In 2022, we conducted a survey to assess how institutions were handling regenerative medical products. The survey was distributed to 203 facilities, including university hospitals, national and public hospitals, Japan Marrow Donor Program-certified hospitals, children's hospitals, and perinatal medical centers. A total of 140 facilities responded. The current status of in-hospital adoption of regenerative medical products is as follows: among 11 types of human cell/tissue products, Temcell^® HS had the high usage rate of 80.7%, while Kymriah^® (Tisagenlecleucel) had a usage rate of 28.6%. Of the three types of gene therapy product, Zolgensma^® (Onasemnogene abeparvovec-xioi) had the highest usage rate at 18.6%. Regarding transfusion departments, while these were involved in the apheresis and management of regenerative medical products, they had was no involvement with Nepic^® or Ocural^®. It should be noted that these products are specified as designated-regenerative medical products, and the storage of administration records within the institution is therefore mandated, similarly as for blood products. Some of these products involve the participation of specialized departments, but the majority were under management of the respective medical department and pharmacy division. This survey highlighted challenges in the management and handling of regenerative medical products within the hospital from the perspective of the transfusion department.

During platelet and plasmapheresis, a significant amount of blood is lost through the initial test blood collection and the residual blood that remains in the disposable plastic sets.

To address this issue, we examined ferritin levels in 523 blood donors who had not donated whole blood within the previous year. We compared ferritin levels between two groups: those who used only machines with low residual blood (group C) and those with high residual blood (group T).

The study revealed that ferritin levels were less than 12 ng/ml in 33.3% of male donors and 61.1% of female donors who donated 13 to 24 times within the previous year. As donation frequency increased among male donors, the mean ferritin level decreased. However, there was no significant difference in ferritin levels between group C and T among those with 12 or fewer annual donations. Our findings suggest that an elevated number of lifetime blood donations also impacted iron deficiency.

These findings emphasize the importance of regularly monitoring donors' ferritin levels, iron supplementation, reducing donation frequency, and adopting the saline reinfusion procedure to prevent iron depletion.

A 65-year-old male patient was admitted to the Jikei Daisan Hospital due to leukocytosis, anemia, and thrombocytopenia. He was diagnosed as having Philadelphia-positive acute myeloid leukemia. He was negative for hepatitis B surface antigen (HBsAg), HBs antibody, and HB core antibody before transfusion. On day 3 of hospitalization, he was transfused with platelets. The transfusion product was confirmed negative on the quadrivalent nucleic acid amplification test (NAT), conducted as pre-transfusion screening. The donor was positive for NAT two weeks later at the time of re-donation, but retrospective survey was not done due to a negative result for additional hepatitis B virus (HBV) DNA. However, the donor was found positive for HBVDNA one month after re-donation. Case review revealed that the patient had received the product, which had been collected during the window period. Monitoring for both HBsAg and HBVDNA every three to six weeks was required. Although HBVDNA was negative on day 44, 84, and 129 after hospitalization, he became positive for HBsAg and HBVDNA six months after transfusion, on day 149. HBVDNA sequence between the patient and donor were matched, confirming post-transfusion HBV infection. Preemptive therapy with entecavir prevented the development of acute hepatitis, and his HBVDNA status became negative.

A 69-year-old woman treated for Evans syndrome underwent direct antiglobulin test (DAT) -positive autologous blood transfusion perioperatively during hip replacement surgery. Hemolytic findings of the stored erythrocyte products did not differ over time from those of the components of erythrocyte products supplied by the Japanese Red Cross Society. DAT intensity of the first stored autologous erythrocytes remained unchanged for 35 days, while dissociated fluid antibody titer decreased 16-fold up to Day 21 and 8-fold after Day 28. The DAT intensity of autologous erythrocytes in the second blood reservoir remained unchanged for 14 days, and the antibody titer of the dissociated fluid showed a 4-fold decrease. Clinical course following administration of 4 units of DAT-positive autologous red blood cells and 2 units of autologous fresh-frozen plasma up to 48 hours postoperatively was satisfactory, without evidence of hemolysis. Few studies have reported the effectiveness of stored autologous blood transfusion in DAT-positive patients, and many points are unclear. Here, we experienced a case in which an effective transfusion effect was obtained by performing appropriate preliminary evaluation and product monitoring.