Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

NCT03092648 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-28

No results posted yet for this study

Summary

Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Conditions

Interventions

BIOLOGICAL

Bronchial basal cell

autologous bronchial basal cell transplantation

Sponsors & Collaborators

  • Regend Therapeutics

    collaborator INDUSTRY
  • Tongji University

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Wei Zuo, Ph. D. · Regend Therapeutics Co.Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-12-30
Completion
2019-02-28

Countries

  • China

Study Locations

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Entities

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 NCT03092648 on ClinicalTrials.gov