| Abstrakt: |
Background aims. We investigated two different plastic freezing bags, namely the most recently U.S. Food and Drug Administration (FDA)-approved CryoMACS®® freezing bag (200-074-402) from Miltenyi Biotec and the familiar Cryocyte®® freezing bag (R4R9955) from (Baxter Healthcare, Deerfield, IL, United States) for the cryogenic storage of human hematopoietic progenitor cells (HPC). Methods. The study material consisted of 12 frozen HPC pairs (== 24 transplant units) that were no longer needed for autologous treatment of patients. After thawing, one unit of a pair was transferred into the Miltenyi (M) bag; the other unit remained in the original Baxter (B) bag. After refreezing both units, all units were stored again under cryogenic conditions either partially immersed in liquid nitrogen ( n == 22) or in the vapor phase over liquid nitrogen, n == 2, <−−170°°) before thawing. Results. The correlation coefficients ( r) between the results obtained from the two bag types were high for white blood cells (WBC) content ( r == 0.98), mononuclear cells (MNC) ( r == 0.97), lymphocytes ( r == 0.98), monocytes ( r == 0.96), membrane integrity ( r == 0.93), concentration of ''free'' hemoglobin ( r == 0.97) and hemolysis rate ( r == 0.95). With regard to clonogenicity, there were no significant differences (Student's paired t-test) for the three parameters investigated [i.e. total number of colonies, including the numbers of burst-forming units--erythroid (BFU-E) and colony-forming units--granulocyte-macrophage (CFU-GM) colonies, respectively). Conclusions. The CryoMACS freezing bag 200-074-402 is bioequivalent to the Cryocyte freezing container R4R9955. An advantageous feature of the CryoMACS is that its double-sterile wrapping provides additional safety regarding potential cross-contamination during cryogenic storage. [ABSTRACT FROM AUTHOR] |
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