Cell selection is an important part of graft manipulation for cellular therapies. The CliniMACS Plus system has been used in our laboratory for over 15 years to deplete T-cells from stem cell grafts of the unrelated donors for paediatric patients undergoing BMT. The recently introduced CliniMACS Prodigy® (Miltenyi Biotec) permits automated selection of CD34+ cells from mobilized peripheral blood stem cells (PBSCs) using monoclonal antibodies conjugated to paramagnetic particles in a complete closed system. We have been evaluating the Prodigy and we report the most extensive evaluation, to date, between the Prodigy and the CliniMACS Plus systems.

METHODS:

We validated the CD34 selection program on the Prodigy (LP-34, using the new version 2.0) against the standard semi-automatic CD34 selection process on the CliniMACS Plus. PBSCs were collected by apheresis from nine healthy adult subjects after mobilisation with G-CSF. Excess PBSCs were loaded onto the Prodigy the day after the clinical procedure. Target and non-target cells were enumerated using standard viable single platform flow cytometry. The nine Prodigy procedures were assessed for product quality against historical CliniMACS Plus data. Samples used for the Prodigy validation (not clinically infused), were only used when the requested CD34 dose had been achieved using the CliniMACS Plus.

RESULTS (see Table 1):

All nine Prodigy procedures were completed without event. Although there was no difference in procedure times between the two machines, there was a reduction in "hands on" time using the CliniMACS Prodigy. Eight of the nine PBSCs were collected from overseas and loaded onto the Prodigy the day after the clinical processing. The age of products loaded onto the instrument ranged from 21 to 139 hours, median 41 hours. Despite the age of the product there was no clumping observed.

CONCLUSIONS:

CD34+ cells can be effectively selected from mobilized PBSCs with the CliniMACs Prodigy, including those that have had prolonged transit times. The recovery and purity of CD34+ cells was comparable to the CliniMACS Plus but depletion of T and B-cells was found to be lower on the Prodigy compared to the CliniMACS Plus. The T cell and B cell content per kg, from the Prodigy, was below 10x10^4/kg, the upper limit for clinical release criteria. The Prodigy offers a single device for CD34 cell selection, unlike the CliniMACS Plus which required the apheresis product to have prior processing (such as platelet removal, labelling and washing prior to cells etc.) on other equipment. The Prodigy process is fully automated and this translates into a reduction in the time required of experienced laboratory staff. Our results suggest that the Prodigy can be used for the routine clinical application of CD34 selection to HSCT products. Analysis of other complex cell manipulations using the CliniMACS Prodigy will require further validation.

Table 1
Table 1.
View largeDownload slide
Disclosures

Gottlieb: Abbvie: Membership on an entity's Board of Directors or advisory committees; Indee: Membership on an entity's Board of Directors or advisory committees.

Topics:
cd34 antigens, peripheral blood stem cells, apheresis, tissue transplants, cell therapy, flow cytometry, granulocyte colony-stimulating factor, hematopoietic stem cell transplantation, medical devices, monoclonal antibodies

Author notes

*

Asterisk with author names denotes non-ASH members.

© 2017 by The American Society of Hematology
2017
Sign in via your Institution