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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03153800
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
The First Affiliated Hospital of Soochow University
Information provided by (Responsible Party):
Regend Therapeutics

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.

Condition or disease Intervention/treatment Phase
Chronic Respiratory Disease Biological: bronchial basal cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : April 4, 2021
Estimated Study Completion Date : October 4, 2021

Arm Intervention/treatment
Experimental: Bronchial basal cells Biological: bronchial basal cells
Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Modified medical research council (MMRC) chronic dyspnea scale [ Time Frame: 1-6 months ]
    An indicator to evaluate the level of dyspnea

  7. St. George's respiratory questionnaire (SGRQ) scale [ Time Frame: 1-6 months ]
    A questionnaire to assess life quality affected by the respiratory problems

  8. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153800


Contacts
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Contact: Wei Zuo, Ph. D. 086-400-882-1090 zuow@regend.cn
Contact: Jianan Huang, M. D. huang_jian_an@163.com

Locations
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China, Jiang Su
The First Affiliated Hopsital of Soochow University Recruiting
Suzhou, Jiang Su, China, 215006
Contact: Jianan Huang, M.D.       huang_jian_an@163.com   
Contact: Wei Zuo, Ph. D.       zuow@regend.cn   
Sponsors and Collaborators
Regend Therapeutics
The First Affiliated Hospital of Soochow University

Additional Information:
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Responsible Party: Regend Therapeutics
ClinicalTrials.gov Identifier: NCT03153800    
Other Study ID Numbers: 2017042
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases