The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.
Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
ex-vivo expansion of cord blood for transplantation
Safety
Number of patients with adverse events during infusion
Time frame: 1 month
engraftment
Time to engraftment
Time frame: 3 months
treatment-related toxicity
Type and severity of adverse events after transplantation using the NCI CTC scale
Time frame: 3 months
GVHD
Number of patients with acute and chronic GVHD after transplantation
Time frame: 1 year
Immunological reconstruction
immunological reconstruction after transplantation measured by lymphocyte number and function
Time frame: 5 years
relapse
rate of disease recurrence
Time frame: 5 years
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