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Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
bronchial basal cells
Sponsored by
First Affiliated Hospital of Shantou University Medical College
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 or 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

  • the First Affiliated Hospital of Shantou University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bronchial basal cells

Arm Description

Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.

Outcomes

Primary Outcome Measures

Forced expiratory volume in one second (FEV1)
An indicator for pulmonary function test to assess airway obstruction
Forced vital capacity (FVC)
An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation

Secondary Outcome Measures

Diffusion capacity of CO (DLCO)
An indicator for pulmonary function test to show the extent to which oxygen passes from the air sacs of the lungs into the blood
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
An indicator in pulmonary function test to represent the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity
Maximum mid-expiratory flow (MMF)
An indicator in pulmonary function test to stand for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second
Maximum voluntary ventilation (MVV)
An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute
6-minute-walk test (6MWT)
An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
Modified medical research council (MMRC) chronic dyspnea scale
An indicator to evaluate the level of dyspnea
St. George's respiratory questionnaire (SGRQ) scale
A questionnaire to assess life quality affected by the respiratory problems

Full Information

First Posted
May 13, 2017
Last Updated
May 16, 2017
Sponsor
First Affiliated Hospital of Shantou University Medical College
Collaborators
Regend Therapeutics, Tongji University
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1. Study Identification

Unique Protocol Identification Number
NCT03156673
Brief Title
Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells
Official Title
Primary Research on Treatment of Chronic Obstructive Pulmonary Disease (COPD) by Transplantation of Autologous Bronchial Basal Cells
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Shantou University Medical College
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
Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.

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
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bronchial basal cells
Arm Type
Experimental
Arm Description
Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.
Intervention Type
Biological
Intervention Name(s)
bronchial basal cells
Intervention Description
Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.
Primary Outcome Measure Information:
Title
Forced expiratory volume in one second (FEV1)
Description
An indicator for pulmonary function test to assess airway obstruction
Time Frame
1-6 months
Title
Forced vital capacity (FVC)
Description
An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation
Time Frame
1-6 months
Secondary Outcome Measure Information:
Title
Diffusion capacity of CO (DLCO)
Description
An indicator for pulmonary function test to show the extent to which oxygen passes from the air sacs of the lungs into the blood
Time Frame
1-6 months
Title
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
Description
An indicator in pulmonary function test to represent the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity
Time Frame
1-6 months
Title
Maximum mid-expiratory flow (MMF)
Description
An indicator in pulmonary function test to stand for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second
Time Frame
1-6 months
Title
Maximum voluntary ventilation (MVV)
Description
An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute
Time Frame
1-6 months
Title
6-minute-walk test (6MWT)
Description
An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
Time Frame
1-6 months
Title
Modified medical research council (MMRC) chronic dyspnea scale
Description
An indicator to evaluate the level of dyspnea
Time Frame
1-6 months
Title
St. George's respiratory questionnaire (SGRQ) scale
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 or 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
Xiaohe Zheng, M.D.
Phone
086-0754-88258290
Email
70229120@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zuo, Ph. D.
Email
zuow@regend.cn
Facility Information:
Facility Name
the First Affiliated Hospital of Shantou University Medical College
City
Shantou
State/Province
Guang Dong
ZIP/Postal Code
515041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohe Zheng, M. D.
Phone
086-0754-88258290
Email
70229120@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaohe Zheng, M. D.
First Name & Middle Initial & Last Name & Degree
Wei Zuo, Ph. D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

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