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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Umc119-06-05 Intravenous Infusion For The Treatment Of Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease

Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells (NCT06491043) is a Phase 2 interventional studying Chronic Obstructive Pulmonary Disease, sponsored by Meribank Biotech Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This phase II study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD. Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chronic Obstructive Pulmonary Disease 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.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Obstructive Pulmonary Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Between ≥40 and ≤80 years of age, of either sex and of any race. 2. With diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standard. 3. Has a post-bronchodilator FEV1/FVC ratio \<0.70. 4. Has a post-bronchodilator FEV1 predicted value ≥30% and \<80%. 5. With a score ≥2 in the mMRC dyspnea scale. 6. With a score ≥10 in the COPD Assessment Test (CAT). 7. With a body weight ≥40 to ≤90 kg. 8. The disease status of COPD has been stable as determined by the investigator, and the standard treatment for COPD was not adjusted within 3 months prior to screening. 9. Is a current or ex-smoker, with a cigarette smoking history of ≥10 years or \>10 pack-years. 10. Women of child-bearing potential should have a negative urine pregnancy test at screening, UNLESS they meet the following criteria: (1)Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with the serum follicle stimulating hormone (FSH) level \>40 mIU/mL, OR; (2)6 weeks post-surgical bilateral oophorectomy with or without hysterectomy 11.Heterosexually active subjects must agree to use a double barrier method of birth control (or must have been surgically sterilized/post-menopausal) and not to donate sperms/eggs during the study. 12.Willing to provide written willing to sign a consent form to participate in the study. Who Should NOT Join This Trial: 1. Has evidence of active malignancy or prior history of active malignancy that has not been in complete remission for at least 5 years prior to screening. 2. Diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g., restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer). 3. Has initiated pulmonary rehabilitation (e.g., exercise training) within 3 months prior to screening which, in the opinion of the Principal Investigator (PI), may affect the study's results. ...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: 1. Between ≥40 and ≤80 years of age, of either sex and of any race. 2. With diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standard. 3. Has a post-bronchodilator FEV1/FVC ratio \<0.70. 4. Has a post-bronchodilator FEV1 predicted value ≥30% and \<80%. 5. With a score ≥2 in the mMRC dyspnea scale. 6. With a score ≥10 in the COPD Assessment Test (CAT). 7. With a body weight ≥40 to ≤90 kg. 8. The disease status of COPD has been stable as determined by the investigator, and the standard treatment for COPD was not adjusted within 3 months prior to screening. 9. Is a current or ex-smoker, with a cigarette smoking history of ≥10 years or \>10 pack-years. 10. Women of child-bearing potential should have a negative urine pregnancy test at screening, UNLESS they meet the following criteria: (1)Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with the serum follicle stimulating hormone (FSH) level \>40 mIU/mL, OR; (2)6 weeks post-surgical bilateral oophorectomy with or without hysterectomy 11.Heterosexually active subjects must agree to use a double barrier method of birth control (or must have been surgically sterilized/post-menopausal) and not to donate sperms/eggs during the study. 12.Willing to provide written informed consent to participate in the study. Exclusion Criteria: 1. Has evidence of active malignancy or prior history of active malignancy that has not been in complete remission for at least 5 years prior to screening. 2. Diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g., restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer). 3. Has initiated pulmonary rehabilitation (e.g., exercise training) within 3 months prior to screening which, in the opinion of the Principal Investigator (PI), may affect the study's results. 4. Has documented history of uncontrolled heart failure. 5. Has pulmonary hypertension due to left heart condition. 6. Has atrial fibrillation or significant congenital heart defect/disease. 7. Has had a moderate or severe exacerbation of COPD (defined by GOLD standard) or has required mechanical ventilation (not including continuous positive airway pressure \[CPAP\]) within 30 days prior to screening. 8. Is hospitalized at screening. 9. With current active infection including pulmonary infection, systemic infection, or severe local infections. 10. Have the following conditions in laboratory tests at screening: 1. \>2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or 2. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2; or 3. White blood cells (WBC) \<3.6 × 103/μL; or 4. Platelet counts \<150 × 103/μL; or 5. Hemoglobin \<10 g/dL; or 6. Spot urine albumin-creatinine ratio (UACR) ≥30 mg/g; or 7. Clinically significant hematuria or proteinuria deemed by the study investigator. 11. With known stage ≥3 chronic kidney disease. 12. Received systemic steroids or other immunosuppressants, immunomodulators, cytotoxic agents, chemotherapy, radiation therapy, or other cell therapies within 28 days or 5 half-lives, whichever is longer, prior to screening. 13. With known alpha-1 antitrypsin deficiency. 14. With known allergy or hypersensitivity to any component of the investigational product (IP) formulation (normal saline and human serum albumin \[HSA\]). 15. With a known history of drug-related anaphylaxis or other severe allergic reactions to drug. Note: "Severe" is defined as Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 3 or greater. 16. Underwent major surgery (body organs that require anesthesia, such as tumor removal, open chest, heart surgery, abdominal surgery, intracranial surgery, or normal surgery for more than 3 hours, etc.) within 30 days prior to screening. 17. With known human immunodeficiency virus infection or immunocompromised. 18. With a known history of alcohol abuse or drug abuse within 5 years prior to screening. 19. Participating in another clinical study of new investigational therapies or have received an investigational therapy within 3 months prior to screening. 20. Pregnant (or plan to become pregnant within 3 months after study treatment) or lactating. 21. Has a life expectancy of \<6 months.

Treatments Being Tested

OTHER

UMC119-06-05

Human Umbilical Cord Derived-Mesenchymal Stem Cells

Locations (2)

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.

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, Taiwan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06491043), the sponsor (Meribank Biotech Co., Ltd.), 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 NCT06491043 clinical trial studying?

This phase II study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD. Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06491043?

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 NCT06491043?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

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.

Source: ClinicalTrials.gov API v2 record for NCT06491043. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06491043. 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 2026-05-08 · Data from ClinicalTrials.gov.