NCT05657184

Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001

An Open-label Clinical Study to Explore the Safety, Tolerability and Preliminary Efficacy of REGEND001 for Treatment of Idiopathic Pulmonary Fibrosis (IPF).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Regend Therapeutics · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Idiopathic pulmonary fibrosis (IPF) is a condition where the lungs are damaged and scarred with unknown reason, making breathing becomes increasingly difficult.. REGEND001, made from airway basal cells with ability to regenerate lung tissue, is promising to IPF treatment. In this study, a single-armed clinical trial is ongoing to assess the safety and tolerability of REGEND001 in treatment of IPF. Different doses of REGEND001 is evaluated to establish a dose-response relationship and to suggest appropriate dose for subsequent clinical trials.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	REGEND001	Transplantation of REGEND001 for dose escalation.

Timeline

• Start date: 2021-07-19
• Primary completion: 2023-06-09
• Completion: 2023-06-09
• First posted: 2022-12-20
• Last updated: 2024-07-08

Locations

3 sites across 1 country: China