Actively Recruiting
Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
Led by Meribank Biotech Co., Ltd. · Updated on 2024-07-08
90
Participants Needed
2
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 40 and 80 years of age, any sex and race
- Diagnosed with COPD according to GOLD standards
- Post-bronchodilator FEV1/FVC ratio less than 0.70
- Post-bronchodilator FEV1 predicted value between 30% and less than 80%
- Score of 2 or higher on the mMRC dyspnea scale
- Score of 10 or higher on the COPD Assessment Test (CAT)
- Body weight between 40 and 90 kg
- Stable COPD with no treatment changes in the last 3 months
- Current or ex-smoker with at least 10 years or more of cigarette smoking history
- Women of child-bearing potential must have a negative pregnancy test at screening unless post-menopausal or surgically sterilized
- Agree to use double barrier birth control methods if heterosexually active and not surgically sterilized or post-menopausal
- Willing to provide written informed consent
You will not qualify if you...
- Active malignancy or history of active malignancy not in remission for at least 5 years
- Diagnosed with asthma or other clinically relevant lung diseases besides COPD
- Started pulmonary rehabilitation within 3 months prior to screening
- History of uncontrolled heart failure
- Pulmonary hypertension due to left heart condition
- Atrial fibrillation or significant congenital heart defect or disease
- Moderate or severe COPD exacerbation or mechanical ventilation within 30 days prior to screening
- Hospitalized at screening
- Current active infections including pulmonary, systemic, or severe local infections
- Abnormal laboratory values at screening including elevated liver enzymes, reduced kidney function, low blood counts, significant proteinuria or hematuria
- Stage 3 or higher chronic kidney disease
- Recent use of systemic steroids, immunosuppressants, chemotherapy, radiation, or cell therapies within 28 days or 5 half-lives
- Known alpha-1 antitrypsin deficiency
- Known allergy or severe hypersensitivity to study product components
- History of severe drug-related allergic reactions
- Major surgery within 30 days prior to screening
- Known HIV infection or immunocompromised status
- History of alcohol or drug abuse within 5 years prior
- Participation in another clinical trial or investigational therapy within 3 months prior
- Pregnant, planning pregnancy within 3 months after treatment, or lactating
- Life expectancy less than 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan, 23561
Actively Recruiting
2
Chang Gung Memorial Hospital, Linkou
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
R
Ray Chang, Ph.D.
CONTACT
J
Joseph Chen, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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