Clinical Trials List
Protocol NumberUMC119-06-05-COPD-02
Active
2024-04-01 - 2027-12-31
Phase II
Recruiting2
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 (COPD)
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Sponsor
Meribank
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
kang-Yun LEE
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Objectives
The primary objective of this study is to establish the safety and efficacy of UMC119-06-05 after a
single IV administration in subjects with moderate to severe COPD
Test Drug
injection
Active Ingredient
stem cells
Dosage Form
270
Dosage
1X10^8 cells/4 mL
Endpoints
Incidence of treatment-emergent adverse events (TEAEs) [Time Frame: From Baseline to Day
90]
2. Incidence of related TEAEs and serious adverse events (SAEs) [Time Frame: Throughout the
study]
3. Incidence of withdrawals due to adverse events (AEs) [Time Frame: Throughout the study]
4. Mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) score [Time
Frame: Baseline, Day 28, 90]
90]
2. Incidence of related TEAEs and serious adverse events (SAEs) [Time Frame: Throughout the
study]
3. Incidence of withdrawals due to adverse events (AEs) [Time Frame: Throughout the study]
4. Mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) score [Time
Frame: Baseline, Day 28, 90]
Inclution Criteria
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to participate in this study:
(1) Age ≥40 years and ≤80 years, regardless of sex or race
(2) Diagnosed with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines
(3) Forced expiratory vital capacity (FEV1) / Forced expiratory volume in one second (FEV1) ratio <0.70
(4) Predicted FEV1 value after bronchodilator use ≥30 and <80
(5) Revised Medical Research Council Dyspnea Scale (MRDS) score ≥2 or Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score ≥10
(6) Weight ≥40 to ≤90 kg
(7) Stable condition for the three months prior to screening, as determined by the study administrator, and without any adjustment to COPD standard treatment
(8) Current smoking habit or history of quitting smoking ≥10 years or >10 pack-years (pack-years)
(9) At screening, women of childbearing age should undergo a urine pregnancy test, and the result should be negative unless they meet the following criteria:
a. Have experienced spontaneous amenorrhea for 12 consecutive months, or have experienced spontaneous amenorrhea for 6 consecutive months with a serum follicle-stimulating hormone (FSH) level >40 mIU/mL; or
b. Have undergone bilateral oophorectomy at least 6 weeks ago, whether or not it included hysterectomy
(10) Subjects who are sexually active with the opposite sex must agree to use double barrier contraception (or have undergone surgical sterilization/have experienced amenorrhea),
and may not donate sperm/eggs during the study period
(11) Willing to sign a subject consent form to participate in this study
Participants must meet all of the following inclusion criteria to participate in this study:
(1) Age ≥40 years and ≤80 years, regardless of sex or race
(2) Diagnosed with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines
(3) Forced expiratory vital capacity (FEV1) / Forced expiratory volume in one second (FEV1) ratio <0.70
(4) Predicted FEV1 value after bronchodilator use ≥30 and <80
(5) Revised Medical Research Council Dyspnea Scale (MRDS) score ≥2 or Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score ≥10
(6) Weight ≥40 to ≤90 kg
(7) Stable condition for the three months prior to screening, as determined by the study administrator, and without any adjustment to COPD standard treatment
(8) Current smoking habit or history of quitting smoking ≥10 years or >10 pack-years (pack-years)
(9) At screening, women of childbearing age should undergo a urine pregnancy test, and the result should be negative unless they meet the following criteria:
a. Have experienced spontaneous amenorrhea for 12 consecutive months, or have experienced spontaneous amenorrhea for 6 consecutive months with a serum follicle-stimulating hormone (FSH) level >40 mIU/mL; or
b. Have undergone bilateral oophorectomy at least 6 weeks ago, whether or not it included hysterectomy
(10) Subjects who are sexually active with the opposite sex must agree to use double barrier contraception (or have undergone surgical sterilization/have experienced amenorrhea),
and may not donate sperm/eggs during the study period
(11) Willing to sign a subject consent form to participate in this study
Exclusion Criteria
Exclusion Criteria:
Subjects must not meet any of the following criteria to be included:
(1) Evidence of current malignancy, or a history of incomplete remission of malignancy within the five years prior to screening.
(2) Diagnosis of clinically relevant lung diseases other than asthma or chronic obstructive pulmonary disease (e.g., restrictive lung disease, sarcomatoid disease, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer).
(3) Commencement of pulmonary rehabilitation (e.g., exercise training) within three months prior to screening, which, according to the trial administrator, may affect the trial results.
(4) Recorded history of uncontrolled heart failure.
(5) Pulmonary hypertension due to left ventricular disease.
(6) Significant congenital heart defects/diseases.
