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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01623453
First received: June 8, 2012
Last updated: June 17, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Perianal Fistula
Primary; Complex
Biological: Autologous adipose derived stem cells

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Anterogen Co., Ltd.:

Primary Outcome Measures:
  • Number of patients with Sustained efficacy of complete closure of fistula [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    Proportion of patients with completely closed of fistula (Month 4)


Secondary Outcome Measures:
  • Number of patients with sustained efficacy of closure of fistula [ Time Frame: Month 2, 4 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    Evaluation of Fecal Incontinence Score (Wexner Score, Cleveland Clinic Continence Scoring System)

  • Grade of Investigator's satisfaction [ Time Frame: Month 2, 4 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Month 2, 4 ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Low dose group
Group1. Low dose group
Biological: Autologous adipose derived stem cells
low dose group: 1x10e7 cells/mL, 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 Name: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell
High dose group
Group2. High dose group
Biological: Autologous adipose derived stem cells
low dose group: 1x10e7 cells/mL, 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 Name: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623453

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
DaeHang Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
Principal Investigator: KJ Park Seoul National University Hospital
Principal Investigator: DS Kim Daehang hospital
  More Information

No publications provided

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT01623453     History of Changes
Other Study ID Numbers: ANTG-ASC-211
Study First Received: June 8, 2012
Last Updated: June 17, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Anterogen Co., Ltd.:
crohn's disease
fistula
complex

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014