Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Q: Who can participate in NCT07441226?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07441226?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy in Group E COPD Patients (NCT07441226) is a Phase 2 interventional studying Chronic Obstructive Pulmonary Disease (COPD), sponsored by RSUP Persahabatan. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chronic Obstructive Pulmonary Disease (COPD) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form to participate in the study. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Persahabatan Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07441226), the sponsor (RSUP Persahabatan), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07441226 clinical trial studying?

Who can participate in NCT07441226?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07441226?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT07441226. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07441226. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.