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COPD Treatment by Transplantation of Autologous Bronchial Basal Cells

NCT05594303 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-09-21

No results posted yet for this study

Summary

Chronic obstructive pulmonary disease (COPD) is a group of disease characterized by obstructed airflow. Usually, the lung structure is gradually impaired along with the progression of the disease. Recently, the treatment of disease is challenged by shortage of approaches for regenerating the injured lung tissue. Here in this study, investigators intend to perform a single-centered, open, concurrent-controlled phase I/II clinical trial with autologous bronchial basal cells on COPD treatment since they were proved to regenerate lung tissue in animal models. The participants is recruited and divided into experiment group and control group. For patients from experiment group, bronchial basal cells will be isolated, expanded, carefully characterized in vitro and transplanted autologously into lung by fiberoptic bronchoscopy. No intervention is performed for patients from control group. During the study, the safety and efficacy will be evaluated on all the subjects by measuring the key indicators.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

BIOLOGICAL

Autologuos transplantation of bronchial basal cells

Autologuos transplantation of bronchial basal cells

Sponsors & Collaborators

  • Regend Therapeutics

    collaborator INDUSTRY

  • Guangzhou Institute of Respiratory Disease

    lead OTHER

Principal Investigators

  • Shiyue Li · Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

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
2019-11-27
Primary Completion
2022-05-16
Completion
2022-11-18

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 NCT05594303 on ClinicalTrials.gov