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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01440699

Acronym

ALLO-ASC

Enrollment

Registered

2011-09-26

Start date

2011-09-30

Completion date

2012-11-08

Last updated

2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn

Keywords

Crohn's fistula

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.

Interventions

BIOLOGICALAllogenic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)	Week8

Secondary

Measure	Time frame	Description
Proportion of patients with sustained efficacy	Month 8	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	at month 8	Evaluate the safety at 8 months whether any kind of AE occurs.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026