitoring of adverse events and serious adverse events throughout the study period.
Measured: From the first study product infusion until 12 months after the second infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start8 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RSUP Persahabatan
- Sponsor type
- University, hospital or other
- Collaborators
- PT. Prodia Stem Cell Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441226
- Sponsor's protocol ID
- 126.A.1/KEPK-RSUPP/02/2025
- Acronym
- UCMSC-COPD
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Trial of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients
- ClinicalTrials.gov ID
- NCT07441226
- Acronym / sponsor ID
- UCMSC-COPD / 126.A.1/KEPK-RSUPP/02/2025
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RSUP PersahabatanUniversity, hospital or other
- Collaborators
- PT. Prodia Stem Cell Indonesia
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells Group | Experimental | Genetic: Umbilical Cord Mesenchymal Stem CellsParticipants 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 Group | Placebo comparator | Drug: Normal saline placeboParticipants receive intravenous infusion of 100 mL normal saline (placebo) on Day 1 and Day 21, in addition to standard COPD therapy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Mesenchymal Stem CellsAlso: UC-MSCs, Mesenchymal Stromal Cells from Umbilical CordUmbilical cord mesenchymal stem cells provided by PT Prostem (GMP-certified facility), diluted in 100 mL normal saline, administered intravenously at 20 mL/hour. | Genetic | Umbilical Cord Mesenchymal Stem Cells Group |
| Normal saline placebo100 mL normal saline administered intravenously at 20 mL/hour, matching appearance and administration schedule of active intervention. | Drug | Placebo Group |
Primary outcome
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.
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.
Change in Forced Vital Capacity (FVC)
Time frame: Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
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.
Change in FEV₁/FVC ratio
Time frame: Baseline; 3 months, 6 months, and 12 months after the second study product infusion.
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.
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
DLCO is measured using the single-breath technique in accordance with ATS guidelines to evaluate pulmonary gas exchange capacity and alveolar-capillary membrane function.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Umbilical Cord Mesenchymal Stem Cells in people with Chronic Obstructive Pulmonary Disease (COPD), run by RSUP Persahabatan at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.