Clinical trial NCT01623453: Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)
Official title: A Follow-up Study to Evaluate the Sustained Healing Effect the Patients Who Showed Complete Closure of Fistula the Previous ANTG-ASC-210 Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Perianal Fistula
Primary; Complex
Keywords: crohn's disease
fistula
complex
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials

Brief summary: This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial.


Eligibility criteria: Inclusion Criteria:

* the patients who have participated in ANTG-ASC-210 clinical trial
* the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
* the patients who submit written informed consents and is able to obey requirements of trials

Exclusion Criteria:

* 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 a symptom of septicemia or active tuberculosis (contain tuberculosis of anus and rectum)
* a patient who is pregnant or breast feeding
* a patient who is not willing to use effective contraceptive methods during the study
* a patient who has inflammatory Bowel disease
* a patient who is sensitive to fibrin glue
* a patient who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker (who smoked more than 20 cigarettes a day)
* a patient who is not able to understand the objective of this study or to comply with the study requirements
* a patient who is considered to have a significant disease which can impact the study by investigator
* a patient who is considered not suitable for the study by investigator
* a patient who had a history of surgery for malignant tumor within the last five years (except carcinoma in situ)
* a patient who has multisystemic wasting syndrome (such as tuberculosis, Diabetes, Thyroid disorders, tumor, etc.)
* a patient who has taken cytotoxic drugs (such as immunosuppressants, corticosteroid, cytotoxic chemotherapy, anticoagulants, etc.) during long-term

Primary outcomes:
measure: Number of patients with Sustained efficacy of complete closure of fistula
timeFrame: Month 4
Secondary outcomes:
measure: Number of patients with sustained efficacy of closure of fistula
timeFrame: Month 2, 4
measure: Evaluation of Fecal Incontinence Score
timeFrame: Month 4
measure: Grade of Investigator's satisfaction
timeFrame: Month 2, 4
measure: Number of patients with adverse events as a measure of systemic tolerance and physical examinations
timeFrame: Month 2, 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: DaeHang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: KJ Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Daehang Hospital
name: DS Kim
role: PRINCIPAL_INVESTIGATOR
References: