Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
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|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)|
|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447460
|Contact: Mercedes Comas, CRA||+(034)915545476 ext firstname.lastname@example.org|
|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|