Chronic Obstructive Pulmonary DiseasePhase 2NCT06491043
Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
A Phase 2 study testing UMC119-06-05 in people with Chronic Obstructive Pulmonary Disease, run by Meribank Biotech Co., Ltd. at 2 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- UMC119-06-05
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesTaiwan
- Study dates
- 11 Jun 2024to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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).
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- 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 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.
Who cannot join
- 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.
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- 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 screening.
- 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 prior to screening.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, 23561
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
About this study
Official title: 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 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.
Read the detailed description
Patients with chronic obstructive pulmonary disease (COPD) are characterized with airflow limitation and chronic inflammation, which is caused by cigarette smoking, noxious particles or gases. These inhaled irritants will induce inflammation, emphysema and fibrosis though chronic exposure. The current pharmacological treatment of COPD is symptomatic and is mainly based on bronchodilators and corticosteroids. Although current clinical treatment strategies can improve and stabilize COPD states and quality of life, none of them are able to modify the progressive decline in lung function, meaning it gradually gets worse over time. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of COPD in adult patients is of urgent need. Among the more innovative, experimental therapies, mesenchymal stromal cells are proposed as a novel therapy with potential in treatment of COPD. This clinical trial is a phase II study. It is a randomized, placebo-controlled, double-blind study. Eligible subjects will be randomized to one of the three groups: placebo control, low-dose UMC119-06-05 treatment, or high-dose UMC119-06-05 treatment. Subjects will receive a single-dose IV infusion to evaluate the efficacy and long-term safety of UMC119-06-05 with moderate to severe COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- UMC119-06-05
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMC119-06-05Other
Human Umbilical Cord Derived-Mesenchymal Stem Cells
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | normal saline, 4% human serum albumin Receives: Other: UMC119-06-05 |
| low-dose UMC119-06-05 treatment | Experimental | normal saline, 4% human serum albumin, 1×10^8 cells/subject Receives: Other: UMC119-06-05 |
| high-dose UMC119-06-05 treatment | Experimental | normal saline, 4% human serum albumin, 2×10^8 cells/subject Receives: Other: UMC119-06-05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
2.Incidence of related TEAEs and serious adverse events (SAEs) 3.Incidence of withdrawals due to adverse events (AEs) 4.Change/shift from baseline in laboratory tests 5.Change from baseline in vital signs 6.Shift from baseline in ECG results 7.Shift from baseline in physical examination results
Measured: From Baseline to Day 90]
Incidence of related TEAEs and serious adverse events (SAEs)
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
2.Incidence of related TEAEs and serious adverse events (SAEs) 3.Incidence of withdrawals due to adverse events (AEs) 4.Change/shift from baseline in laboratory tests 5.Change from baseline in vital signs 6.Shift from baseline in ECG results 7.Shift from baseline in physical examination results
Measured: through the study
Incidence of withdrawals due to adverse events (AEs)
AE incidence
Measured: through the study
Change/shift from baseline in laboratory tests
laboratory tests
Measured: Baseline, 2 hours (h), Days 3, 7, 14, 28, 90
Change from baseline in vital signs
measure vital signs
Measured: Baseline, 0 minute, 2 h, Days 3, 7, 14, 28, 90
shift from baseline in ECG results
ECG check
Measured: Baseline, 2 h, Day 14
Shift from baseline in physical examination results
physical examination
Measured: Baseline, 2 h, Days 3, 7, and 14
Secondary outcomes (10)
Mean change from baseline in forced vital capacity (FVC)
Respiratory functions (FVC) 2.Mean change from baseline in forced expiratory volume in one second (FEV1) 3.Mean change from baseline in FEV1/FVC ratio 4.Mean change from baseline in 6-minute walk test (6-MWT) 5.Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) score 6.Shift from baseline in modified Medical Research Council (mMRC) dyspnea scale 7.Incidence, frequency, and severity of COPD exacerbations 8.Time to first COPD exacerbation 9.Mean change or shift from baseline in Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index 10.The number of times that rescue medication is used
Measured: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in forced expiratory volume in one second (FEV1)
Respiratory functions (FEV1)
Measured: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in FEV1/FVC ratio
Respiratory functions (FEV1/FVC)
Measured: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in 6-minute walk test
measure 6 minute walk distance
Measured: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) score
Georges Respiratory Questionnaire has scores range from 0 to 100, with higher scores indicating more limitations
Measured: Baseline, Days 28, 90, 180, 270, 360
Shift from baseline in modified Medical Research Council (mMRC) dyspnea scale
mMRC dyspnea scale
Measured: Baseline, Days 28, 90, 180, 270, 360
Incidence, frequency, and severity of COPD exacerbations
assess severity of COPD
Measured: through the study
