Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001
NCT05657184 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-07-08
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
Interventions
- DRUG
-
REGEND001
Transplantation of REGEND001 for dose escalation.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
collaborator OTHER -
Ruijin Hospital
collaborator OTHER -
The First Affiliated Hospital of Guangzhou Medical University
collaborator OTHER -
Regend Therapeutics XLotus (Jiangxi) Co, Ltd.
collaborator UNKNOWN -
Regend Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-19
- Primary Completion
- 2023-06-09
- Completion
- 2023-06-09
Countries
- China
Study Locations
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