NCT06164093

Follow-up Study of Autologous Transplantation of P63+ Lung Progenitor Cells for Treatment of Bronchiectasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
OTHER	RNA sequencing is performed on the remaining LPCs	RNA sequencing is performed on the remaining LPCs previously transplanted back into the patients. And the results are analysed combined with the data from the previous clinical trial. (Please note that patients will not receive cell transplantation again as they have already received the treatment in the previous trial \[NCT03655808\])
OTHER	Immunofluorescence staining is performed in the surgically resected lung tissue sections	The aim of this intervention is to detect Krt5 protein expression by staining the surgically resected lung tissue sections. This is done to confirm the presence of a small number of LPCs in the lung tissue of patients with bronchiectasis and to investigate their distribution.

Timeline

• Start date: 2023-12-12
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2023-12-11
• Last updated: 2024-10-09

Locations

1 site across 1 country: China