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

NCT03153800 | Unknown Early Phase 1

• 1 other identifier: 2017042
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Respiratory Disease

Outcome Measures

Primary Outcomes (2)

• Forced expiratory volume in one second (FEV1)

  One of the indicators in pulmonary function test, a marker to assess airway obstruction

  1-6 months

• Diffusion capacity of CO (DLCO)

  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

Secondary Outcomes (8)

• The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)

  1-6 months

• Maximum mid-expiratory flow (MMF)

  1-6 months

• Maximum voluntary ventilation (MVV)

  1-6 months

• Forced vital capacity (FVC)

  1-6 months

• 6-minute-walk test (6MWT)

  1-6 months

Study Arms (1)

Bronchial basal cells

EXPERIMENTAL

Biological: bronchial basal cells

Interventions

bronchial basal cells BIOLOGICAL

Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.

Bronchial basal cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regend Therapeutics: lead
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

The First Affiliated Hopsital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Related Links

• Related Info

Central Study Contacts

Wei Zuo, Ph. D.

CONTACT

086-400-882-1090; zuow@regend.cn

Jianan Huang, M. D.

CONTACT

huang_jian_an@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 15, 2017
• Study Start: April 5, 2017
• Primary Completion: April 4, 2021
• Study Completion: October 4, 2021
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)