Trial | NCT01332006  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    17
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.
Study Started
Nov 30
2009
Primary Completion
Dec 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Nov 13
2018

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 names: Intrabone Transplant

Biological 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 names: No other name

Intra-bone injection Experimental

Intra-bone transplantation of hematopoietic stem cells from cord blood

Criteria 

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.
No Results Posted