Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells

NCT06491043 | Recruiting Phase 2 DMC

• 1 other identifier: UMC119-06-05-COPD-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (7)

• 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

  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

  through the study

• Incidence of withdrawals due to adverse events (AEs)

  AE incidence

  through the study

• Change/shift from baseline in laboratory tests

  laboratory tests

  Baseline, 2 hours (h), Days 3, 7, 14, 28, 90

• Change from baseline in vital signs

  measure vital signs

  Baseline, 0 minute, 2 h, Days 3, 7, 14, 28, 90

• shift from baseline in ECG results

  ECG check

  Baseline, 2 h, Day 14

• Shift from baseline in physical examination results

  physical examination

  Baseline, 2 h, Days 3, 7, and 14

Secondary Outcomes (10)

• Mean change from baseline in forced vital capacity (FVC)

  Baseline, Days 28, 90, 180, 270, 360

• Mean change from baseline in forced expiratory volume in one second (FEV1)

  Baseline, Days 28, 90, 180, 270, 360

• Mean change from baseline in FEV1/FVC ratio

  Baseline, Days 28, 90, 180, 270, 360

• Mean change from baseline in 6-minute walk test

  Baseline, Days 28, 90, 180, 270, 360

• Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) score

  Baseline, Days 28, 90, 180, 270, 360

Study Arms (3)

placebo

PLACEBO COMPARATOR

normal saline, 4% human serum albumin

Other: UMC119-06-05

low-dose UMC119-06-05 treatment

EXPERIMENTAL

normal saline, 4% human serum albumin, 1×10\^8 cells/subject

Other: UMC119-06-05

high-dose UMC119-06-05 treatment

EXPERIMENTAL

normal saline, 4% human serum albumin, 2×10\^8 cells/subject

Other: UMC119-06-05

Interventions

UMC119-06-05 OTHER

Human Umbilical Cord Derived-Mesenchymal Stem Cells

high-dose UMC119-06-05 treatment; low-dose UMC119-06-05 treatment; placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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 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.
• Willing to provide written informed consent to participate in the study.

You may not qualify 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 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

Sponsors & Collaborators

• Meribank Biotech Co., Ltd.: lead

Study Sites (2)

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, 23561, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ray Chang, Ph.D.

CONTACT

+886-2-8978-7777; ray.chang@meribank.com.tw

Joseph Chen, Ph.D.

CONTACT

+886-2-8978-7777; joseph.chen@meribank.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 8, 2024
• Study Start: June 11, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)