drugset / Trial / NCT02000362

Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)

NCT02000362

Phase 1/2 Unknown 24 enrolled Kang Stem Biotech Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with moderately active Crohn's disease after injection for 28days. The purpose of phase IIa clinical trial is to determine therapeutic safety and efficacy of FURESTEM-CD Inj. which is based on Crohn's disease activity index(CDAI)\<150 after injection.

Timeline

Start
2014-08
Primary completion
2018-09
Completion
2018-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexlemestrocel-L Cell therapy 5e+07 cells
Subject Rexlemestrocel-L Cell therapy 1e+08 cells

Indications