Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula (ALLO-ASC)

August 23, 2023 updated by: Anterogen Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Keonghee Medical Center
      • Seoul, Korea, Republic of
        • Yeonsei Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 8
Proportion of patients with adverse effects
Time Frame: at month 8
Evaluate the safety at 8 months whether any kind of AE occurs.
at month 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterogen Co., Ltd.

Investigators

  • Principal Investigator: TI Kim, MD, PhD, Yeonsei Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 11, 2012

Study Completion (Actual)

November 8, 2012

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimated)

September 26, 2011

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-ASC-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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