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An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease

NCT01090817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-06-09

No results posted yet for this study

Summary

Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using third party human cultured cells will be safe and effective

Conditions

  • Crohn Disease

Interventions

DRUG

Mesenchymal stromal cells (MSC) for infusion

MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks

Sponsors & Collaborators

  • The Queen Elizabeth Hospital

    collaborator OTHER

  • Concord Hospital

    collaborator OTHER

  • Sir Charles Gairdner Hospital

    collaborator OTHER

  • The Alfred

    collaborator OTHER

  • R.P.Herrmann

    lead OTHER

Principal Investigators

  • Geoff Forbes, MD · Royal Perth Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-06-30
Completion
2015-06-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01090817 on ClinicalTrials.gov