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Completed

NCT Number: NCT01440699

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

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.

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Key information

Conditions

Crohn

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Keonghee Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogenic human adipose-derived stem cells

Biological

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

Primary outcomes

  1. General safety (Laboratory screening, adverse effects, immunological response, local tolerance)

    Time frame: Week8

Secondary outcomes

  1. Proportion of patients with sustained efficacy

    Time frame: Month 8

    Proportion of patients with more than 50% healed fistula at Month 8 Following up whether there is a recurrence at Month 8

  2. Proportion of patients with adverse effects

    Time frame: at month 8

    Evaluate the safety at 8 months whether any kind of AE occurs.

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study 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

Acronym: ALLO-ASC

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 26, 2011
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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