Clinical trial NCT01314092: Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula
Official title: Phase II Study to Evaluate Efficacy and Safety of ANTG-ASC (Autologous Cultured Adipose-derived Stem Cells) on the Complex Fistula Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Complex Perianal Fistula
Keywords: crohn's disease
fistula
complex
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* a patient who has complex perianal fistula
* a patient who is negative in pregnancy test
* a patient who has submitted a written consent

Exclusion Criteria:

* a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
* a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
* a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
* a patient who has an autoimmune disease
* a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
* a patient who has sepsis or active tuberculosis
* a patient who is pregnant or breast feeding
* a patient who has inflammatory Bowel disease
* over 2cm in diameter of fistula

Primary outcomes:
measure: Number of patients with complete closure of fistula (week 8)
timeFrame: 8 weeks
Secondary outcomes:
measure: Grade of investigator's satisfaction
timeFrame: 8 weeks
measure: Number of patients with closed fistula
timeFrame: 8 weeks
measure: Photo of target fistula
timeFrame: 8 weeks
measure: Number of patients with adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Soon cheun Hyang university bucheon hospital
city: Seoul
country: Korea, Republic of
facility: Ewha womwn university mokdong hospital
city: Seoul
country: Korea, Republic of
facility: DaeHang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: KJ Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daehang Hospital
name: DS Kim
role: PRINCIPAL_INVESTIGATOR
References: