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Trial record 14 of 102 for:    Emphysema | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT03092648
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Collaborators:
Regend Therapeutics
Tongji University
Information provided by (Responsible Party):
Guodong HU, Nanfang Hospital of Southern Medical University

Brief Summary:
Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This study intends to carry out an open, single-armed, phase I/II clinical trial 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, cultured 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Biological: Bronchial basal cell Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open, non-random, concurrent control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Bronchial basal cells Biological: Bronchial basal cell
autologous bronchial basal cell transplantation

No Intervention: Control



Primary Outcome Measures :
  1. Forced expiratory volume in one second (FEV1) [ Time Frame: 1-6 months ]
    One of the indicators for pulmonary function

  2. Forced vital capacity (FVC) [ Time Frame: 1-6 months ]
    One of the indicators for pulmonary function


Secondary Outcome Measures :
  1. FEV1/FVC, MMF, MVV and DLCO [ Time Frame: 1-6 months ]
    Other indicators for the pulmonary function

  2. 6 minute walk test (6MWT) [ Time Frame: 1-6 months ]
    Indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases

  3. MMRC [ Time Frame: 1-6 months ]
    Indicator to evaluate the level of dyspnea

  4. SGRQ [ Time Frame: 1-6 months ]
    A questionnaire to assess life quality affected by the respiratory problems



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.);
  • Clinically stable for more than 4 weeks;
  • 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.

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): NCT03092648


Contacts
Contact: Guodong Hu, M.D. huguodong123123@126.com
Contact: Wei Zuo, Ph. D. zuow@regend.cn

Locations
China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Guodong Hu, M. D.       huguodong123123@126.com   
Contact: Wei Zuo, Ph. D.       zuow@regend.cn   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Regend Therapeutics
Tongji University
Investigators
Study Chair: Wei Zuo, Ph. D. Regend Therapeutics Co.Ltd

Responsible Party: Guodong HU, Chief Physician, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03092648     History of Changes
Other Study ID Numbers: NFEC-2016-187
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases