Intra-bone Cord Blood Transplantation

Hematologic Neoplasms Clinical Trial

Official title: Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hematologic Neoplasms

• NCT number: NCT01332006
• Study type: Interventional
• Source: Università degli Studi di Brescia
• Contact: Prof Domenico Russo, Full Professor
• Phone: +39/030/3996812
• Email: russo@med.unibs.it
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2009
• Completion date: December 2019