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NCT02926300 Clinical Trial

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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02926300
Other study ID # KSTHD_FURESTEM-CD-EXT
Secondary ID
Status Recruiting
Phase N/A
First received November 11, 2015
Last updated September 5, 2017
Start date November 2015
Est. completion date November 2021

Study information
Verified date September 2016
Source Kang Stem Biotech Co., Ltd.
Contact Eun-ji Kang
Email ejkang@kangstem.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 24
Est. completion date November 2021
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• stem cells
IV infusion

Locations
Country Name City State
Korea, Republic of 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 Asan Medical Center Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of Soeul National University Hospital Soeul
Korea, Republic of The Catholic University of Korea, St. Vincent`S Hospital. Suwon-si

Sponsors (1)
Lead Sponsor Collaborator
Kang Stem Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary all kinds of adverse events which occur during the clinical sutdy Safety outcome 114 weeks
Secondary ratio of patients who is applicable to CDAI<150 Efficacy outcome 114 weeks
Secondary ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7) Efficacy outcome 114 weeks
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