Intra-bone Cord Blood Transplantation
Intra-bone Cord Blood Transplantation
For the great majority of hematological malignancies, hemopoietic stem cell (HSC) transplant
 is the only possible cure. The source of HSC is usually bone marrow (BM) or peripheral blood
 cell (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible donor
 weather related or unrelated. A suitable compatible donor can be found in at least 70% of the
 patients. Thus, at least 30% of patients with indication for allogeneic HSC transplant are
 not able to undergo the procedure because of the lack of a HLA compatible donor. Cord blood
 (CB) cells represent another possible source, that needs a lower degree of HLA compatibility.
 CB transplant, however, offers a lower number of HSC. Thus, adult patient rarely may benefit
 from this source of stem cells, mainly beacuse thie body weight is too high to have ad
 adequate number of cell per kg. Recently, experimental animal models confirmed that an
 adequate recovery of allogeneic hemopoiesis can be achieved via intrabone injection, using a
 1Log lower number of cells compared to the intravenous way (Yahata 2003, Castello 2004).
 Safety and feasibility of intrabone infusion was verified by two clinical studies on humans:
 the first was conducted by Ringden O. et al. in 18 patients using BM as a source of SC. No
 side effects and complete engraftment of donor hemopoiesis was observed; the second one was
 conducted by Frassoni et al. (Frassoni 2008) with CB as the source of HSC.

 The aim of this study is to evaluate the intrabone infusion of compatible CB in patients with
 haematological malignancies lacking a HLA matched donor.

 We will perform:

 evaluation of the engraftment kinetics; evaluation of the chimerism degree at 30, 60, 100
 days, 6 months and 1 year after transplant; studies on immunological reconstitution and the
 role of the NK compartment.
Inclusion Criteria:

 -  Age between 18 and 65 years.

 -  Patients affected by hematological malignancies without a HLA identical sibling donor
 or unrelated donor.

 -  Informed consent.

 Exclusion Criteria:

 -  Patients with ECOG < 2.

 -  Patients with blood creatine > 2 mg/dl or with transaminase or cholestase index > 5
 times compared to normality upper limits.

 -  Patients with Cardiac Fraction Ejection < 40%.

 -  Patients with DLCO < 60% or Diffusing Lung Capacity of carbon monoxide attesting a
 severe pulmonary insufficiency.

 -  Patients with peripheral blast cell count over 10%.

 -  Second neoplasia diagnosed no more than 2 years before.

 -  Patients with active or suspected infection by fungi for which a therapeutic treatment
 is ongoing.

 -  HIV positive patients.

 -  HCV-RNA and HBV-DNA positive patients

 -  Pregnant or lactating women.

 -  Severe mental diseases.