Clinical trial
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
Name
ALLO-ASC-101
Description
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 arms
Trial start
2011-09-01
Estimated PCD
2012-10-11
Trial end
2012-11-08
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Treatment
Other names:
ALLO-ASC
Size
6
Primary endpoint
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
Week8
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}
Updated at
2023-08-25
1 organization
1 product
1 indication
Organization
AnterogenIndication
Crohn