Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula (ALLO-ASC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Anterogen Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01440699
First received: September 19, 2011
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.

Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.

However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.


Condition Intervention Phase
Crohn
Biological: Allogenic human adipose-derived stem cells
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Dose Escalation of Human Allogenic Adipose-derived Stem Cells (ALLO-ASC) to Evaluate Safety and Efficacy in Patients With Crohn's Fistula

Resource links provided by NLM:


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

Primary Outcome Measures:
  • General safety (Laboratory screening, adverse effects, immunological response, local tolerance) [ Time Frame: Week8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients with sustained efficacy [ Time Frame: Month 8 ] [ Designated as safety issue: No ]
    Proportion of patients with more than 50% healed fistula at Month 8 Following up whether there is a recurrence at Month 8

  • Proportion of patients with adverse effects [ Time Frame: at month 8 ] [ Designated as safety issue: Yes ]
    Evaluate the safety at 8 months whether any kind of AE occurs.


Estimated Enrollment: 6
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
For ALLO-ASC 1xE7 cells/ml,3 patients are to be enrolled. If there is no safety issue, 3 more patients will be enrolled to be treated with ALLO-ASC 3xE7 cells/ml.
Biological: Allogenic human adipose-derived stem cells
ALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL.
Other Names:
  • Allogenic human adipose-derived stem cells
  • ALLO-ASC

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Crohn's disease
  • Crohn's fistula which has been lasted at least for 3 months
  • Negative for beta-HCG pregnancy test

Exclusion Criteria:

  • Medical history with Variant Creutzfeldt Jacobs Disease
  • Allergic to anesthetics or bovine protein or fibrin glue
  • autoimmune disease other than Crohn's disease
  • Infectious disease
  • Sepsis or active tuberculosis
  • pregnant or breast feeding woman
  • Inflammatory Bowel disease other than Crohn's disease
  • active crohn's disease with CDAI score > 200
  • malignant tumor
  • fistula's diameter > 2 cm
  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: NCT01440699

Locations
Korea, Republic of
Yeonsei Medical Center Recruiting
Seoul, Korea, Republic of
Contact: TI Kim, MD, PhD    82-2-2228-5170      
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: KJ Park, MD, PhD    82-2-2072-2321      
Keonghee Medical Center Recruiting
Seoul, Korea, Republic of
Contact: HJ Kim, MD, PhD    82-2-958-9996      
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
Principal Investigator: TI Kim, MD, PhD Yeonsei Medical Center
  More Information

No publications provided

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT01440699     History of Changes
Other Study ID Numbers: ALLO-ASC-101
Study First Received: September 19, 2011
Last Updated: September 23, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Anterogen Co., Ltd.:
Crohn's fistula

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014