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Washing of apheresis or bone marrow hematopoietic cells

BT515

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Clinical information

Clinical utility

Although infusion of hematopoietic progenitor cells (HPCs) containing dimethyl sulfoxide (DMSO) is generally well tolerated, in some cases, such as paediatric patients, washing of the thawed product to remove DMSO or cellular detritus is indicated.

In cases of a history of anaphylactic reactions to blood components or a high number of cryopreserved red blood cells in the case of bone marrow, it is also indicated to wash the product to remove the maximum plasma content.

Method

The washing service carried out by the Cell Therapy Service (Cell Therapy Laboratory) is automated and performed in a closed system. This system reduces the time and risk of contamination.

The process consists of adding a wash solution (saline, anticoagulant and albumin), centrifugation and removal of the supernatant. The next step is resuspension of this wash solution.

Reference values

The loss of cellularity from the wash process is between 10 and 30%.

Specimen information

Product: Apheresis or washed BM HPC.

Tube: not applicable.

Volume: less than 200 ml.

Shelf life: 4 hours.

Transport instructions: 2-8 °C.

Storage instructions: 2-8 °C.

Administrative information

BST code: BT515.

Description of the test: when recipients may have toxicity due to the cryoprotectant (DMSO) or the granulocyte content or elevated red blood cell count, the prescribing physician may request a washout of DMSO prior to infusion.

Synonyms: HPC-W.

Section: Cell Therapy Service. Cell Therapy Laboratory.

Service: this fee (BT515) includes the DMSO wash and the quality controls associated with this processing. The washout is a complex process and is carried out in the Cell Therapy Laboratory in the Dr Frederic Duran i Jordà building in Barcelona. Therefore, this fee will be combined with the fresh provision fee (PRG035), since it is necessary to control the quality of the reconstituted product and to transport it urgently to the clinical unit.

References

Areman, E. M.; Loper, K., editors. Cellular therapy: Principles, methods, and regulations. 2nd ed. Bethesda (MD): AABB Press, 2016.

Quality

The BST has ISO 9001, ISO 14001, OSHAS 18001 and European Seal of Excellence 500+ quality certifications. The BST is accredited by CAT, JACIE-FACT, FACT-NETCORD and EFI. It complies with the guidelines of good manufacturing and good distribution practices.

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