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

Study Overview
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Brief Summary
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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.

Official Title
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A Follow-up Study to Evaluate the Sustained Healing Effect the Patients Who Showed Complete Closure of Fistula the Previous ANTG-ASC-210 Study

Conditions
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Perianal Fistula, Primary; Complex

Intervention / Treatment
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* Biological: Autologous adipose derived stem cells(low dose group)
* Biological: Autologous adipose derived stem cells(high dose group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low dose group<br>Group1. Low dose group | Biological: Autologous adipose derived stem cells(low dose group)<br>* low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.<br>* Other names: Group 1: low dose group;|
| High dose group<br>Group2. High dose group | Biological: Autologous adipose derived stem cells(high dose group)<br>* high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.<br>* Other names: Group 2: high dose group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Sustained efficacy of complete closure of fistula | Proportion of patients with completely closed of fistula (Month 4) | Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with sustained efficacy of closure of fistula | Proportion of patients with completely closed of fistula (Month 2) Proportion of patients with more than 50% closed of fistula (Month 2, 4) | Month 2, 4 | 
| Evaluation of Fecal Incontinence Score | Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System) | Month 4 | 
| Grade of Investigator's satisfaction | Grade of Investigator's satisfaction (Month 2, 4) very satisfied satisfied moderately satisfied dissatisfied very dissatisfied | Month 2, 4 | 
| Number of patients with adverse events as a measure of systemic tolerance and physical examinations | 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) Physical examination Pregnancy testing (Month 4) | Month 2, 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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crohn's disease, fistula, complex