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

Perianal Fistula Clinical Trial

— ANTG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01623453
• Other study ID #: ANTG-ASC-211
• Status: Terminated
• Phase: N/A
• First received: June 8, 2012
• Last updated: November 21, 2016
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: June 2012
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Fistula
• Perianal Fistula
• Primary; Complex

Intervention

Biological:
• Autologous 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.
• Autologous 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.

Locations

Country	Name	City	State
Korea, Republic of	DaeHang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Sustained efficacy of complete closure of fistula	Proportion of patients with completely closed of fistula (Month 4)	Month 4	No
Secondary	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	No
Secondary	Evaluation of Fecal Incontinence Score	Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System)	Month 4	No
Secondary	Grade of Investigator's satisfaction	Grade of Investigator's satisfaction (Month 2, 4); very satisfied; satisfied; moderately satisfied; dissatisfied; very dissatisfied	Month 2, 4	No
Secondary	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	Yes