A survey of cell processing practices for hematopoietic cell transplantation

Area of Science:

• Hematology
• Cellular Therapy
• Transplantation Medicine

Background:

• Significant heterogeneity exists in cell handling practices within Spanish cell processing centers for hematopoietic stem cell transplantation (HSCT).
• Current European and international standards do not dictate specific best practices, necessitating individual laboratory protocol development.
• This variability impacts the consistency and quality of HSCT procedures.

Purpose of the Study:

• To investigate and identify variations in cell processing laboratory practices across Spain.
• To pinpoint areas requiring harmonization in HSCT procedures.
• To understand differences in facilities, services, staff, quality control, and logistics.

Main Methods:

• A survey was distributed to authorized cell processing laboratories in Spain.
• The survey assessed diverse aspects including facilities, equipment, services, staff, informatics, product handling, quality control, release criteria, storage, shipping, and disposal.
• Data from 31 responding centers were analyzed to identify practice variations.

Main Results:

• Washing of cryopreserved grafts varied, with 15 centers not routinely washing, 5 washing systematically, and 11 washing under specific conditions (high DMSO or low recipient weight).
• Substantial variability was observed in thawed sample handling, including CD34+ cell enumeration protocols, compensation solutions, and temperature/time delays.
• Product storage durations ranged widely (5-30 years), and 12 centers did not reduce plasma pre-cryopreservation to conserve space.

Conclusions:

• The survey highlights considerable variability in operations, logistics, and staffing among Spanish HSCT processing laboratories.
• Further harmonization efforts are needed for critical procedures like cryopreserved stem cell washing and post-thaw CD34+ cell enumeration.
• Standardizing product storage is essential for optimizing space utilization and reducing costs.