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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Santa Creu i Sant Pau Hospital
Barcelona, Barcelona, Spain
RECRUITINGClinic i Provincial Hospital
Barcelona, Barcelona, Spain
RECRUITINGUniversity Clinic of Navarra
Navarra, Pamplona, Spain
RECRUITINGDetermine 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).
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University Hospital of Salamanca
Salamanca, Salamanca, Spain
RECRUITING