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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02000362
• Date of registration: 07/11/2013
• Prospective Registration: Yes
• Primary sponsor: Kang Stem Biotech Co., Ltd.
• Public title: Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)
• Scientific title: An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease
• Date of first enrolment: August 2014
• Target sample size: 24
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02000362
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Suk-kyun Yang
• Affiliation: Asan Medical Center

• Name: Eun-ji Kang

Key inclusion & exclusion criteria

Inclusion Criteria:

1. of either gender, aged=19 and =70 years

2. subjects who is diagnosed with Crohn's disease after considering all the factors
below.

1. histological or pathological Diagnostic opinion

2. colonoscopic Diagnostic opinion

3. radiologic and hematological Diagnostic opinion

3. subjects who is included in two criteria below and come under CDAI 220-450 during
screening period.

1. CRP>0.3mg/dL during screening period

2. 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)

4. range of Crohn's disease : an affection of ileum, an affection of large intestine, an
affection of ileum and large intestine at once.

5. 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.

6. subjects who are included in two criteria about drug treatment of Crohn's disease like
below.

1. 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.

2. subjects who have history of improper response or intolerance about anti-TNF
treatment as below.

- Infliximab

- Adalimumab

- Certolizumab pegol

7. subjects who satisfy those clinical examination value below during screening period.

- Hemoglobin = 8.0g/dL

- WBC = 3,000/µL

- Lymphocyte = 500/µL

- 100,000/µL = Platelet = 1,200,000/µL

- AST and ALT = 3 x the upper limit of normal

- ALP = 3 x the upper limit of normal

- Serum creatinine = the upper limit of normal

- Serum albumin = 2.0g/dL

- PT = the upper limit of normal

- aPTT = the upper limit of normal

8. subjects who agree with those use of contraceptive method during clinical trial
period.

1. woman : subjects who is applicable to more than 1 case below.

- subjects who is postmenopausal for more than 1 years before screening visit.

- surgically sterility.

- If subjects are biological clock, subjects need to agree with prohibition on
having sex with man or usage of more than 2 effective contraception from
sign of informed consent form until end of the clinical study.

2. man : even surgically sterility(for example, getting a vasectomy), in case of
satisfy those conditions below.

- subjects who agree with prohibition on having sex with woman or usage of
effective barrier contraception from sign of informed consent form until end
of the clinical study.

9. subjects who understand and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Exclusion Criteria of gastrointestinal tract

1. Crohn's disease which is invaded only proximal ileum.

2. the evidence of an intra-abdominal abscess during screening period.

3. the evidence of an abscess around the anus during screening period.

4. conditions of subtotal colectomy or total colectomy.

5. short bowel syndrome.

6. subjects who conduct elemental diet, tube feeding or parenteral nutrition within
3 weeks before registration.

7. subjects who have ileostomy or colostomy.

8. subjects who remove existing seton before screening period.

9. fixed bowel stricture which has symptoms.

10. In case that the PI anticipate that subjects need to get a surgical intestinal
tract surgery caused by Crohn's disease.

11. non-removal of large intestine adenoma.

12. chronic inflammation-associated dysplasia.

2. Exclusion Criteria of drugs

1. in case subjects administered more than one drug within 4 weeks before
enrollment.

- Cyclosporine, tacrolimus, thalidomide

- Adalimumab

- Intravenous adrenocortical steroid

2. in case subjects administered more than one drug within 10 weeks before
enrollment.

- Infliximab

- Cetolizumab pegol

- All kinds of biologicals

3. in case subjects administered 5-ASA or Corticosteroid local treatment(a
suppository or enema) within 2 weeks before enrollment.

4. in case concomitant drug use for CD treatment cannot observe stable dosage during
clinical study period or specified period like below.

- use of oral 5-ASA compound at least 4 weeks before enrollment

- use of oral Corticosteroid (prednisolone = 20mg/day or budesonide =9mg/day)
at least 2 weeks before enrollment

- use of antibiotics for CD treatment at least 2 weeks before enrollment. (ex.
metronidazole)

- use of immunosuppressant at least 4 weeks before enrollment.

3. Exclusion Criteria of infectious disease

1. acute or chronic hepatitis like below(typeA, typeB, typeC).

- IgM anti-HAV positive

- HBs-Ag, IgM anti-HBc, IgG anti-HBc positive. (It is possible to enroll the
clinical study when a subject is anti-HBs Ab positive, given that the
subject is both HBs-Ag and IgM anti-HBc negative or IgG anti-HBc positive.)

- HCV-Ab positive

2. tuberculosis

- status present active tuberculosis

- latent tuberculosis : subjects who is applicable to more than 1 case below.

- QuantiFERON TB-GOLD positive or 2times continuous indeterminate within
4weeks before registration.

- more than 10mm in tuberculin skin test within 3 months before



Age minimum: 19 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Stem cells

Primary Outcome(s)

Number of Participants with Adverse Events, Ratio of patients who is applicable to CDAI<150 [Time Frame: 4 weeks follow-up after treatment, 12 weeks follow-up after treatment]

Secondary Outcome(s)

a variation of fecal calprotectin as contrasted with baseline [Time Frame: 12 weeks follow-up after treatment]

all kinds of adverse effects which occur during the clinical study [Time Frame: 12 weeks follow-up after treatment]

a variation of MR enterographic score as contrasted with baseline [Time Frame: 12 weeks follow-up after treatment]

a variation of SF-36 score as contrasted with baseline [Time Frame: 12 weeks follow-up after treatment]

reduction of the number of draining fistula [Time Frame: 12 weeks follow-up after treatment]

the ratio of patients who reduce CDAI over 70 as contrasted with baseline value [Time Frame: 12 weeks follow-up after treatment]

a variation of CRP value as contrasted with baseline [Time Frame: 12 weeks follow-up after treatment]

a variation of IBDQ score as contrasted with baseline [Time Frame: 12 weeks follow-up after treatment]

Secondary ID(s)

KSTHD_FURESTEM-CD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors