Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease Moderate
Status
Active
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
UMC119-06
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease Moderate focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Subjects of age between ≥ 40 through ≤ 75 years.
- Subjects with diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) standard.
- Subjects with a post-bronchodilator FEV1/FVC ratio <0.7.
- Subjects with a post-bronchodilator FEV1 % predicted value ≥ 50% and < 80%.
- Subjects with score ≥ 2 in the modified Medical Research Council Dyspnea Scale (mMRC).
- Subjects with in COPD Assessment Test (CAT) score ≥ 10.
- Subjects with body weight between 40 to 90 kg.
- Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.
Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, UNLESS they meet the following criteria:
- Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40 mIU/m, OR;
- 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy
- If a male and heterosexually active with a female of childbearing potential, the subject must agree to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study.
Exclusion Criteria:
- Subjects with history of any type of malignancy.
- Subjects with 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 previous 30 days.
- Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating.
- Subjects who have a significant concomitant illness as judged by principal investigator (PI).
- Subjects with known human immunodeficiency virus infection or who are immune compromised.
- Subjects with a known history of alcohol abuse or drug abuse within the 5 years before study treatment administration.
- Subjects who are current smokers.
- Subjects unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation.
- Subjects with a history of severe allergic or anaphylactic reactions.
- Subjects with known allergy or hypersensitivity to any component of the formulation or hypersensitivity to any component of the formulation (normal saline and human serum albumin).
- Subjects who have participated in another clinical study of new investigational therapies or have received an investigational therapy within the 12 weeks before study drug administration.
- Subjects with known Alpha-1 antitrypsin deficiency.
- Subjects with current active infection including pulmonary infection, systemic infection or severe local infections.
- Subjects with exacerbation of COPD within the 12 weeks before study treatment administration.
Subjects who have the following conditions in laboratory tests at screening;
- >2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or
- >2 × ULN for serum creatinine.
Sites / Locations
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UMC119-06
Arm Description
Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.
Outcomes
Primary Outcome Measures
The incidence and frequency of adverse events related to administration of UMC119-06.
Incidence of Treatment-Emergent Adverse Events (TEAEs).
Incidence of withdrawals due to Adverse Events(AEs).
Secondary Outcome Measures
Changes in Forced Vital Capacity (FVC).
Improvement in clinical function as assessed by mean change in Forced Vital Capacity (FVC).
Changes in Forced Expiratory Volume in One Second (FEV1).
Improvement in clinical function as assessed by mean change in Forced Expiratory Volume in One Second (FEV1).
Changes in the ratio of Forced Expiratory Volume in One Second to the Forced Vital Capacity (FEV1/FVC).
Improvement in clinical function as assessed by mean change in the ratio of Forced Expiratory Volume in One Second to the Forced Vital Capacity (FEV1/FVC).
Changes in exercise performance using 6-min walk test (6MWT).
Improvement in clinical function as assessed by mean change in exercise performance using 6-min walk test (6MWT).
Changes in Quality Of Life using St. George's Respiratory Questionnaire Safety (SGRQ).
Scores range from 0 (no impairment) to 100 (maximum impairment), with higher scores indicating more limitation. A decrease in score represents a decrease in disease related symptoms. Improvement in clinical function as assessed by mean change in Quality Of Life using St. George's Respiratory Questionnaire Safety (SGRQ).
Changes in modified medical research council (mMRC) -dyspnea scale.
Scores range from 0 (no dyspnea) to 4 (severe dyspnea), with higher scores indicate worse COPD control. Improvement in clinical function as assessed by mean change in modified medical research council (mMRC) -dyspnea scale.
Full Information
NCT ID
NCT04206007
First Posted
December 18, 2019
Last Updated
December 4, 2022
Sponsor
Meridigen Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04206007
Brief Title
Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease
Official Title
The Safety and Feasibility of UMC119-06 Cell Therapy in Subjects With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meridigen Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The clinical study with UMC119-06 is designed to investigate the safety in patients with Chronic Obstructive Pulmonary Disease. This will be a dose escalation, open label, single-center study in adult with chronic obstructive pulmonary disease. UMC119-06 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of chronic obstructive pulmonary disease.
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide, predicted to be the third leading cause of death in adults by 2020. Patients with 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, such as selective β2-adrenergic agonists (short-and long-acting), anticholinergics, theophylline, or a combination of these drugs. In patients with continuing exacerbations, inhaled corticosteroids (ICSs) may be added in the form of a triple fixed dose combination inhaler that includes ICSs, long-acting β2-agonists (LABA) and inhaled long-acting muscarinic antagonists (LAMA). 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 which is the hallmark of this disease. 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 (MSCs) are proposed as a novel therapy with potential in treatment of COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Moderate
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UMC119-06
Arm Type
Experimental
Arm Description
Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.
Intervention Type
Biological
Intervention Name(s)
UMC119-06
Intervention Description
Cohort 1: Low does of UMC119-06 Cohort 2: Medium does of UMC119- 06 Cohort 3: High does of UMC119-06
Primary Outcome Measure Information:
Title
The incidence and frequency of adverse events related to administration of UMC119-06.
Description
Incidence of Treatment-Emergent Adverse Events (TEAEs).
Incidence of withdrawals due to Adverse Events(AEs).
Time Frame
3 months from the day of administration
Secondary Outcome Measure Information:
Title
Changes in Forced Vital Capacity (FVC).
Description
Improvement in clinical function as assessed by mean change in Forced Vital Capacity (FVC).
Time Frame
15 months from the day of administration.
Title
Changes in Forced Expiratory Volume in One Second (FEV1).
Description
Improvement in clinical function as assessed by mean change in Forced Expiratory Volume in One Second (FEV1).
Time Frame
15 months from the day of administration.
Title
Changes in the ratio of Forced Expiratory Volume in One Second to the Forced Vital Capacity (FEV1/FVC).
Description
Improvement in clinical function as assessed by mean change in the ratio of Forced Expiratory Volume in One Second to the Forced Vital Capacity (FEV1/FVC).
Time Frame
15 months from the day of administration
Title
Changes in exercise performance using 6-min walk test (6MWT).
Description
Improvement in clinical function as assessed by mean change in exercise performance using 6-min walk test (6MWT).
Time Frame
15 months from the day of administration.
Title
Changes in Quality Of Life using St. George's Respiratory Questionnaire Safety (SGRQ).
Description
Scores range from 0 (no impairment) to 100 (maximum impairment), with higher scores indicating more limitation. A decrease in score represents a decrease in disease related symptoms. Improvement in clinical function as assessed by mean change in Quality Of Life using St. George's Respiratory Questionnaire Safety (SGRQ).
Time Frame
15 months from the day of administration.
Title
Changes in modified medical research council (mMRC) -dyspnea scale.
Description
Scores range from 0 (no dyspnea) to 4 (severe dyspnea), with higher scores indicate worse COPD control. Improvement in clinical function as assessed by mean change in modified medical research council (mMRC) -dyspnea scale.
Time Frame
15 months from the day of administration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of age between ≥ 40 through ≤ 75 years.
Subjects with diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) standard.
Subjects with a post-bronchodilator FEV1/FVC ratio <0.7.
Subjects with a post-bronchodilator FEV1 % predicted value ≥ 50% and < 80%.
Subjects with score ≥ 2 in the modified Medical Research Council Dyspnea Scale (mMRC).
Subjects with in COPD Assessment Test (CAT) score ≥ 10.
Subjects with body weight between 40 to 90 kg.
Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.
Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, UNLESS they meet the following criteria:
Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40 mIU/m, OR;
6 weeks post-surgical bilateral oophorectomy with or without hysterectomy
If a male and heterosexually active with a female of childbearing potential, the subject must agree to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study.
Exclusion Criteria:
Subjects with history of any type of malignancy.
Subjects with 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 previous 30 days.
Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating.
Subjects who have a significant concomitant illness as judged by principal investigator (PI).
Subjects with known human immunodeficiency virus infection or who are immune compromised.
Subjects with a known history of alcohol abuse or drug abuse within the 5 years before study treatment administration.
Subjects who are current smokers.
Subjects unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation.
Subjects with a history of severe allergic or anaphylactic reactions.
Subjects with known allergy or hypersensitivity to any component of the formulation or hypersensitivity to any component of the formulation (normal saline and human serum albumin).
Subjects who have participated in another clinical study of new investigational therapies or have received an investigational therapy within the 12 weeks before study drug administration.
Subjects with known Alpha-1 antitrypsin deficiency.
Subjects with current active infection including pulmonary infection, systemic infection or severe local infections.
Subjects with exacerbation of COPD within the 12 weeks before study treatment administration.
Subjects who have the following conditions in laboratory tests at screening;
>2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or
>2 × ULN for serum creatinine.
Facility Information:
Facility Name
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease
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