Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT06164093
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow-up Study of Autologous Transplantation of P63+ Lung Progenitor Cells for Treatment of Bronchiectasis
Sponsor:
Ruijin Hospital
Organization:
Study Overview
Official Title:
Follow-up Study of Autologous Transplantation of P63+ Lung Progenitor Cells for Treatment of Bronchiectasis
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This is the follow-up study of autologous transplantation of P63+ lung progenitor cells (LPCs) for treatment of bronchiectasis (NCT03655808). Bronchiectasis is the consequence of chronic suppurative inflammation and fibrosis of the bronchial tubes and the surrounding lung tissues. This seriously damages the muscular and elastic tissues of the bronchial walls, leading to deformation and permanent dilatation of the bronchial tubes. Histopathological damage to the patient's lungs is irremediable. However, there is no effective drug for rebuilding the damaged lung tissue structure, and thus cannot fully restore normal lung function. Lung progenitor cells, located in the basal position of the bronchial epithelium, express the P63 and Keratin-5 (KRT5) marker genes. These cells are active in division and migration, continuously generating new cells to replace other types of dead epithelial cells. They exhibit functional plasticity and can directly repair bronchial and alveolar structures. P63+ LPCs can be extracted by fibreoptic brushing and then isolated, purified and expanded on a large scale using appropriate methods. Currently, preclinical studies and some pilot clinical trials have shown that these cells can successfully repair damaged lungs, improve lung function and have a favourable safety profile. To further investigate the therapeutic mechanism of P63+ LPCs, RNA sequencing will be performed on the remaining LPCs previously transplanted back into the patients. Additionally, to confirm the existence of LPCs in the lung tissue of bronchiectasis patients, the pathological sections of lung tissue samples from patients who had received surgical resection of the lesions, will be subjected to fluorescence staining.
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?:
False
Is an FDA AA801 Violation?: