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NOT YET RECRUITING
NCT07359963
EARLY_PHASE1

Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND007 Cell Therapy

Sponsor: Regend Therapeutics

View on ClinicalTrials.gov

Summary

This study is a prospective, single-arm, dose-escalation exploratory clinical trial to investigate the safety, tolerability and preliminary efficacy of REGEND007 stem cell preparation administered by intravenous infusion in the treatment of idiopathic pulmonary fibrosis (IPF), with a follow-up period of 12 weeks.

Official title: An Exploratory Clinical Study on the Intravenous Infusion of REGEND007 (Generic Airway Basal Layer Stem Cell Preparation) for the Treatment of Idiopathic Pulmonary Fibrosis (IPF).

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-02-15

Completion Date

2027-06-15

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

BIOLOGICAL

REGEND007 Cell Therapy

This study's intravenous infusion dose escalation protocol is based on a 3+3 dose escalation design, with a total of 4 dose groups. Each group included 3 subjects, and the dose is gradually increased until the maximum tolerated dose(MTD) or the maximum administered dose (MAD) is reached.

Locations (1)

The Fourth Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China