drugset / Trial / NCT06081621
A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)
Phase 2
Completed
23 enrolled
Regend Therapeutics
Peking Union Medical College Hospital · collabRenJi Hospital · collabRuijin Hospital · collabSecond Affiliated Hospital of Xiamen Medical College · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of lung tissues. REGEND001 is a cell therapy product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to IPF treatment. This is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase II clinical study to evaluate the efficacy and safety of REGEND001 in IPF patients.
Timeline
- Start
- 2023-12-11
- Primary completion
- 2025-03-14
- Completion
- 2025-03-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REGEND001 | Cell therapy | 1e+06 cells/kg | Other |
| Subject | REGEND001 | Cell therapy | 1.5e+06 cells/kg | Other |