Back to resultsAutologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Bronchial basal cell
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Aged between 40 to 75;
- Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination.);
- Clinically stable for more than 4 weeks;
- Tolerant to bronchofiberscope;
- Written informed consent signed.
Exclusion Criteria:
- Pregnant or lactating women;
- Patients positive for syphilis, HIV;
- Patients with malignant tumor;
- Patients with serious significant pulmonary infection and need anti-infection treatment;
- Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
- Patients with a history of abusing alcohol and illicit drug;
- Patients participated in other clinical trials in the past 3 months;
- Patients assessed as inappropriate to participate in this clinical trial by investigator.
Sites / Locations
- Nanfang Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bronchial basal cells
Control
Arm Description
Outcomes
Primary Outcome Measures
Forced expiratory volume in one second (FEV1)
One of the indicators for pulmonary function
Forced vital capacity (FVC)
One of the indicators for pulmonary function
Secondary Outcome Measures
FEV1/FVC, MMF, MVV and DLCO
Other indicators for the pulmonary function
6 minute walk test (6MWT)
Indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
MMRC
Indicator to evaluate the level of dyspnea
SGRQ
A questionnaire to assess life quality affected by the respiratory problems
Full Information
NCT ID
NCT03092648
First Posted
March 22, 2017
Last Updated
March 22, 2017
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Regend Therapeutics, Tongji University
1. Study Identification
Unique Protocol Identification Number
NCT03092648
Brief Title
Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Regend Therapeutics, Tongji University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.
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 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
open, non-random, concurrent control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bronchial basal cells
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Bronchial basal cell
Intervention Description
autologous bronchial basal cell transplantation
Primary Outcome Measure Information:
Title
Forced expiratory volume in one second (FEV1)
Description
One of the indicators for pulmonary function
Time Frame
1-6 months
Title
Forced vital capacity (FVC)
Description
One of the indicators for pulmonary function
Time Frame
1-6 months
Secondary Outcome Measure Information:
Title
FEV1/FVC, MMF, MVV and DLCO
Description
Other indicators for the pulmonary function
Time Frame
1-6 months
Title
6 minute walk test (6MWT)
Description
Indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
Time Frame
1-6 months
Title
MMRC
Description
Indicator to evaluate the level of dyspnea
Time Frame
1-6 months
Title
SGRQ
Description
A questionnaire to assess life quality affected by the respiratory problems
Time Frame
1-6 months
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:
Aged between 40 to 75;
Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination.);
Clinically stable for more than 4 weeks;
Tolerant to bronchofiberscope;
Written informed consent signed.
Exclusion Criteria:
Pregnant or lactating women;
Patients positive for syphilis, HIV;
Patients with malignant tumor;
Patients with serious significant pulmonary infection and need anti-infection treatment;
Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
Patients with a history of abusing alcohol and illicit drug;
Patients participated in other clinical trials in the past 3 months;
Patients assessed as inappropriate to participate in this clinical trial by investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guodong Hu, M.D.
Email
huguodong123123@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zuo, Ph. D.
Email
zuow@regend.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zuo, Ph. D.
Organizational Affiliation
Regend Therapeutics Co.Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guodong Hu, M. D.
Email
huguodong123123@126.com
First Name & Middle Initial & Last Name & Degree
Wei Zuo, Ph. D.
Email
zuow@regend.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
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