Efficacy and Safety of Direct Intrabone Transplantation of Peripheral Blood Haematopoietic Stem Cells Form HLA-matched Sibling Donors in Patients With Myeloid and Lymphoid Malignancies.
Allogenic haematopoietic stem cell transplantation is an established treatment option for
haematologic malignancies, especially leukaemias and lymphomas, providing curative
potential. The optimal donor is HLA-matched sibling and G-CSF stimulated peripheral blood is
nowadays the most common source of stem cells. Routinely used route of stem cell
transplantation is intravenous infusion via central venous catheter. Based on the animal
studies, only 10-15% of intravenously transplanted stem cells migrate to haematopoietic
sites while the rest is lost in other organs. Results of studies of direct intrabone
allogenic cord-blood cells transplantation in humans confirm that this route of
transplantation is associated with less probability of graft failure and moreover may reduce
risk of graft-versus-host disease and malignancy relapse. For those purposes in the current
study we investigate intrabone route of allogenic peripheral blood stem cell
transplantation. Our intention is to achieve fast engraftment and minimize risk of relapse
and graft graft-versus-host disease.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Neutrophil engraftment (ANC > 0,5 G/l)
28 days
No
Tomasz Czerw, MD
Principal Investigator
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
Poland: Ethics Committee
IBT-COI-01
NCT01728389
November 2012
April 2014
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