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Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF

Primary Purpose

Chronic Respiratory Disease

Status
Unknown status
Phase
Early 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 Respiratory Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with COPD, BE or PF according to the guideline;
  • Clinically stable for more than 4 weeks;
  • Tolerant to fiberoptic bronchoscopy test;
  • 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 investigators.

Sites / Locations

  • The First Affiliated Hopsital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bronchial basal cells

Arm Description

Outcomes

Primary Outcome Measures

Forced expiratory volume in one second (FEV1)
One of the indicators in pulmonary function test, a marker to assess airway obstruction
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 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
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.

Full Information

First Posted
May 10, 2017
Last Updated
September 16, 2019
Sponsor
Regend Therapeutics
Collaborators
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT03153800
Brief Title
Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF
Official Title
Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
April 4, 2021 (Anticipated)
Study Completion Date
October 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regend Therapeutics
Collaborators
The First Affiliated Hospital of Soochow 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 respiratory diseases including chronic obstructive pulmonary disease (COPD), bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli to repair the pulmonary injuries. In this study, we intend to perform an open, single-armed phase I clinical trial by transplantation of autologous bronchial basal cells on patients suffered from COPD, BE or PF. During the treatment, autologous bronchial basal cells, which were isolated from fiberoptic bronchoscopy and expanded in vitro, will be injected directly into lesions by fiberoptic bronchoscopy after careful characterization. In the following 6 months, 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 Respiratory 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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchial basal cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
bronchial basal cells
Intervention Description
Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.
Primary Outcome Measure Information:
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
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 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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with COPD, BE or PF according to the guideline; Clinically stable for more than 4 weeks; Tolerant to fiberoptic bronchoscopy test; 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 investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zuo, Ph. D.
Phone
086-400-882-1090
Email
zuow@regend.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jianan Huang, M. D.
Email
huang_jian_an@163.com
Facility Information:
Facility Name
The First Affiliated Hopsital of Soochow University
City
Suzhou
State/Province
Jiang Su
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianan Huang, M.D.
Email
huang_jian_an@163.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
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/25383540
Description
Related Info

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Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF

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