Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)
- Conditions
- Primary; ComplexPerianal Fistula
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
- 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
DaeHang Hospital🇰🇷Seoul, Korea, Republic of