Bone Marrow Collection with the BioAccess system– a field report

According to DKMS Donor Center gGmbH, bone marrow collection (BMC) for leukaemia and other hemoglobinopathies is still done in ~10% of the cases. As the collection set of Fresenius Kabi AG Germany wasn`t available anymore, it was necessary to establish an alternative. We started collecting stem cells with the system of BioAccess Inc., USA (temporary licensed by BfARM) as from September 2022. This study was done to verify the suitability of the set concerning handling and for validation purpose.

Bone marrow collection was done with the BioAccess Marrow Collection System (BioAccess Inc., USA; MH-2150) by an accompanying risk based validation (n=11). Volume was calculated by weighing the collection bag and compared to the bag´s scaling. This is important for the operator during bone marrow collection. Quality parameter as hematocrit (hct), dose of nucleated cells (NC) with cell viability, visual inspection and microbiological contamination of the cell suspension were analyzed. Additionally, microbiological contamination due to luer-lock connections and a potential cell loss by filtration were considered. Data are presented as median values.

The collected volume was 1378 mL. One product didn`t meet the specification of ≤ 1650 mL without any critical consequence for donor and patient. Comparing weight to scaling, there is a deviation below 1000 mL of up to 100 mL, whereas at higher volumes weight and scaling accord to each other. Due to weight of patient and donor 1.75 x 108 NC/kg body weight (1.3-4.92 x108) were collected. Dose of 0.10 x108 NC, 100% viability and hct of 29.9% met the specifications of ≤ 3 x 108 NC, ≥ 80% viability and hct ≤ 60%, respectively. There was no microbiological contamination. One BMC showed coagulation despite second filtration and extra anticoagulant. Set integrity was given in all cases. Cell loss due to filtration was 0% (n=10) and 13% (n=1).

The operators attested an easy handling of BioAccess Marrow Collection System and the analytical data fulfilled our specifications. Deviations were based on medical decisions or donation phenomena. As there is only one set of filters included, a completely new collection set has to be opened when filter blockage makes it necessary. The BioAccess Marrow Collection System is an adequate alternative for the former collecting set of Fresenius Kabi.

There is no conflict of interests.