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Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
REGEND001 Autologous Therapy Product
Placebo
Sponsored by
Regend Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, aged 40 to 80 at the time of screening Diagnosed with COPD for at least 1 year according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD). At the time of screening, the diffusion function of carbon monoxide (DLCO-sb) is ≥ 20% and < 80% of the predicted value by single-breath method. At the time of screening, the subject has received standardized treatment with GOLD recommended drugs and was in stable condition for ≥ 4 weeks Tolerated for pulmonary function tests Tolerated for bronchoscopy Voluntary to sign the informed consent, and be compliant to complete the procedures and inspections all through the trial. Exclusion Criteria: Female subjects who are pregnant, nursing, or planning to be pregnant after using this product (or male subjects planning to have a pregnant spouse); and participants who did not agree to use a reliable method of contraception within one year from signing informed consent At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test. Hepatitis B virus carriers (only HBsAg positive, no hepatitis symptoms and signs, all liver function tests are normal) with stable current condition (deoxyribonucleic acid (DNA) titer is not higher than 500 IU/mL or copy number is less than 1000 copies/mL) can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well. Subject who is assessed to have < 1 year survival time by investigators. Subject with malignant tumors at present or prior to screening. Subject with infections in lung or other sites, requiring intravenous drug treatment within 1 week before screening. Infections are caused by bacteria, virus or others. Subject with two or more exacerbations of moderate to severe COPD and hospitalized by exacerbations within 1 year before screening and led to hospitalization Subject with a history of invasive or noninvasive mechanical ventilation within 4 weeks before screening Subject who has taken prednisone tablets orally and dose ≥ 20 mg/day (or equivalent amount of other oral corticosteroids) within 4 weeks before screening Subject who is assessed to have major lung diseases other than COPD (such as connective tissue disease-related interstitial lung disease, pneumoconiosis, active tuberculosis, primary bronchiectasis, lung cancer, bronchial asthma, severe pulmonary hypertension [>70 mmHg]) by investigators at screening. Subject who has other severe systemic diseases within 6 months before screening or currently, such as diabetes mellitus (glycosylated hemoglobin≥7%), myocardial infarction, unstable angina, congestive heart failure (New York Heart Association [NYHA] class III/IV), stroke, cirrhosis with abnormal liver function (alanine aminotransferase test [ALT], aspartate aminotransferase test [AST] 2.5 times above the upper limit, total bilirubin 1.5 times more than the upper limit of normal), Acute and chronic renal insufficiency (blood creatinine 1.5 times exceeds the upper limit of the normal value), hyperthyroidism, polycythemia vera, etc Subject with deficiency of agranulocytosis (leukocyte < 1.5×10^9/L or neutrophils <0.5×10^9/L), thrombocytopenia (platelet < 100×10^9/L) or severe anemia (hemoglobin<30g/L) at screening. Subject with coagulopathy during the screening period. Subject who has taken anticoagulant therapy and antiplatelet agglutination therapy, such as warfarin, heparin, aspirin, or Plavix within 1 week prior to screening. Subject at risk of suicide or has a history of mental illness or epilepsy at the time of screening. Subject who has severe arrhythmias (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II and above heart conduct abnormalities in 12-lead ECG test at screening. Subject who has a history of alcohol abuse (drinking more than 14 units of alcohol per week [1 unit of alcohol = 360 mL of beer or 45 mL of spirits or 150 mL of wine] within 1 year prior to screening) or illicit drug abuse Subject allergic to cattle products Subject participated in other clinical trials within 3 months prior to screening Investigators, co-investigators, research coordinators, employees of research participants or research centers, or their family members. Any circumstances that the investigator believes may increase the risk to the patient or interfere with the clinical trial.

