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

NCT02000362 | Unknown Phase 1 DMC

• 1 other identifier: KSTHD_FURESTEM-CD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with moderately active Crohn's disease after injection for 28days. The purpose of phase IIa clinical trial is to determine therapeutic safety and efficacy of FURESTEM-CD Inj. which is based on Crohn's disease activity index(CDAI)\<150 after injection.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Stem cell; Cell therapy; Auto-immune disease; furestem; CD; inflammatory bowel disease; MSCs; Mesenchymal Stem Cells; hUCB-MSC; UCB-MSC; Umbilical cord Blood

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events, Ratio of patients who is applicable to CDAI<150

  on phase 1, Phase 2a

  4 weeks follow-up after treatment, 12 weeks follow-up after treatment

Secondary Outcomes (8)

• the ratio of patients who reduce CDAI over 70 as contrasted with baseline value

  12 weeks follow-up after treatment

• a variation of CRP value as contrasted with baseline

  12 weeks follow-up after treatment

• a variation of MR enterographic score as contrasted with baseline

  12 weeks follow-up after treatment

• a variation of fecal calprotectin as contrasted with baseline

  12 weeks follow-up after treatment

• a variation of IBDQ score as contrasted with baseline

  12 weeks follow-up after treatment

Study Arms (1)

Treatment

EXPERIMENTAL

cohort 1. 5.0 x 10\^7 stem cells after registration cohort 2. 1.0 x 10\^8 stem cells after registration

Biological: Stem cells

Interventions

Stem cells BIOLOGICAL

Also known as: FURESTEM-CD Inj.

Treatment

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• of either gender, aged≥19 and ≤70 years
• subjects who is diagnosed with Crohn's disease after considering all the factors below.
• histological or pathological Diagnostic opinion
• colonoscopic Diagnostic opinion
• radiologic and hematological Diagnostic opinion
• subjects who is included in two criteria below and come under CDAI 220-450 during screening period.
• CRP\>0.3mg/dL during screening period
• more than 3 nonanastomotic ulcers which is included in Crohn's disease as a result of colonoscopy on screening period(each diameter of ulcers needs to exceed 0.5cm)
• range of Crohn's disease : an affection of ileum, an affection of large intestine, an affection of ileum and large intestine at once.
• subjects who suffer from extensive colitis during more than 8 years or limited colitis during more than 12 years need to have evidence that there are no large intestine ulcers by surveillance colonoscopy on screening visit.
• subjects who are included in two criteria about drug treatment of Crohn's disease like below.
• subjects who fail the existing treatment and come under more than 1 criterion as below.
• subjects who continuously administer Corticosteroid or immunosuppressant (AZA, Methotrexate, 6-MP)
• subjects who have history of improper response or intolerance about Corticosteroid or immunosuppressant (AZA, Methotrexate, 6-MP)
• subjects who are dependent Corticosteroid or have history of Corticosteroid dependence.

You may not qualify if:

• Crohn's disease which is invaded only proximal ileum.
• the evidence of an intra-abdominal abscess during screening period.
• the evidence of an abscess around the anus during screening period.
• conditions of subtotal colectomy or total colectomy.
• short bowel syndrome.
• subjects who conduct elemental diet, tube feeding or parenteral nutrition within 3 weeks before registration.
• subjects who have ileostomy or colostomy.
• subjects who remove existing seton before screening period.
• fixed bowel stricture which has symptoms.
• In case that the PI anticipate that subjects need to get a surgical intestinal tract surgery caused by Crohn's disease.
• non-removal of large intestine adenoma.
• chronic inflammation-associated dysplasia.
• in case subjects administered more than one drug within 4 weeks before enrollment.
• Cyclosporine, tacrolimus, thalidomide
• Adalimumab

Sponsors & Collaborators

• Kang Stem Biotech Co., Ltd.: lead

Study Sites (7)

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, 42415, South Korea

RECRUITING

Seoul National Universtiy Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Soeul National University Hospital

Soeul, 110-7441, South Korea

RECRUITING

The Catholic University of Korea, St. Vincent'S Hospital.

Suwon, 16247, South Korea

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Suk-kyun Yang

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun-ji Kang

CONTACT

ejkang@kangstem.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: December 4, 2013
• Study Start: August 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: September 6, 2017

Record last verified: 2016-09

Locations

KR (7)