Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)
- Conditions
- Crohn's Disease
- Registration Number
- NCT02926300
- Lead Sponsor
- Kang Stem Biotech Co., Ltd.
- Brief Summary
The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.
- Detailed Description
This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- patients who has history of FURESTEM-CD Inj. injection at least once.
- patients who understand and voluntarily sign an informed consent form.
- any other condition which the Principle Investigator judges would make subject unsuitable for study participation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method all kinds of adverse events which occur during the clinical sutdy 114 weeks Safety outcome
- Secondary Outcome Measures
Name Time Method ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7) 114 weeks Efficacy outcome
ratio of patients who is applicable to CDAI<150 114 weeks Efficacy outcome
Trial Locations
- Locations (7)
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National Universtiy Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Soeul National University Hospital
🇰🇷Soeul, Korea, Republic of
The Catholic University of Korea, St. Vincent'S Hospital.
🇰🇷Suwon-si, Korea, Republic of