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

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ClinicalTrials.gov Identifier: NCT02926300
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Crohn's Disease Biological: stem cells

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
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : November 2015
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease


Intervention Details:
  • Biological: stem cells
    IV infusion
    Other Name: FURESTEM-CD Inj.


Primary Outcome Measures :
  1. all kinds of adverse events which occur during the clinical sutdy [ Time Frame: 114 weeks ]
    Safety outcome


Secondary Outcome Measures :
  1. ratio of patients who is applicable to CDAI<150 [ Time Frame: 114 weeks ]
    Efficacy outcome

  2. ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7) [ Time Frame: 114 weeks ]
    Efficacy outcome



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Gender: Both Age Limits: 19years to 70years Healthy Volunteers?: No.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926300


Contacts
Contact: Eun-ji Kang ejkang@kangstem.com

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

Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02926300     History of Changes
Other Study ID Numbers: KSTHD_FURESTEM-CD-EXT
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2016

Keywords provided by Kang Stem Biotech Co., Ltd.:
crohn's disease
stem cell therapy
inflammatory bowel disease
hUCB-MSC
UCB-MSC
Umbilical cord Blood
Rheumatoid Arthritis
RA
Stem cell
Cell therapy
Furestem
Mesenchymal stem cell
MSC

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases