MedTrace Logo

Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders

NCT01540292 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-05-12

No results posted yet for this study

Summary

This project aims to assess safety and efficacy of allogeneic Mesenchymal stem Cell (MSC) in Crohn's disease refractory or intolerant to conventional therapies. Twenty patients with active refractory Crohn's disease defined by a Crohn's Disease Activity Index (CDAI) \> 220 despite conventional treatment will be included over 4 years in this phase I-II trial. This will be a pilot open label trial. Patients will be treated with 2 successive injections of allogeneic MSC at baseline and 4 weeks later. Patients will be followed up at weeks 2, 4, 8 and 12.

Conditions

Interventions

BIOLOGICAL

Mesenchymal Stem Cells (MSC)

MSC (1.5-2 cells/kg BW) IV injection, twice at 4 weeks apart

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Principal Investigators

  • Yves Beguin, MD, PhD · CHU-ULg

  • Edouard Louis, MD, PhD · CHU-ULg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT01540292 on ClinicalTrials.gov