Sites / Locations

  • China-Japan Friendship HospitalRecruiting
  • The Southwest Hospital of AMURecruiting
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
  • Shanghai East HospitalRecruiting
  • Zhongshan Hospital affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

REGEND001 Autologous Therapy Product

Placebo

Arm Description

Transplantation of REGEND001 Autologous Therapy Product

Transplantation of Placebo

Outcomes

Primary Outcome Measures

Complete response (CR) rate of diffusing capacity of the lung for carbon monoxide (DLCO)
Complete response is defined as a ≥10% increase in lung carbon oxide diffusion function (DLCO-sb) from baseline. DLCO-sb is measured by the single-breath method.

Secondary Outcome Measures

Change of lung diffusing capacity for single-breath carbon monoxide (DLCO-sb) from baseline
DLCO-sb is measured by the single-breath method. It is considered a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
Change of arterial oxygen partial pressure (PaO2) from baseline
PaO2 is a measurement of oxygen pressure in arterial blood. Change of PaO2 reflects increase or decrease of oxygen exchange from lungs to blood.
Change of blood oxygen saturation (SpO2) from baseline
SpO2 relative to baseline is a measure of how much oxygen is in the blood. Change of SpO2 reflects increase or decrease of oxygen exchange from lungs to blood.
Change of images of lung by high resolution computed tomography (HR-CT) from baseline
HR-CT images of lung will be analyzed to indicate the change of pulmonary structure.
Forced vital capacity(FVC)
FVC is the full amount of air that can be exhaled with effort in a complete breath.
Forced expiratory volume in one second (FEV1)
FEV1 is the volume of breath exhaled with effort in one second.
The ratio of Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)
The FEV1/FVC is a ratio that reflects the amount of air you can forcefully exhale from your lungs. It's measured by spirometry, a test used to evaluate lung function.
The ratio of the diffusing capacity for carbon monoxide/ the alveolar volume (DLCO/VA)
The DLCO test refers to the diffusing capacity for carbon monoxide in the lungs. It's a type of pulmonary function test that helps to assess how well gas is exchanged between the lungs and the bloodstream.Since DLCO is affected by the amount of inhaled gas and lung volume, the subject's alveolar ventilation (VA) should be considered when evaluating diffusion function to exclude the effect of lung volume on diffusion volume.
Change of 6-minute-walk test (6MWT) from baseline
The 6MWT is a commonly used test for the objective assessment of functional exercise capacity by testing the distance patients can walk at the fastest speed within 6 minutes.
Change of St. George's respiratory questionnaire (SGRQ) scale from baseline
Quality of life was assessed by St. George's respiratory questionnaire (SGRQ) scale. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.
Change of modified medical research council (mMRC) chronic dyspnea scale from baseline
It is a questionnaire in which patient has to understand the activity when he feels dyspnoea and based on that patient has to grade the dyspnoea, mMRC results are divided into 0-4 grades according to the degree of activity of the patient when the patient has shortness of breath, and grade 4 indicates that the patient has difficulty breathing at the slightest activity.
Change of chronic obstructive pulmonary disease Assessment Test(CAT)from baseline
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT scale includes a total of 8 items, 0~5 points for each item. The total score ranges 0~40 points. Score of 0-10 points indicates slight impact; Score of 11-20 points indicates medium impact: Score of 21-30 points indicates serious impact; Score of 31-40 points indicates very serious impact.
Time to first COPD exacerbation
Exacerbations, are a worsening of COPD symptoms, and frequent exacerbations indicate a deterioration and progression of the disease. A longer time to exacerbations means improvement of disease.
Annual frequency of exacerbations
Frequency of exacerbations all through the year. A lower frequency means improvement of disease.
Temperature
Number of cases with abnormal physical examination findings.
Breathing
Number of cases with abnormal physical examination findings.
Pulse
Number of cases with abnormal physical examination findings.
Blood pressure
Number of cases with abnormal physical examination findings.
Symptoms, physical examination
Number of cases with abnormal physical examination findings.
12-lead ECG
Number of cases with abnormal 12-lead Electrocardiogram (ECG).
Blood routine
Number of cases with abnormal laboratory test results.
Urine routine
Number of cases of participants with abnormal laboratory test results.
Blood biochemistry
Number of cases of participants with abnormal laboratory test results.
Function of blood clotting
Number of cases of participants with abnormal function of blood clotting.
Myocardial enzyme profile
Myocardial enzyme profile is tested for safety assessment.
Antibody testing for autoimmune diseases
Antibodies related to autoimmune diseases are tested for safety assessment.
Carcinoembryonic antigen (CEA)
CEA is a tumor marker used for early diagnosis of lung cancer.
Neuron-specific enolase (NSE)
NSE is a tumor marker significantly elevated in small cell lung cancer.
Cytokeratin-19-fragment (CYFRA21-1)
CYFRA21-1 is a tumor marker which has important value for the pathological classification and prognosis evaluation of lung cancer.
Squamous cell carcinoma antigen (SCC)
SCC is a specific marker for lung squamous cell carcinoma.Tumor markers are monitored to assess the safety.

