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NCT Number: NCT03188627

Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls 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, expanded 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Chongqing, Chongqing Municipality, 400038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.);
  • Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year;
  • 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.

Treatment and study plan

Bronchial basal cells

Biological

Transplantation of autologous bronchial basal cells

Primary outcomes

  1. Indicators for safety

    Time frame: 1-6 months

    Measured by blood routine test, urine routine test and blood chemistry panels

  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 outcomes

  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 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

  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.

  9. 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

Sponsors and collaborators

Lead sponsor

Regend Therapeutics

Industry

Collaborators

  • Southwest Hospital, China
  • Tongji University

Registry information

Official study title

A Single-centered, Non-randomized, Concurrent Control Study on Autologous Bronchial Basal Cell Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2017
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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