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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Anterogen Co., Ltd..
Recruitment status was  Active, not recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 22, 2014