Full Information

First Posted
November 2, 2022
Last Updated
October 10, 2023
Sponsor
Regend Therapeutics
Collaborators
The First Affiliated Hospital of Guangzhou Medical University, Ruijin Hospital, Southwest Hospital, China, Shanghai Zhongshan Hospital, China-Japan Friendship Hospital, Shanghai East Hospital, Regend Therapeutics XLotus (Jiangxi) Co, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05638776
Brief Title
Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy
Official Title
A Multicenter, Randomized, Single-Blind, Placebo-Parallel-Controlled Research of REGEND001 Cell Therapy for Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regend Therapeutics
Collaborators
The First Affiliated Hospital of Guangzhou Medical University, Ruijin Hospital, Southwest Hospital, China, Shanghai Zhongshan Hospital, China-Japan Friendship Hospital, Shanghai East Hospital, Regend Therapeutics XLotus (Jiangxi) Co, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND001 Autologous Therapy Product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, single-blind, placebo-parallel-controlled trial is performed to assess the efficacy and safety of REGEND001 Autologous Therapy Product in treatment of chronic obstructive pulmonary disease with pulmonary diffusion dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REGEND001 Autologous Therapy Product
Arm Type
Experimental
Arm Description
Transplantation of REGEND001 Autologous Therapy Product
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Transplantation of Placebo
Intervention Type
Drug
Intervention Name(s)
REGEND001 Autologous Therapy Product
Intervention Description
Transplantation of Autologous Therapy Product by
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Transplantation of Placebo
Primary Outcome Measure Information:
Title
Complete response (CR) rate of diffusing capacity of the lung for carbon monoxide (DLCO)
Description
Complete response is defined as a ≥10% increase in lung carbon oxide diffusion function (DLCO-sb) from baseline. DLCO-sb is measured by the single-breath method.
Time Frame
12 weeks after treatment
Secondary Outcome Measure Information:
Title
Change of lung diffusing capacity for single-breath carbon monoxide (DLCO-sb) from baseline
Description
DLCO-sb is measured by the single-breath method. It is considered a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Change of arterial oxygen partial pressure (PaO2) from baseline
Description
PaO2 is a measurement of oxygen pressure in arterial blood. Change of PaO2 reflects increase or decrease of oxygen exchange from lungs to blood.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Change of blood oxygen saturation (SpO2) from baseline
Description
SpO2 relative to baseline is a measure of how much oxygen is in the blood. Change of SpO2 reflects increase or decrease of oxygen exchange from lungs to blood.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Change of images of lung by high resolution computed tomography (HR-CT) from baseline
Description
HR-CT images of lung will be analyzed to indicate the change of pulmonary structure.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Forced vital capacity(FVC)
Description
FVC is the full amount of air that can be exhaled with effort in a complete breath.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Forced expiratory volume in one second (FEV1)
Description
FEV1 is the volume of breath exhaled with effort in one second.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
The ratio of Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)
Description
The FEV1/FVC is a ratio that reflects the amount of air you can forcefully exhale from your lungs. It's measured by spirometry, a test used to evaluate lung function.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
The ratio of the diffusing capacity for carbon monoxide/ the alveolar volume (DLCO/VA)
Description
The DLCO test refers to the diffusing capacity for carbon monoxide in the lungs. It's a type of pulmonary function test that helps to assess how well gas is exchanged between the lungs and the bloodstream.Since DLCO is affected by the amount of inhaled gas and lung volume, the subject's alveolar ventilation (VA) should be considered when evaluating diffusion function to exclude the effect of lung volume on diffusion volume.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Change of 6-minute-walk test (6MWT) from baseline
Description
The 6MWT is a commonly used test for the objective assessment of functional exercise capacity by testing the distance patients can walk at the fastest speed within 6 minutes.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Change of St. George's respiratory questionnaire (SGRQ) scale from baseline
