Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study to Evaluate Efficacy and Safety of ANTG-ASC (Autologous Cultured Adipose-derived Stem Cells) on the Complex Fistula Patients

Conditions
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Complex Perianal Fistula

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


Participation Criteria
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Eligibility Criteria
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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

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Low dose group | Biological: Autologous cultured 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: Group1: low dose group;|
| Experimental: Group 2<br>high dose group | Biological: Autologous cultured 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: Group2: 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 complete closure of fistula (week 8) | Proportion of patients with completely closed fistula (week 8) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of investigator's satisfaction | Grade of investigator's satisfaction (8 weeks after final dose) very satisfaction satisfaction somewhat satisfaction unsatisfaction very unsatisfaction | 8 weeks | 
| Number of patients with closed fistula | proportion of patients with completely closed fistula (every visits) proportion of patients with more than 50 % closed fistula (every visits) | 8 weeks | 
| Photo of target fistula | Taking picture of target fistula at Day 0 and Week 4, 6, 8 | 8 weeks | 
| Number of patients with adverse events | Number of patients with any kinds of adverse events (Day 0, every visits) | 8 weeks | 

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