drugset / Trial / NCT04189419

Safety and Efficacy of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis

NCT04189419 ↗

Phase 1/2 Completed 36 enrolled SCM Lifescience Co., LTD.
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

EvaluationDrugModalityDoseRoute
Subject SCM-AGH Cell therapy 1e+06 cells/kg Intravenous

Indications