Description
Quality of life was assessed by St. George's respiratory questionnaire (SGRQ) scale. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Change of modified medical research council (mMRC) chronic dyspnea scale from baseline
Description
It is a questionnaire in which patient has to understand the activity when he feels dyspnoea and based on that patient has to grade the dyspnoea, mMRC results are divided into 0-4 grades according to the degree of activity of the patient when the patient has shortness of breath, and grade 4 indicates that the patient has difficulty breathing at the slightest activity.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Change of chronic obstructive pulmonary disease Assessment Test(CAT)from baseline
Description
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT scale includes a total of 8 items, 0~5 points for each item. The total score ranges 0~40 points. Score of 0-10 points indicates slight impact; Score of 11-20 points indicates medium impact: Score of 21-30 points indicates serious impact; Score of 31-40 points indicates very serious impact.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Time to first COPD exacerbation
Description
Exacerbations, are a worsening of COPD symptoms, and frequent exacerbations indicate a deterioration and progression of the disease. A longer time to exacerbations means improvement of disease.
Time Frame
48 weeks after treatment
Title
Annual frequency of exacerbations
Description
Frequency of exacerbations all through the year. A lower frequency means improvement of disease.
Time Frame
1 year after treatment
Title
Temperature
Description
Number of cases with abnormal physical examination findings.
Time Frame
Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Breathing
Description
Number of cases with abnormal physical examination findings.
Time Frame
Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Pulse
Description
Number of cases with abnormal physical examination findings.
Time Frame
Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Blood pressure
Description
Number of cases with abnormal physical examination findings.
Time Frame
Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Symptoms, physical examination
Description
Number of cases with abnormal physical examination findings.
Time Frame
Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
12-lead ECG
Description
Number of cases with abnormal 12-lead Electrocardiogram (ECG).
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Blood routine
Description
Number of cases with abnormal laboratory test results.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Urine routine
Description
Number of cases of participants with abnormal laboratory test results.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Blood biochemistry
Description
Number of cases of participants with abnormal laboratory test results.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Function of blood clotting
Description
Number of cases of participants with abnormal function of blood clotting.
Time Frame
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Myocardial enzyme profile
Description
Myocardial enzyme profile is tested for safety assessment.
Time Frame
Baseline, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Antibody testing for autoimmune diseases
Description
Antibodies related to autoimmune diseases are tested for safety assessment.
Time Frame
Baseline, 12 weeks after treatment, 48 weeks after treatment
Title
Carcinoembryonic antigen (CEA)
Description
CEA is a tumor marker used for early diagnosis of lung cancer.
Time Frame
Baseline, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Neuron-specific enolase (NSE)
Description
NSE is a tumor marker significantly elevated in small cell lung cancer.
Time Frame
Baseline, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Cytokeratin-19-fragment (CYFRA21-1)
Description
CYFRA21-1 is a tumor marker which has important value for the pathological classification and prognosis evaluation of lung cancer.
Time Frame
Baseline, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment
Title
Squamous cell carcinoma antigen (SCC)
Description
SCC is a specific marker for lung squamous cell carcinoma.Tumor markers are monitored to assess the safety.
Time Frame
