Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-28 @ 10:19 PM
Study NCT ID:
NCT05594303
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COPD Treatment by Transplantation of Autologous Bronchial Basal Cells
Sponsor:
Guangzhou Institute of Respiratory Disease
Organization:
Study Overview
Official Title:
Research on Chronic Obstructive Pulmonary Disease (COPD) Treatment by Transplantation of Autologous Bronchial Basal Cells
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: