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

Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)

Sponsors

Lead Sponsor: Regend Therapeutics

Collaborator: The First Affiliated Hospital of Soochow University

Source 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.

Overall Status Recruiting
Start Date April 5, 2017
Completion Date October 4, 2021
Primary Completion Date April 4, 2021
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Forced expiratory volume in one second (FEV1) 1-6 months
Diffusion capacity of CO (DLCO) 1-6 months
Secondary Outcome
Measure Time Frame
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
Modified medical research council (MMRC) chronic dyspnea scale 1-6 months
St. George's respiratory questionnaire (SGRQ) scale 1-6 months
Imaging of lung by high resolution computed tomography (HR-CT) 1-6 months
Enrollment 30
Condition
Intervention

Intervention Type: Biological

Intervention Name: bronchial basal cells

Description: Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.

Arm Group Label: Bronchial basal cells

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Contact

Last Name: Wei Zuo, Ph. D.

Phone: 086-400-882-1090

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: The First Affiliated Hopsital of Soochow University Jianan Huang, M.D. [email protected]
Location Countries

China

Verification Date

September 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Bronchial basal cells

Type: Experimental

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov