Trials / Completed
CompletedNCT06081621
A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)
A Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy in Idiopathic Pulmonary Fibrosis (IPF) Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Regend Therapeutics · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | REGEND001 | REGEND001: 1-1.5×10\^6 bronchial basal cells/kg administrated by bronchoscopy. |
| BIOLOGICAL | Placebo | Placebo: Sodium chloride injection administrated by bronchoscopy. |
Timeline
- Start date
- 2023-12-11
- Primary completion
- 2025-03-14
- Completion
- 2025-03-14
- First posted
- 2023-10-13
- Last updated
- 2026-03-18
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06081621. Inclusion in this directory is not an endorsement.