Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
Recruitment status was: Recruiting
Graft-vs-Host Disease (GVHD)
Procedure: Mesenchymal stem cell (MSC)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell|
- Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.
- Efficacy will be evaluated in terms of GVHD response.
- Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.
- Evaluation of infectious complications after MSC infusion.
- Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease.
- Study the influence of MSC infusion on DFS and OS.
- Determine MSC grafted into the bone marrow (or in other organs).
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||August 2009|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447460
|University Clinic of Navarra|
|Navarra, Pamplona, Spain, 31080|
|Santa Creu i Sant Pau Hospital|
|Barcelona, Spain, 08025|
|Clinic i Provincial Hospital|
|Barcelona, Spain, 08036|
|University Hospital of Salamanca|
|Salamanca, Spain, 37007|
|Study Chair:||Consuelo del Cañizo, MD||Haematology Service, University Hospital of Salamanca|
|Principal Investigator:||José A Pérez-Simón, MD||Haematology Service, University Hospital of Salamanca|
|Principal Investigator:||David Varcárcel Ferrerías, MD||Haematology Service, Santa Creu i Sant Pau Hospital, Barcelona|
|Principal Investigator:||Carmen Martínez Muñoz, MD||Haematology Service, Clinic i Provincial Hospital, Barcelona|
|Principal Investigator:||José Rifón Roca, MD||Haematology Service, University Clinic of Navarra|