Time to first COPD exacerbation
assess severity and exacerbation
Measured: through the study
9. Mean change or shift from baseline in Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index
BODE index
Measured: baseline to Days 28, 90, 180, 270, 360
he number of times that rescue medication is used
times of rescue medication
Measured: through the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start11 Jun 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomized to one of the three groups: placebo control, low-dose allogeneic umbilical cord-derived mesenchymal stem cells UMC119-06-05 treatment, or high-dose UMC119-06-05 treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meribank Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491043
- Sponsor's protocol ID
- UMC119-06-05-COPD-02
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06491043
- Acronym / sponsor ID
- UMC119-06-05-COPD-02
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Meribank Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with chronic obstructive pulmonary disease (COPD) are characterized with airflow limitation and chronic inflammation, which is caused by cigarette smoking, noxious particles or gases. These inhaled irritants will induce inflammation, emphysema and fibrosis though chronic exposure. The current pharmacological treatment of COPD is symptomatic and is mainly based on bronchodilators and corticosteroids. Although current clinical treatment strategies can improve and stabilize COPD states and quality of life, none of them are able to modify the progressive decline in lung function, meaning it gradually gets worse over time. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of COPD in adult patients is of urgent need. Among the more innovative, experimental therapies, mesenchymal stromal cells are proposed as a novel therapy with potential in treatment of COPD. This clinical trial is a phase II study. It is a randomized, placebo-controlled, double-blind study. Eligible subjects will be randomized to one of the three groups: placebo control, low-dose UMC119-06-05 treatment, or high-dose UMC119-06-05 treatment. Subjects will receive a single-dose IV infusion to evaluate the efficacy and long-term safety of UMC119-06-05 with moderate to severe COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible subjects will be randomized to one of the three groups: placebo control, low-dose allogeneic umbilical cord-derived mesenchymal stem cells UMC119-06-05 treatment, or high-dose UMC119-06-05 treatment.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: UMC119-06-05normal saline, 4% human serum albumin |
| low-dose UMC119-06-05 treatment | Experimental | Other: UMC119-06-05normal saline, 4% human serum albumin, 1×10^8 cells/subject |
| high-dose UMC119-06-05 treatment | Experimental | Other: UMC119-06-05normal saline, 4% human serum albumin, 2×10^8 cells/subject |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UMC119-06-05Human Umbilical Cord Derived-Mesenchymal Stem Cells | Other | high-dose UMC119-06-05 treatment, low-dose UMC119-06-05 treatment, placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From Baseline to Day 90]
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. 2.Incidence of related TEAEs and serious adverse events (SAEs) 3.Incidence of withdrawals due to adverse events (AEs) 4.Change/shift from baseline in laboratory tests 5.Change from baseline in vital signs 6.Shift from baseline in ECG results 7.Shift from baseline in physical examination results
Incidence of related TEAEs and serious adverse events (SAEs)
Time frame: through the study
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. 2.Incidence of related TEAEs and serious adverse events (SAEs) 3.Incidence of withdrawals due to adverse events (AEs) 4.Change/shift from baseline in laboratory tests 5.Change from baseline in vital signs 6.Shift from baseline in ECG results 7.Shift from baseline in physical examination results
Incidence of withdrawals due to adverse events (AEs)
Time frame: through the study
AE incidence
Change/shift from baseline in laboratory tests
Time frame: Baseline, 2 hours (h), Days 3, 7, 14, 28, 90
laboratory tests
Change from baseline in vital signs
Time frame: Baseline, 0 minute, 2 h, Days 3, 7, 14, 28, 90
measure vital signs
shift from baseline in ECG results
Time frame: Baseline, 2 h, Day 14
ECG check
Shift from baseline in physical examination results
Time frame: Baseline, 2 h, Days 3, 7, and 14
physical examination
10 secondary outcomes
Mean change from baseline in forced vital capacity (FVC)
Time frame: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in forced expiratory volume in one second (FEV1)
Time frame: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in FEV1/FVC ratio
Time frame: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in 6-minute walk test
Time frame: Baseline, Days 28, 90, 180, 270, 360
Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) score
Time frame: Baseline, Days 28, 90, 180, 270, 360
Shift from baseline in modified Medical Research Council (mMRC) dyspnea scale
Time frame: Baseline, Days 28, 90, 180, 270, 360
Incidence, frequency, and severity of COPD exacerbations
Time frame: through the study
Time to first COPD exacerbation
Time frame: through the study
9. Mean change or shift from baseline in Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index
Time frame: baseline to Days 28, 90, 180, 270, 360
he number of times that rescue medication is used
Time frame: through the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UMC119-06-05 in people with Chronic Obstructive Pulmonary Disease, run by Meribank Biotech Co., Ltd. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ray Chang, Ph.D. (+886-2-8978-7777 ext. 19915, ray.chang@meribank.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: From Baseline to Day 90]). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.