NCT03188627

Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

A Single-centered, Non-randomized, Concurrent Control Study on Autologous Bronchial Basal Cell Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Regend Therapeutics · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, expanded cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
BIOLOGICAL	Bronchial basal cells	Transplantation of autologous bronchial basal cells

Timeline

• Start date: 2018-06-12
• Primary completion: 2019-12-26
• Completion: 2019-12-26
• First posted: 2017-06-15
• Last updated: 2023-03-24

Locations

1 site across 1 country: China