Gelofusine as alternative to Dextran40-based solution for washing cryopreserved hematopoietic stem cell products prior to infusion: Validation and application to clinical practice.

Background: Cryopreservation is an essential step for autologous hematopoietic stem cell (HSC) transplantation and umbilical cord blood units (CBUs), and for allogeneic peripheral blood stem cells (PBSCs) or bone marrow (BM) when immediate infusion is not possible. However, the cryoprotectant dimethyl sulfoxide (DMSO) used for HSC cryopreservation can be toxic to cells post-thaw and to patients during infusion. The Rubinstein solution is validated to wash HSCs, but the unavailability of Dextran40 in Italy prompted a search for alternatives. This report discusses the use of Gelofusine, a 4% modified gelatin solution, as a substitute for Dextran40-based solutions in washing cryopreserved stem cell products.

Study Design And Methods: The study includes: (1) validation of Gelofusine in 10 CBUs unsuitable for transplantation; (2) outcomes of the first 93 transplanted units washed with Gelofusine; (3) comparisons of recovery and viability in five paired autologous PBSC products washed with Gelofusine and Rubinstein-solution; and (4) comparisons of engraftment times in patients receiving units washed with Gelofusine and Rubinstein-solution.

Results And Discussion: For 10 CBUs washed with Gelofusine, CD34 and TNC viability and recovery were 96%, 87%, 71%, and 75% respectively, higher than our reference values. In transplanted products, CD34 and TNC viability and recovery were 96%, 89%, 82%, and 91% respectively. Comparisons with Rubinstein solution revealed similar TNC and CD34 recovery but significantly higher TNC (89% vs. 68%) and CD34 (97% vs. 89%) viability with Gelofusine. Engraftment times for both solutions were similar. These findings support Gelofusine as an effective and valid alternative to Rubinstein-solution for washing cryopreserved HSCs.