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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number: 2005-003674-14 |
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| Name | Class |
|---|---|
| Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cell (MSC) | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of infectious complications after MSC infusion. | ||
| Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease. | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mercedes Comas, CRA | Contact | +(034)915545476 | 29 | mercedes.comas@logitest.es |
| Name | Affiliation | Role |
|---|---|---|
| Consuelo del Cañizo, MD | Haematology Service, University Hospital of Salamanca | Study Chair |
| José A Pérez-Simón, MD | Haematology Service, University Hospital of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Creu i Sant Pau Hospital | Recruiting | Barcelona | Barcelona | 08025 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21393326 | Derived | Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10. |
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| Study the influence of MSC infusion on DFS and OS. |
| Determine MSC grafted into the bone marrow (or in other organs). |
| 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 | Principal Investigator |
| Clinic i Provincial Hospital | Recruiting | Barcelona | Barcelona | 08036 | Spain |
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| University Clinic of Navarra | Recruiting | Navarra | Pamplona | 31080 | Spain |
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| University Hospital of Salamanca | Recruiting | Salamanca | Salamanca | 37007 | Spain |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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