Severe Adverse Events of Allogeneic Related Peripheral Blood Stem Cell Donors -Results of Nation-Wide 3,262 Consecutively and Prospectively Registered Case-Survey in Japan and of Its Comparison to the Outcome of Retrospective Survey Shared with EBMT for Stem Cell Donors.
Authors: Kodera Yoshihisa , Kato Shunichi , Harada Mine , Shiobara Shintaro , Hamajima Nobuyuki , Morishima Yasuo , Tanimoto Mitsune , Asano Shigetaka , Ikeda Yasuo , Dohi Hiroo , Nakahata Tatsutoshi , Imamura Masahiro , Kawa Keisei , Takaue Yoichi , Kanda Yoshinobu , Yamamoto Kazuhito , Favre Genevieve , Gratwohl Alois 
Published: April 2020

Abstract
In April 2000, we created a system, which was cooperatively steered by The Japan Society for Hematopoietic Cell Transplantation (JSHCT) and G-CSF producing and/or selling companies, to catch up the types and the frequencies of acute and late severe adverse events (SAE) of peripheral blood stem cell (PBSC) donors among relatives in Japan. Every PBSC donor was registered to JSHCT and was given unique donor number before the PBSC donation. Every harvest center was mandatory required to observe the JSHCT Guideline for donor’s criteria and to submit the day 30 report as well as the immediate report of any severe SAE, and also to ask donors’ receiving annual health check for 5 years. This time, we report the acute SAE observed among 3,262 consecutive donors in 233 institutes and the late SAE reported through annual health check by the forth year of post PBSC harvest among 1,370 donors (2,849 times) who agreed with this work of the society. As of March 2005, 50 acute SAE out of 3,262 cases (1.5%) were reported, including anginal attack, vain thrombosis, retroperitoneal hematoma, subarachnoid hemorrhage, interstitial pneumonitis and others. Twenty-eight (2.0%) of late SAE were reported from 1,370 cases, including 1 hematological malignancy (acute myelogenous leukemia ), 8 other malignancies and others. To compare these acute and late SAE of PBSC donors to those of bone marrow (BM) donors, the questionnaires, a part of which was shared with The European Group of Blood and Marrow Transplantation (EBMT) were sent to 286 institutes of JSHCT and 191 institutes (67%) answered about 5,921 cases of bone marrow harvest from relatives and the comparative results were as followings: PBSC donors: BM donors, per 10,000; Death within 30 days = 0:1.7, SAE within 30days of post-harvest=153.0:35.5 (Definite SAE=21.5:6.8), Hematological malignancy at anytime of post donation = 3.1:2.9. On the other hand, the results obtained by EBMT, where the both surveys were retrospective, were as followings (PBSC donors: BM donors, per 10,000 ); Death within 30 days = 1.83:0.22, SAE within 30 days = 9.7:2.7, Hematological malignancy at anytime of post-donation =3.0:2.0. These results showed the followings; 1) the acute SAE might occur more frequently at PBSC donors, 2) the different frequency of acute SAE and of the mortality within 30 days of post-donation at PBSC donors between JSHCT side and EBMT side might reflect the difference of donor survey system; pre-registration with guideline for donor’s eligibility vs. retrospective survey, 3) the frequency of the occurrence of hematological malignancy was not necessarily high at PBSC donors. Although the case numbers studied at PBSC donors and BM donors in JSHCT and EBMT were different each other, no death within 30days was reported among PBSC donors of JSHCT so far and it might come from the pre-registration system of donors which made the surveillance for the safety of every donor possible and is recommended for both PBSC and BM donors at an international level in order to improve donor safety.