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

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

Study Locations

    • Jiang Su
      • Suzhou, Jiang Su, China, 215006
        • Recruiting
        • The First Affiliated Hopsital of Soochow University
        • Contact:

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.

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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