Direct Intra Bone Marrow Injection Of Unrelated Cord Blood Cells To Improve Engraftment And Reduce Acute Graft-Versus-Host Disease
Study Design Phase I-II study. Neutrophil recovery > 80% at day 60 and Platelets recovery >
80% at days 100 are defined as success. The limit of 60 days for neutrophil recovery was
chosen because it represents the time at which rescue with a second transplant is decided in
case of failure to engraft; the day 100 for platelets recovery is taken corresponds to first
form reported after transplant to the European Blood and Marrow Transplant Registry.
HLA-A and -B antigens will be identified by low resolution DNA typing, whereas HLA-DRB1 type
was determined by high resolution DNA typing techniques. HLA-A, HLA-B, and HLA-DRB1 typing
was used to select the most closely matched donor unit-recipient pair, with preference given
to HLA-DRB1-matched unit
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the safety and the probability of neutrophils and platelets recovery after i.b. cord blood transplant.
Full blood count, Monitoring Infections post Transplant, Bone marrow evaluation, Chimerism Analysis, Haematopoietic Reconstitution
francesco frassoni, MD
A.O. San martino
Italy: Ethics Committee