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

NCT03153800 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

bronchial basal cells

Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Regend Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2021-04-04
Completion
2021-10-04

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03153800 on ClinicalTrials.gov