Allogeneic Mesenchymal Stem Cell for Graft-Versus-Host Disease Treatment

Phase 1

• Conditions: Graft-Versus-Host Disease

• Registration Number: NCT00749164
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Now it is commonly accepted that MSC produce an immune-tolerant environment in different settings. It has been shown (mainly for BM-MSC) that MSC can down-regulate T cells activation. This characteristic of BM derived MSC already has clinical implications and shows their potent effectiveness both in prophylaxis and treatment of resistant GvHD. Ongoing clinical trials of use bone marrow MSC for treatment of steroid resistant GvHD are successfully run on and some bone marrow donor registries included BM-MSC as a material for donation. According to our preclinical studies MSC from cells from marrow, placenta, umbilical cord vessels demonstrate similar pronounced immunosuppressive effect both with autologous and allogeneic lymphocytes. Our preliminary clinical experience shows that BM-MSC is an effective tool for treatment of steroid resistant GVHD. Present study aimed to demonstrate if human UC-MSC has in vivo immunosuppressive effect and can be used for GVHD treatment

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-10
• Last Update Posted: 2009-08-11
• Study Start: 2009-09
• Primary Completion: 2012-02
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
GVHD re-staging and/or GVHD mortality ,side effects	within the first 30 days (plus or minus 3 days) after MSC transplantation

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel