Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
|ClinicalTrials.gov Identifier: NCT00447460|
Recruitment Status : Unknown
Verified March 2007 by University of Salamanca.
Recruitment status was: Recruiting
First Posted : March 14, 2007
Last Update Posted : March 22, 2007
|Condition or disease||Intervention/treatment||Phase|
|Graft-vs-Host Disease (GVHD)||Procedure: Mesenchymal stem cell (MSC)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2007|
|Estimated Study Completion Date :||August 2009|
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447460
|Contact: Mercedes Comas, CRA||+(034)915545476 ext email@example.com|
|University Clinic of Navarra||Recruiting|
|Navarra, Pamplona, Spain, 31080|
|Principal Investigator: José Rifón Roca, MD|
|Santa Creu i Sant Pau Hospital||Recruiting|
|Barcelona, Spain, 08025|
|Principal Investigator: David Varcárcel Ferrerías, MD|
|Clinic i Provincial Hospital||Recruiting|
|Barcelona, Spain, 08036|
|Principal Investigator: Carmen Martínez Muñoz, MD|
|University Hospital of Salamanca||Recruiting|
|Salamanca, Spain, 37007|
|Principal Investigator: Consuelo del Cañizo, MD|
|Principal Investigator: José A Pérez-Simón, MD|
|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|