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New treatment option for Chronic Obstructive Pulmonary Disease
Official title Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
ClinicalTrials.gov ID: NCT06491043
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Between ≥40 and ≤80 years of age, of either sex and of any race.
- With diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standard.
- Has a post-bronchodilator FEV1/FVC ratio \<0.70.
- Has a post-bronchodilator FEV1 predicted value ≥30% and \<80%.
- With a score ≥2 in the mMRC dyspnea scale.
You likely can't join if
- 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...
- Diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g., restrictive lung diseases, sarcoidosis, tuberculosis...
- Has initiated pulmonary rehabilitation (e.g., exercise training) within 3 months prior to screening which, in the opinion of the Principal...
- Has documented history of uncontrolled heart failure.
- Has pulmonary hypertension due to left heart condition.
- Has atrial fibrillation or significant congenital heart defect/disease.
See the full eligibility criteria
Who can join
- Between ≥40 and ≤80 years of age, of either sex and of any race.
- With diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standard.
- Has a post-bronchodilator FEV1/FVC ratio \<0.70.
- Has a post-bronchodilator FEV1 predicted value ≥30% and \<80%.
- With a score ≥2 in the mMRC dyspnea scale.
- With a score ≥10 in the COPD Assessment Test (CAT).
- With a body weight ≥40 to ≤90 kg.
- 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.
- Is a current or ex-smoker, with a cigarette smoking history of ≥10 years or \>10 pack-years.
- 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...
What rules you out
- 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.
- 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).
- 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.
- Has documented history of uncontrolled heart failure.
- Has pulmonary hypertension due to left heart condition.
- Has atrial fibrillation or significant congenital heart defect/disease.
- 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.
- Is hospitalized at screening.
- With current active infection including pulmonary infection, systemic infection, or severe local infections.
- Have the following conditions in laboratory tests at screening:
- \>2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or
- Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2; or
- White blood cells (WBC) \<3.6 × 103/μL; or
- Platelet counts \<150 × 103/μL; or
- Hemoglobin \<10 g/dL; or
- Spot urine albumin-creatinine ratio (UACR) ≥30 mg/g; or
- Clinically significant hematuria or proteinuria deemed by the study investigator.
- With known stage ≥3 chronic kidney disease.
- 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...
- With known alpha-1 antitrypsin deficiency.
- With known allergy or hypersensitivity to any component of the investigational product (IP) formulation (normal saline and human serum albumin [HSA]).
- 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.
- 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...
- With known human immunodeficiency virus infection or immunocompromised.
- With a known history of alcohol abuse or drug abuse within 5 years prior to screening.
- Participating in another clinical study of new investigational therapies or have received an investigational therapy within 3 months prior to screening.
- Pregnant (or plan to become pregnant within 3 months after study treatment) or lactating.
- Has a life expectancy of \<6 months.
The study team makes the final eligibility decision.
Where it's taking place
- New Taipei City, Taiwan
- Taoyuan City, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Taipei City, Taiwan; Taoyuan City, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.