Baseline, 12 weeks after treatment, 24 weeks after treatment, 48 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged 40 to 80 at the time of screening Diagnosed with COPD for at least 1 year according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD). At the time of screening, the diffusion function of carbon monoxide (DLCO-sb) is ≥ 20% and < 80% of the predicted value by single-breath method. At the time of screening, the subject has received standardized treatment with GOLD recommended drugs and was in stable condition for ≥ 4 weeks Tolerated for pulmonary function tests Tolerated for bronchoscopy Voluntary to sign the informed consent, and be compliant to complete the procedures and inspections all through the trial. Exclusion Criteria: Female subjects who are pregnant, nursing, or planning to be pregnant after using this product (or male subjects planning to have a pregnant spouse); and participants who did not agree to use a reliable method of contraception within one year from signing informed consent At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test. Hepatitis B virus carriers (only HBsAg positive, no hepatitis symptoms and signs, all liver function tests are normal) with stable current condition (deoxyribonucleic acid (DNA) titer is not higher than 500 IU/mL or copy number is less than 1000 copies/mL) can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well. Subject who is assessed to have < 1 year survival time by investigators. Subject with malignant tumors at present or prior to screening. Subject with infections in lung or other sites, requiring intravenous drug treatment within 1 week before screening. Infections are caused by bacteria, virus or others. Subject with two or more exacerbations of moderate to severe COPD and hospitalized by exacerbations within 1 year before screening and led to hospitalization Subject with a history of invasive or noninvasive mechanical ventilation within 4 weeks before screening Subject who has taken prednisone tablets orally and dose ≥ 20 mg/day (or equivalent amount of other oral corticosteroids) within 4 weeks before screening Subject who is assessed to have major lung diseases other than COPD (such as connective tissue disease-related interstitial lung disease, pneumoconiosis, active tuberculosis, primary bronchiectasis, lung cancer, bronchial asthma, severe pulmonary hypertension [>70 mmHg]) by investigators at screening. Subject who has other severe systemic diseases within 6 months before screening or currently, such as diabetes mellitus (glycosylated hemoglobin≥7%), myocardial infarction, unstable angina, congestive heart failure (New York Heart Association [NYHA] class III/IV), stroke, cirrhosis with abnormal liver function (alanine aminotransferase test [ALT], aspartate aminotransferase test [AST] 2.5 times above the upper limit, total bilirubin 1.5 times more than the upper limit of normal), Acute and chronic renal insufficiency (blood creatinine 1.5 times exceeds the upper limit of the normal value), hyperthyroidism, polycythemia vera, etc Subject with deficiency of agranulocytosis (leukocyte < 1.5×10^9/L or neutrophils <0.5×10^9/L), thrombocytopenia (platelet < 100×10^9/L) or severe anemia (hemoglobin<30g/L) at screening. Subject with coagulopathy during the screening period. Subject who has taken anticoagulant therapy and antiplatelet agglutination therapy, such as warfarin, heparin, aspirin, or Plavix within 1 week prior to screening. Subject at risk of suicide or has a history of mental illness or epilepsy at the time of screening. Subject who has severe arrhythmias (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II and above heart conduct abnormalities in 12-lead ECG test at screening. Subject who has a history of alcohol abuse (drinking more than 14 units of alcohol per week [1 unit of alcohol = 360 mL of beer or 45 mL of spirits or 150 mL of wine] within 1 year prior to screening) or illicit drug abuse Subject allergic to cattle products Subject participated in other clinical trials within 3 months prior to screening Investigators, co-investigators, research coordinators, employees of research participants or research centers, or their family members. Any circumstances that the investigator believes may increase the risk to the patient or interfere with the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyue Li, Professor
Phone
+86-20-83062114
Email
lishiyue@188.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffery Ren
Phone
+86-16602112059
Email
renjie@regend.cn
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Yang
Facility Name
The Southwest Hospital of AMU
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangdong Zhou
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyue Li
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jieming Qu, M.D.
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Li
Facility Name
Zhongshan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanlin Song

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy

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