Trial | NCT01440699  Report issue

Title

Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Crohn

  • Study Participants

    6
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.
Study Started
Sep 30
2011
Primary Completion
Oct 11
2012
Study Completion
Nov 08
2012
Last Update
Aug 25
2023

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: ALLO-ASC

Treatment Experimental

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.

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
No Results Posted