Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date November 11, 2015
First Posted Date October 6, 2016
Last Update Posted Date September 6, 2017
Study Start Date November 2015
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2017)
all kinds of adverse events which occur during the clinical sutdy [ Time Frame: 114 weeks ]
Safety outcome
Original Primary Outcome Measures
 (submitted: October 5, 2016)
  • ratio of patients who is applicable to CDAI<150 [ Time Frame: 114 weeks ]
  • all kinds of adverse events which occur during the clinical sutdy [ Time Frame: 114 weeks ]
Change History Complete list of historical versions of study NCT02926300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 1, 2017)
  • ratio of patients who is applicable to CDAI<150 [ Time Frame: 114 weeks ]
    Efficacy outcome
  • ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7) [ Time Frame: 114 weeks ]
    Efficacy outcome
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)
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
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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Gender: Both Age Limits: 19years to 70years Healthy Volunteers?: No.
Condition Crohn's Disease
Intervention Biological: stem cells
IV infusion
Other Name: FURESTEM-CD Inj.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 5, 2016)
24
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eun-ji Kang ejkang@kangstem.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02926300
Other Study ID Numbers KSTHD_FURESTEM-CD-EXT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kang Stem Biotech Co., Ltd.
Study Sponsor Kang Stem Biotech Co., Ltd.
Collaborators Not Provided
Investigators
Principal Investigator: Suk-kyun Yang Asan Medical Center
PRS Account Kang Stem Biotech Co., Ltd.
Verification Date September 2016