Overview

This trial has been terminated.

Conditions perianal fistula, primary; complex
Treatments autologous adipose derived stem cells(low dose group), autologous adipose derived stem cells(high dose group)
Sponsor Anterogen Co., Ltd.
Start date September 2010
End date September 2014
Trial size 6 participants
Trial identifier NCT01623453, ANTG-ASC-211

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Group1. Low dose group
autologous adipose derived stem cells(low dose group) mesenchymal stem cell, ANTG-ASC, adipose derived stem cell
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.
Group2. High dose group
autologous adipose derived stem cells(high dose group) mesenchymal stem cell, ANTG-ASC, adipose derived stem cell
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.

Primary Outcomes

Measure
Number of patients with Sustained efficacy of complete closure of fistula
time frame: Month 4

Secondary Outcomes

Measure
Number of patients with sustained efficacy of closure of fistula
time frame: Month 2, 4
Evaluation of Fecal Incontinence Score
time frame: Month 4
Grade of Investigator's satisfaction
time frame: Month 2, 4
Number of patients with adverse events as a measure of systemic tolerance and physical examinations
time frame: Month 2, 4

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator KJ Park
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Anterogen Co., Ltd..