An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease

NCT02000362 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	Kang Stem Biotech Co., Ltd.
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	24
Start date	2014-08
Completion	2018-10

Conditions

• Crohn's Disease

Interventions

• Stem cells

Primary outcomes

• Number of Participants with Adverse Events, Ratio of patients who is applicable to CDAI<150 — 4 weeks follow-up after treatment, 12 weeks follow-up after treatment
  on phase 1, Phase 2a

Countries

South Korea