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

November 21, 2016 updated by: Anterogen Co., Ltd.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • DaeHang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

• the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low dose group
Group1. Low dose group
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.
Other Names:
  • mesenchymal stem cell, ANTG-ASC, adipose derived stem cell
  • Group 1: low dose group
High dose group
Group2. High dose group
Biological: 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.
Other Names:
  • mesenchymal stem cell, ANTG-ASC, adipose derived stem cell
  • Group 2: high dose group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Sustained efficacy of complete closure of fistula
Time Frame: Month 4
Proportion of patients with completely closed of fistula (Month 4)
Month 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with sustained efficacy of closure of fistula
Time Frame: 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)
Month 2, 4
Evaluation of Fecal Incontinence Score
Time Frame: Month 4
Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System)
Month 4
Grade of Investigator's satisfaction
Time Frame: Month 2, 4

Grade of Investigator's satisfaction (Month 2, 4)

  1. very satisfied
  2. satisfied
  3. moderately satisfied
  4. dissatisfied
  5. very dissatisfied
Month 2, 4
Number of patients with adverse events as a measure of systemic tolerance and physical examinations
Time Frame: 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)
Month 2, 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterogen Co., Ltd.

Investigators

  • Principal Investigator: KJ Park, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 17, 2012

First Posted (ESTIMATE)

June 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTG-ASC-211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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