VALIDATION OF PLASMA REDUCTION IN HEMATOPOIETIC PROGENITOR CELLS FOR CRYOPRESERVATION: IMPACT ON CELL RECOVERY AND PRODUCT SAFETY

@article{calheiros2026validation,
  title = {{VALIDATION OF PLASMA REDUCTION IN HEMATOPOIETIC PROGENITOR CELLS FOR CRYOPRESERVATION: IMPACT ON CELL RECOVERY AND PRODUCT SAFETY}},
  author = {Waldely Veneziani CALHEIROS and Miria Lemos DA SILVA and Nayanna Faria DE CARVALHO and Erica Mioto Braz MERCHAN and Mirianceli Coelho MENDONÇA and Cesar De Almeida NETO},
  journal = {Hematology, Transfusion and Cell Therapy},
  year = {2026},
  month = oct,
  doi = {10.1016/j.htct.2026.106923},
  url = {https://doi.org/10.1016/j.htct.2026.106923},
  note = {CC BY},
}

TY  - JOUR
TI  - VALIDATION OF PLASMA REDUCTION IN HEMATOPOIETIC PROGENITOR CELLS FOR CRYOPRESERVATION: IMPACT ON CELL RECOVERY AND PRODUCT SAFETY
AU  - Waldely Veneziani CALHEIROS
AU  - Miria Lemos DA SILVA
AU  - Nayanna Faria DE CARVALHO
AU  - Erica Mioto Braz MERCHAN
AU  - Mirianceli Coelho MENDONÇA
AU  - Cesar De Almeida NETO
PY  - 2026
DA  - 2026/10/23
JO  - Hematology, Transfusion and Cell Therapy
DO  - 10.1016/j.htct.2026.106923
UR  - https://doi.org/10.1016/j.htct.2026.106923
AB  - Introduction: Hematopoietic progenitor cell (HPC) transplantation often requires cryopreservation of the cellular product until the time of infusion. Dimethyl sulfoxide (DMSO) is widely used as a cryoprotective agent; however, its toxicity may pose risks, particularly in pediatric patients. Plasma reduction strategies prior to cryopreservation have been adopted to decrease the final product volume and the amount of infused DMSO while maintaining cellular quality and transfusional safety. This study aimed to validate a plasma reduction process for HPC products intended for cryopreservation in a cellular therapy service. Methods: This concurrent validation study was conducted at the Cell Processing Center Laboratory between May and December 2025. A total of 41 HPC samples were evaluated, including 34 peripheral blood HPC products (PB-HPC) and seven bone marrow HPC products (BM-HPC). The protocol was based on a previously validated procedure from a partner institution and adapted to the institutional routine. Samples were evaluated at three stages: baseline, pre-procedure, and post-procedure. Parameters analyzed included volume, hematocrit, leukocyte count/µL, leukocytes × 10⁸/mL, leukocytes × 10⁸/bag, leukocytes × 10⁸/kg recipient, and percentage of cell recovery. The predefined acceptance criterion was ≥ 80% recovery in at least 90% of the analyzed samples. Results: The mean cell recovery rate was 92.8%. Among the 41 evaluated samples, 97.6% achieved recovery ≥ 80%, meeting the predefined acceptance criteria. Only one sample showed recovery below the established threshold (69%). This sample corresponded to a BM-HPC product intended for a 6.9 kg pediatric patient. In this case, a more extensive plasma reduction was performed to achieve a final infusion volume considered safe, as requested by the attending medical team. Despite the lower recovery rate, the final cell count remained within clinically acceptable parameters for transplantation and was therefore considered a planned deviation. All patients who received processed products during the validation period were monitored by both the cellular therapy service team and the attending physicians, and no adverse events related to product quality or safety were observed. Conclusion: The plasma reduction protocol for HPC cryopreservation proved to be safe, reproducible, and effective, demonstrating a high cell recovery rate and compliance with the predefined validation criteria. This strategy enabled volume reduction and potentially decreased DMSO exposure, which is particularly relevant for pediatric patients, without significant impairment of cellular quality. These findings support the definitive implementation of the protocol into the routine practice of the transfusion medicine service.
SN  - 2531-1379
SN  - 2531-1387
ER  -