Infusion of stem cells to treat chronic obstructive pulmonary disease

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

This study is testing if an infusion of stem cells can help people with moderate to severe COPD breathe better and improve their overall health compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Meribank Biotech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (New Taipei City and 1 other locations)
• Trial ID: NCT06491043 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the safety and efficacy of UMC119-06-05, an allogenic mesenchymal stem cell infusion, compared to a placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The study is randomized, placebo-controlled, and double-blind, involving a single-dose intravenous infusion. Participants will be assigned to one of three groups: placebo, low-dose, or high-dose UMC119-06-05. The aim is to assess the long-term safety and potential benefits of this novel therapy in improving lung function and overall health outcomes for COPD patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 with a diagnosis of moderate to severe COPD and specific lung function criteria.

Not a fit: Patients with mild COPD or those whose condition is not stable may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option that may improve lung function and quality of life for patients with COPD.

How similar studies have performed: While the use of mesenchymal stem cells in treating COPD is innovative, similar approaches in other studies have shown promise, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

New Taipei City and 1 other locations

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

Study contacts

• Study coordinator: Ray Chang, Ph.D.

Conditions Chronic Obstructive Pulmonary Disease