Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
ALLO-ASC
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
1 other identifier
interventional
6
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 19, 2011
CompletedFirst Posted
Study publicly available on registry
September 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2012
CompletedAugust 25, 2023
September 1, 2011
1.1 years
September 19, 2011
August 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
Week8
Secondary Outcomes (2)
Proportion of patients with sustained efficacy
Month 8
Proportion of patients with adverse effects
at month 8
Study Arms (1)
Treatment
EXPERIMENTALFor 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with Crohn's disease
- Crohn's fistula which has been lasted at least for 3 months
- Negative for beta-HCG pregnancy test
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Keonghee Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yeonsei Medical Center
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
TI Kim, MD, PhD
Yeonsei Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2011
First Posted
September 26, 2011
Study Start
September 1, 2011
Primary Completion
October 11, 2012
Study Completion
November 8, 2012
Last Updated
August 25, 2023
Record last verified: 2011-09