Quality controls of cryopreserved haematopoietic progenitor cells (peripheral blood, cord blood, bone marrow)

Post‐thaw viability of cryopreserved peripheral blood stem cells (PBSC) does not guarantee functional activity: important implications for quality assurance of stem cell transplant programmes

“…The processes governing transplant programmes are closely regulatedsuch as by JACIE accreditation and, in the UK, the Human Tissue Authority. The details of QC procedures for products varies significantly between countries and between laboratories in the same country (Rosskopf et al, 2011). The details of QC procedures for products varies significantly between countries and between laboratories in the same country (Rosskopf et al, 2011).…”

“…Nevertheless, cell processing and cryopreservation procedures have been devised empirically by many individual centres prior to the regulatory era and are poorly standardized with the notable exception of standardized flow cytometric CD34 + cell counts (Barnett et al, 1998;Gratama et al, 2003). The details of QC procedures for products varies significantly between countries and between laboratories in the same country (Rosskopf et al, 2011). Although historically CFU-GM assays were used, based on previously available evidence and the real-time and convenient nature of viability assays, the majority of laboratories have moved to using quantification of CD34 + cells and confirmation of post-thaw viability for routine QC.…”

Comparison of the cryoprotective solutions based on human albumin vs. autologous plasma: its effect on cell recovery, clonogenic potential of peripheral blood hematopoietic progenitor cells and engraftment after autologous transplantation

“…Nevertheless, there have been no uniform standards so far concerning composition of cryoprotective media and cryopreservation procedures . Many factors related to cryopreservation process of harvested PBPCs can affect their post‐thaw quality.…”

“…Many factors related to cryopreservation process of harvested PBPCs can affect their post‐thaw quality. Cell storage conditions before and after cryopreservation (liquid nitrogen vapour or mechanical freezer), concentration, cryoprotectants, freezing procedure, all have to be taken into account to ensure adequate quality of cryopreserved PBPCs including also HSCs from other sources like umbilical cord blood (UCB) or bone marrow (BM) .…”

A new system for quality control in hematopoietic progenitor cell units before reinfusion in autologous transplant

“…Before hematopoietic SCT, it is recommended that accurate quality controls (QCs) be performed using the bag's satellite cryovials to assess the median number of viable CD45+/7‐aminoactinomycin (7‐AAD)– and CD45+/CD34+/7‐AAD– cells, the presence of microbiologic contamination, and the proliferative potential of hematopoietic progenitor cells . The guidelines for the determination of the QCs have been established by FACT/JACIE and NetCord/FACT standards …”