Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

Primary Research on Treatment of Chronic Obstructive Pulmonary Disease (COPD) by Transplantation of Autologous Bronchial Basal Cells

Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Biological: bronchial basal cells

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Guang Dong
    • Shantou, Guang Dong, China, 515041
      • Recruiting
      • The First Affiliated Hospital of Shantou University Medical College
      • Contact: Xiaohe Zheng, M. D.; Phone Number: 086-0754-88258290; Email: 70229120@qq.com
      • Principal Investigator: Xiaohe Zheng, M. D.
      • Principal Investigator: Wei Zuo, Ph. D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 or 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: bronchial basal cells; Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.	Biological: bronchial basal cells; Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced expiratory volume in one second (FEV1)	An indicator for pulmonary function test to assess airway obstruction	1-6 months
Forced vital capacity (FVC)	An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation	1-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute-walk test (6MWT)	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	An indicator to evaluate the level of dyspnea	1-6 months
St. George's respiratory questionnaire (SGRQ) scale	A questionnaire to assess life quality affected by the respiratory problems	1-6 months
Diffusion capacity of CO (DLCO)	An indicator for pulmonary function test to show the extent to which oxygen passes from the air sacs of the lungs into the blood	1-6 months
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)	An indicator in pulmonary function test to represent 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)	An indicator in pulmonary function test to stand 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)	An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute	1-6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Shantou University Medical College
• Collaborators: Regend Therapeutics; Tongji University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: May 13, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2017112

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