drugset / Trial / NCT04189419
Safety and Efficacy of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study consists of two phases (Phase I and Phase IIa). Phase IIa will be conducted sequentially after the safety of SCM-AGH is secured in Phase I. * Phase I: Multicenter in Korea, Non-Randomized, Open-label, Single Arm, 3+3 design) for Severe Acute Pancreatitis * Phase II: Multicenter in Korea, Randomized, Double-blind, 2-arm, Placebo-controlled, Parallel arm for Moderate to Severe Acute Pancreatitis
Timeline
- Start
- 2019-08-12
- Primary completion
- 2022-01-14
- Completion
- 2022-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCM-AGH | Cell therapy | 1e+06 cells/kg | Intravenous |