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.
Study Type
OBSERVATIONAL
Enrollment
6
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.
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.
DaeHang Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Number of patients with Sustained efficacy of complete closure of fistula
Proportion of patients with completely closed of fistula (Month 4)
Time frame: Month 4
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)
Time frame: Month 2, 4
Evaluation of Fecal Incontinence Score
Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System)
Time frame: Month 4
Grade of Investigator's satisfaction
Grade of Investigator's satisfaction (Month 2, 4) 1. very satisfied 2. satisfied 3. moderately satisfied 4. dissatisfied 5. very dissatisfied
Time frame: Month 2, 4
Number of patients with adverse events as a measure of systemic tolerance and physical examinations
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)
Time frame: Month 2, 4
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