Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)

Terminated

• Conditions: Primary; Complex; Perianal Fistula
• Interventions: Biological: Autologous adipose derived stem cells(low dose group); Biological: Autologous adipose derived stem cells(high dose group)

• Registration Number: NCT01623453
• Lead Sponsor: Anterogen Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2012-06
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-17
• Study First Posted: 2012-06-20
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low dose group	Autologous adipose derived stem cells(low dose group)	Group1. Low dose group
High dose group	Autologous adipose derived stem cells(high dose group)	Group2. High dose group

Primary Outcome Measures

Name	Time	Method
Number of patients with Sustained efficacy of complete closure of fistula	Month 4	Proportion of patients with completely closed of fistula (Month 4)

Secondary Outcome Measures

Name	Time	Method
Evaluation of Fecal Incontinence Score	Month 4	Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System)
Number of patients with adverse events as a measure of systemic tolerance and physical examinations	Month 2, 4	1. systemic tolerance (Month 4) (Biochemistry: Albumin, Alkaline phosphatase, ALT, AST, Bilirubin, Calcium, Chloride, Bicarbonate, Creatinine, Glucose, LDH, Potassium, Sodium, Total protein, Urea nitrogen(BUN), Uric acid / Hematology: Hemoglobin, Hematocrit, Reticulocyte count, complete blood cell count with differential, platelet count, WBC with differential count, ESR, PT/APTT); 2. Physical examination; 3. Pregnancy testing (Month 4)
Number of patients with sustained efficacy of closure of fistula	Month 2, 4	Proportion of patients with completely closed of fistula (Month 2); Proportion of patients with more than 50% closed of fistula (Month 2, 4)
Grade of Investigator's satisfaction	Month 2, 4	Grade of Investigator's satisfaction (Month 2, 4); 1. very satisfied; 2. satisfied; 3. moderately satisfied; 4. dissatisfied; 5. very dissatisfied

Trial Locations

Locations (2)

DaeHang Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of