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Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Bronchial basal cells
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 - 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.);
  • Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year;
  • 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

  • First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bronchial basal cells

Control

Arm Description

Transplantation of autologous bronchial basal cells

Conventional treatment

Outcomes

Primary Outcome Measures

Indicators for safety
Measured by blood routine test, urine routine test and blood chemistry panels
Diffusion capacity of CO (DLCO)
One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood

Secondary Outcome Measures

The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
One of the indicators in pulmonary function test, representing 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)
One of the indicators in pulmonary function test, standing 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)
One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute
Forced expiratory volume in one second (FEV1)
One of the indicators in pulmonary function test, a marker to assess airway obstruction
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
Imaging of lung by high resolution computed tomography (HR-CT)
HR-CT images of lung will be analyzed to indicate the pulmonary structure.
Forced vital capacity (FVC)
One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation

Full Information

First Posted
June 13, 2017
Last Updated
March 23, 2023
Sponsor
Regend Therapeutics
Collaborators
Southwest Hospital, China, Tongji University
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1. Study Identification

Unique Protocol Identification Number
NCT03188627
Brief Title
Autologous Bronchial Basal Cell Transplantation for Treatment of COPD
Official Title
A Single-centered, Non-randomized, Concurrent Control Study on Autologous Bronchial Basal Cell Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
December 26, 2019 (Actual)
Study Completion Date
December 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regend Therapeutics
Collaborators
Southwest Hospital, China, Tongji University

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 usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls 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, expanded 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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronchial basal cells
Arm Type
Experimental
Arm Description
Transplantation of autologous bronchial basal cells
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional treatment
Intervention Type
Biological
Intervention Name(s)
Bronchial basal cells
Intervention Description
Transplantation of autologous bronchial basal cells
Primary Outcome Measure Information:
Title
Indicators for safety
Description
Measured by blood routine test, urine routine test and blood chemistry panels
Time Frame
1-6 months
Title
Diffusion capacity of CO (DLCO)
Description
One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood
Time Frame
1-6 months
Secondary Outcome Measure Information:
Title
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
Description
One of the indicators in pulmonary function test, representing 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
One of the indicators in pulmonary function test, standing 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
One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute
Time Frame
1-6 months
Title
Forced expiratory volume in one second (FEV1)
Description
One of the indicators in pulmonary function test, a marker to assess airway obstruction
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
Title
Imaging of lung by high resolution computed tomography (HR-CT)
Description
HR-CT images of lung will be analyzed to indicate the pulmonary structure.
Time Frame
1-6 months
Title
Forced vital capacity (FVC)
Description
One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation
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.); Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year; 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.
Facility Information:
Facility Name
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25383540
Citation
Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature13903. Epub 2014 Nov 12.
Results Reference
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Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

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