NCT00447460

Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell

A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: University of Salamanca · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.

Detailed description

This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10\^6 MSC/Kg recipient´s bodyweight). MSC will be infused, by a central venous catheter, to patients diagnosed with GVHD refractory to first-line or subsequent treatment. All patients will receive the same treatment. MSC suspension will be obtained from the bone marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with autologous donor´s serum and with no animal-derived products.

Conditions

• Graft-vs-Host Disease (GVHD)

Interventions

Type	Name	Description
PROCEDURE	Mesenchymal stem cell (MSC)

Timeline

• Start date: 2007-01-01
• Completion: 2009-08-01
• First posted: 2007-03-14
• Last updated: 2007-03-22

Locations

4 sites across 1 country: Spain