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

  • STATUS
    Recruiting
  • days left to enroll
    7
  • participants needed
    30
  • sponsor
    Regend Therapeutics
Updated on 23 January 2021

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.

Details
Condition Chronic Respiratory Disease
Treatment Bronchial basal cells
Clinical Study IdentifierNCT03153800
SponsorRegend Therapeutics
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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 -)
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
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