Back to resultsStudy of Allogenic Adipose-derived Stem Cells in Crohn's Fistula (ALLO-ASC)
Primary Purpose
Crohn
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Allogenic human adipose-derived stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Crohn focused on measuring Crohn's fistula
Eligibility 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
Sites / Locations
- Keonghee Medical Center
- Seoul National University Hospital
- Yeonsei Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
Secondary Outcome Measures
Proportion of patients with sustained efficacy
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
Evaluate the safety at 8 months whether any kind of AE occurs.
Full Information
NCT ID
NCT01440699
First Posted
September 19, 2011
Last Updated
August 23, 2023
Sponsor
Anterogen Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01440699
Brief Title
Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
Acronym
ALLO-ASC
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 11, 2012 (Actual)
Study Completion Date
November 8, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anterogen Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn
Keywords
Crohn's fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Allogenic human adipose-derived stem cells
Other Intervention Name(s)
ALLO-ASC
Intervention Description
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.
Primary Outcome Measure Information:
Title
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
Time Frame
Week8
Secondary Outcome Measure Information:
Title
Proportion of patients with sustained efficacy
Description
Proportion of patients with more than 50% healed fistula at Month 8 Following up whether there is a recurrence at Month 8
Time Frame
Month 8
Title
Proportion of patients with adverse effects
Description
Evaluate the safety at 8 months whether any kind of AE occurs.
Time Frame
at month 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TI Kim, MD, PhD
Organizational Affiliation
Yeonsei Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keonghee Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeonsei Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
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