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.
|Hematologic Neoplasms||Procedure: Intrabone injection Biological: Intra-bone cord blood hematopoietic stem cell transplantation||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor|
- Proportion of transplanted patients with successful engraftment at day +30 [ Time Frame: 30 days post transplantation ]Engraftment
- Clinical response with the analysis of global survival, survival without relapse, relapse incidence [ Time Frame: 3 years from transplantation ]
- Infections' Incidence [ Time Frame: One year after transplantation ]
- Chimerism monitoring on selected cell populations [ Time Frame: Every three months and until one year after transplantation ]
- Immunological reconstitution [ Time Frame: One year after transplantation ]
- Acute an Chronic GVHD [ Time Frame: One year after transplantation ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Intra-bone injection
Intra-bone transplantation of hematopoietic stem cells from cord blood
Procedure: Intrabone injection
All adults patients with hematological malignancies, lacking a HLA matched donor fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB.
Other Name: Intrabone TransplantBiological: Intra-bone cord blood hematopoietic stem cell transplantation Biological: Intra-bone cord blood hematopoietic stem cell transplantation
Intra-bone injection of CB hematopoietic SCs after conditioning regimen
Other Name: No other name
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332006
|Contact: Prof Domenico Russo, Full Professorfirstname.lastname@example.org|
|USD TMO Adulti, Piazzale Spedali Civili||Recruiting|
|Brescia, Italy, 25100|
|Contact: Michele Malagola, Medical Doctor +39/030/3996811 email@example.com|
|Principal Investigator:||Domenico Russo, Full Professor||USD TMO Adulti|