Perianal Fistula, Primary; Complex
Conditions
Keywords
crohn's disease, fistula, complex
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.
Interventions
BIOLOGICALAutologous adipose derived stem cells(low dose group)
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.
BIOLOGICALAutologous adipose derived stem cells(high dose group)
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.
Sponsors
Anterogen Co., Ltd.
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Sustained efficacy of complete closure of fistula | Month 4 | Proportion of patients with completely closed of fistula (Month 4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Evaluation of Fecal Incontinence Score | Month 4 | Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System) |
| 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 |
| 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) |
Countries
South Korea
Outcome results
None listed