Safety and Risk of Allogeneic Peripheral Blood Stem Cell Donation: The Comprehensive Report of Nation-Wide Consecutively Pre-Registered 3,264 Family Donor Survey In 10years Project by Japan Society for Hematopoietic Cell Transplantation.
Authors: Kodera Yoshihisa , Yamamoto Kazuhito , Kato Shunichi , Harada Mine , Kanda Yoshinobu , Hamajima Nobuyuki , Asano Shigetaka , Ikeda Yasuo , Imamura Masahiro , Kawa Keisei , Morishima Yasuo , Nakahata Tatsutoshi , Tanimoto Mitsune , Dohy Hiroo , Tanosaki Ryuji , Shiobara Shintaro , Kim Sung-Won , Nagafuji Koji , Hino Masayuki , Miyamura Koichi , Suzuki Ritsuro 
Published: October 2019

Abstract
Abstract 1180

Background:
Although peripheral blood stem cell (PBSC) donation has been considered safe and less stressful, certain fetal or life-threatening acute (within 30 days of post donation) adverse events as well as late occurrence of hematological malignancies have been reported among donors. Since the Japan Marrow Donor Program requires the confirmation of safety and risk of PBSC donation at family donors prior to applying this technique for volunteer donors, the Japan Society for Hematopoietic Cell Transplantation (JSHCT) performed nation-wide consecutive pre-registration and follow up for PBSC family donors from 2000 to 2010. This time, we report the comprehensive outcome of this project.

Methods:
The JSHCT mandated the registration of every PBSC family donor at the donor registration center then, issued donor identification number to each donor. The society required every harvest center to observe the JSHCT standards for donor eligibility, stem cell mobilization and harvest. The society also required to notify it of any severe adverse events, the results of the day30 clinical and laboratory check and of the annual health check for five years.

Findings:
Among 3,264 pre-registered donors, 47 emergency reports were submitted for 5 years and it was revealed that acute unexpectedly severe adverse events such as interstitial pneumonitis or anginal attack occurred at 0.58 % of donors although no mortality cases within 30 days of post donation were found. The relationship between donors' basic information such as age or gender and clinical and laboratory abnormalities obtained from 2,882 day 30 reports was studied and it revealed the followings; the risk factor for fatigue, headache, insomunia, anorexia and nausea was female, the risk factors for prolongation of hospitalized period were older age, low body weight, high total dose of granulocyte colony stimulating factor (G-CSF), the presence of past or current health problems and the episode of past stem cell donation, the risk factors for thrombocytopenia were older age and high total dose of G-CSF, the risk factors for splenomegary were older age and high total dose of G-CSF, the risk factors for poor CD34+ cell mobilization were older age, female and the episode of past stem cell donation, the risk factor for over CD34+ stem cell mobilization was younger age. The information from 6,233 annual health checks from 1,708 donors for 5 years showed the followings; the incidence of non-malignant but significant health problems was 1.5%, the incidence of non hematological malignancies was 0.7%, the incidence of hematological malignancy was 0.06%. It was also confirmed that the incidence of hematological malignancies among PBSC donors was not high compared with that among retrospectively surveyed bone marrow family donors.

Interpretation:
The consecutive donor pre-registration and annual follow up system that sets strict standards for donor eligibility, cell mobilization and harvest is effective in preventing real life-threatening acute adverse events and also is useful to know the real figures on PBSC donors and to assure donor safety. Such a system should be applied to all hematopoietic stem cell (family and volunteer, bone marrow and peripheral blood) donors.

Disclosures:
No relevant conflicts of interest to declare.