(7) (8) Has experienced a moderate or severe exacerbation of chronic obstructive pulmonary disease (COPD) (according to GOLD criteria) or required mechanical ventilation (excluding continuous positive airway pressure [CPAP]) within 30 days prior to screening.
(9) Is currently hospitalized at the time of screening.
(10) Is currently infected with a known infection, including pulmonary infection, systemic infection, or severe local infection.
(11) Has any of the following laboratory test results at the time of screening:
a. Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 × Upper Limit of Normal (ULN); or
b. Glomerular filtration rate < 60 mL/min/1.73 m2; or
c. White blood cell count < 3.6 × 10³/μL; or
d. Platelet count < 150 × 103/μL; or e. Heme <10 g/dL; or f. Single urine albumin to creatinine ratio ≥30 mg/g; or g. Clinically significant hematuria or proteinuria as determined by the test administrator (11) Known to have stage III or higher chronic kidney disease (12) (13) Has received other immunosuppressants (excluding steroids, dose ≤10 mg/day), immunomodulators, cytotoxic agents, chemotherapy, radiation therapy, or other cell therapy within 28 days or 5 half-lives (whichever is longer) prior to screening.
(14) Has known α1-antitrypsin deficiency.
(15) Has known hypersensitivity or allergy to any component of the test product (physiological saline and human serum albumin).
Note: "Severe" is defined as CTCAE level 3 or higher.
(16) (17) Has undergone major surgery (surgery requiring anesthesia, such as tumor resection, open-chest surgery, cardiac surgery, abdominal surgery, intracranial surgery, or general surgery exceeding 3 hours) within 30 days prior to screening.
(18) Has a known history of human immunodeficiency virus infection or immune system deterioration.
(19) Is currently participating in another clinical trial of an experimental sexual therapy or has undergone an experimental sexual therapy within 3 months prior to screening.
(20) Pregnancy (or planned pregnancy during study treatment (or planned pregnancy within three months after study treatment) or during breastfeeding)
(21) Life expectancy <6 months
Subjects must not meet any of the following criteria to be included:
(1) Evidence of current malignancy, or a history of incomplete remission of malignancy within the five years prior to screening.
(2) Diagnosis of clinically relevant lung diseases other than asthma or chronic obstructive pulmonary disease (e.g., restrictive lung disease, sarcomatoid disease, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer).
(3) Commencement of pulmonary rehabilitation (e.g., exercise training) within three months prior to screening, which, according to the trial administrator, may affect the trial results.
(4) Recorded history of uncontrolled heart failure.
(5) Pulmonary hypertension due to left ventricular disease.
(6) Significant congenital heart defects/diseases.
(7) (8) Has experienced a moderate or severe exacerbation of chronic obstructive pulmonary disease (COPD) (according to GOLD criteria) or required mechanical ventilation (excluding continuous positive airway pressure [CPAP]) within 30 days prior to screening.
(9) Is currently hospitalized at the time of screening.
(10) Is currently infected with a known infection, including pulmonary infection, systemic infection, or severe local infection.
(11) Has any of the following laboratory test results at the time of screening:
a. Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 × Upper Limit of Normal (ULN); or
b. Glomerular filtration rate < 60 mL/min/1.73 m2; or
c. White blood cell count < 3.6 × 10³/μL; or
d. Platelet count < 150 × 103/μL; or e. Heme <10 g/dL; or f. Single urine albumin to creatinine ratio ≥30 mg/g; or g. Clinically significant hematuria or proteinuria as determined by the test administrator (11) Known to have stage III or higher chronic kidney disease (12) (13) Has received other immunosuppressants (excluding steroids, dose ≤10 mg/day), immunomodulators, cytotoxic agents, chemotherapy, radiation therapy, or other cell therapy within 28 days or 5 half-lives (whichever is longer) prior to screening.
(14) Has known α1-antitrypsin deficiency.
(15) Has known hypersensitivity or allergy to any component of the test product (physiological saline and human serum albumin).
Note: "Severe" is defined as CTCAE level 3 or higher.
(16) (17) Has undergone major surgery (surgery requiring anesthesia, such as tumor resection, open-chest surgery, cardiac surgery, abdominal surgery, intracranial surgery, or general surgery exceeding 3 hours) within 30 days prior to screening.
(18) Has a known history of human immunodeficiency virus infection or immune system deterioration.
(19) Is currently participating in another clinical trial of an experimental sexual therapy or has undergone an experimental sexual therapy within 3 months prior to screening.
(20) Pregnancy (or planned pregnancy during study treatment (or planned pregnancy within three months after study treatment) or during breastfeeding)
(21) Life expectancy <6 months
The Estimated Number of Participants
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Taiwan
114 participants
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Global
114 participants
