- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153800
Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF
September 16, 2019 updated by: Regend Therapeutics
Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wei Zuo, Ph. D.
- Phone Number: 086-400-882-1090
- Email: zuow@regend.cn
Study Contact Backup
- Name: Jianan Huang, M. D.
- Email: huang_jian_an@163.com
Study Locations
-
-
Jiang Su
-
Suzhou, Jiang Su, China, 215006
- Recruiting
- The First Affiliated Hopsital of Soochow University
-
Contact:
- Jianan Huang, M.D.
- Email: huang_jian_an@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bronchial basal cells
|
Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diffusion capacity of CO (DLCO)
Time Frame: 1-6 months
|
One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood
|
1-6 months
|
Forced expiratory volume in one second (FEV1)
Time Frame: 1-6 months
|
One of the indicators in pulmonary function test, a marker to assess airway obstruction
|
1-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
Time Frame: 1-6 months
|
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
|
1-6 months
|
Maximum mid-expiratory flow (MMF)
Time Frame: 1-6 months
|
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
|
1-6 months
|
Maximum voluntary ventilation (MVV)
Time Frame: 1-6 months
|
One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute
|
1-6 months
|
6-minute-walk test (6MWT)
Time Frame: 1-6 months
|
An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
|
1-6 months
|
Modified medical research council (MMRC) chronic dyspnea scale
Time Frame: 1-6 months
|
An indicator to evaluate the level of dyspnea
|
1-6 months
|
St. George's respiratory questionnaire (SGRQ) scale
Time Frame: 1-6 months
|
A questionnaire to assess life quality affected by the respiratory problems
|
1-6 months
|
Imaging of lung by high resolution computed tomography (HR-CT)
Time Frame: 1-6 months
|
HR-CT images of lung will be analyzed to indicate the pulmonary structure.
|
1-6 months
|
Forced vital capacity (FVC)
Time Frame: 1-6 months
|
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
|
1-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2017
Primary Completion (Anticipated)
April 4, 2021
Study Completion (Anticipated)
October 4, 2021
Study Registration Dates
First Submitted
May 10, 2017
First Submitted That Met QC Criteria
May 12, 2017
First Posted (Actual)
May 15, 2017
Study Record Updates
Last Update Posted (Actual)
September 18, 2019
Last Update Submitted That Met QC Criteria
September 16, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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