Long-term Safety and Efficacy of FURESTEM-CD Inj. in Pati... | NCT02926300

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

NCT02926300

Sponsor

Kang Stem Biotech Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 6, 2017Actual

Enrollment

24Estimated

Phase

Not provided

Conditions

Crohn's Disease

Interventions

stem cells

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Oct 2021Estimated

Completion Date

Nov 2021Estimated

First Submitted Date

Nov 11, 2015

First Submission Date that Met QC Criteria

Oct 5, 2016

First Posted Date

Oct 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2017

Last Update Posted Date

Sep 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Name	Type	Description	Arm Group Labels	Other Names
stem cells	Biological	IV infusion		FURESTEM-CD Inj.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eun-ji Kang	Contact			ejkang@kangstem.com

Overall Officials

Name	Affiliation	Role
Suk-kyun Yang	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje University Haeundae Paik Hospital	Recruiting	Busan		48108	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D015212	Inflammatory Bowel Diseases
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided