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

September 5, 2017 updated by: Kang Stem Biotech Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Inje university Haeundae Paik Hospital
        • Contact:
          • Tae-oh Kim
      • Daegu, Korea, Republic of, 42415
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
          • Byung-Ik Jang
      • Seongnam-si, Korea, Republic of, 13620
        • Recruiting
        • Seoul National Universtiy Bundang Hospital
        • Principal Investigator:
          • Hyuk Yoon
        • Contact:
          • Hyuk Yoon
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
          • Jae-hee Cheon
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Su-jung Kim
        • Contact:
          • Ji-young Park
        • Principal Investigator:
          • Suk-kyun Yang
      • Soeul, Korea, Republic of, 110-7441
        • Recruiting
        • Soeul National University Hospital
        • Contact:
          • Jong-pil Im
        • Principal Investigator:
          • Jong-pil Im
      • Suwon-si, Korea, Republic of, 16247
        • Recruiting
        • The Catholic University of Korea, St. Vincent'S Hospital.
        • Contact:
          • Kang-moon Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Gender: Both Age Limits: 19years to 70years Healthy Volunteers?: No.

Description

Inclusion Criteria:

  • patients who has history of FURESTEM-CD Inj. injection at least once.
  • patients who understand and voluntarily sign an informed consent form.

Exclusion Criteria:

  • any other condition which the Principle Investigator judges would make subject unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all kinds of adverse events which occur during the clinical sutdy
Time Frame: 114 weeks
Safety outcome
114 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ratio of patients who is applicable to CDAI<150
Time Frame: 114 weeks
Efficacy outcome
114 weeks
ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7)
Time Frame: 114 weeks
Efficacy outcome
114 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kang Stem Biotech Co., Ltd.

Investigators

  • Principal Investigator: Suk-kyun Yang, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSTHD_FURESTEM-CD-EXT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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