Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03021681
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2017-01-12
Brief Title:
An Exploratory Study on the Treatment of Chronic Obstructive Pulmonary Disease With Autologous Bronchial Basal Cell Transplantation
Sponsor:
Huaian No1 Peoples Hospital
Organization:
Huaian No1 Peoples Hospital
Study Overview
Official Title:
Huaian First People s HospitalNanjing Medical University
Status:
COMPLETED
Status Verified Date:
2020-08
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 diseaseCOPDis characterized by recurrent cough expectoration and asthma and eventually develop chronic pulmonary heart disease chronic respiratory failure and even death The current clinical treatments for these patients are symptomatic treatment cannot solve the problem of the damaged lung structure fundamentally Recent studies show that bronchial basement the layer of cells is a kind of cells in the bronchial epithelial basal layer position the specific expression of Krt5 antigen with the regeneration and repair of lung function these cells have the activity similar to adult tissue stem cells Its division and migration are more active and can continue to produce new cells to complement the death of other types of epithelial cells with functional plasticity which can be used to direct repair the bronchial and alveolar structures It has been proved that bronchial basal cell transplantation can repair the damaged lungs of experimental animals The bronchial basal cells from autologous tissue so there is no immune rejection problem Also because the bronchial basal cells derived from adult tissues which is a part of the body so there is no risk of a tumor in animal experiments In animal experiments bronchial basal cells transtracheal input 100 times in human dose still no tumor formation In the early stage patients with COPD 2 cases bronchiectasis 2 cases and interstitial lung disease 1 case received the treatment and the overall effect was good Diseases were alleviated and recovered to some different extendThe study was to brush bronchial basal cells through fiberbronchoscopy in COPD patients and cultured in vitro and then through the bronchoscope transfusion to the lesion site To preliminary evaluate the efficacy and safety of autologous bronchial basal cells in the treatment of chronic obstructive pulmonary disease
Detailed Description:
Between November 2016 and November 2019 the investigators initially recruited 20 with stable COPD patients Primary evaluations including medical history physical examination anthropometric data blood routine blood biochemistry blood coagulation electrocardiogramhigh resolution chest CT arterial blood gas pulmonary function test6-min walking test6MWTmodified medical research councilMMRCSt Georges respiratory questionnaireSGRQ After initial evaluation the investigators obtained extraction bronchial basal cells micro tissue from 34 grade bronchus to by mean of fiberbronchoscopy then purified and selectively amplified bronchial basal cells to reserve The basal layer cell culture system for our partners Regend Therapeutics patented technology using culture medium containing special combination of growth factors and composite materials to simulated composite basal layer environment and can selectively amplified bronchial basal cells while other types of mature epithelial cells and fibroblasts could not grow naturally After a period of time the basal lamina of the bronchial epithelial cells can be stored in the liquid nitrogen cell bank for a long time Before applied to the patient bronchial basal cells need to go through a series of strict examination Then bronchoscopy was performed again and the bronchial basal lamina suspension was injected directly into the lesion site Estimate the change of respiratory functionsymptoms signs chest CT pulmonary function the 6 minute walk test MMRC SGRQ etc and serum index in third days first months third months sixth months and first years of the follow-up after treatment respectively to evaluate the safety and efficiency of autologous bronchial basal cells for treatment of COPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None