PBSC collection from family donors in Japan: a prospective survey
Insights
Severe adverse events (SAEs) after peripheral blood stem cell (PBSC) donation are infrequent. Risk factors for acute SAEs were identified, but late hematological malignancy risks did not differ significantly from bone marrow donors.
Area of Science:
- Hematology
- Transplantation Medicine
- Public Health
Background:
- Severe adverse events (SAEs) and late hematological malignancies are potential risks following peripheral blood stem cell (PBSC) donation.
- Prospective data on incidence and risk factors for family donors were lacking.
Purpose of the Study:
- To prospectively evaluate the incidence and risk factors of acute and late SAEs in PBSC donors.
- To compare the incidence of late hematological malignancies in PBSC donors with bone marrow (BM) donors.
Main Methods:
- Implementation of a mandatory registration system by the Japan Society for Hematopoietic Cell Transplantation (JSHCT) in 2000.
- Standardized donor eligibility criteria and immediate SAE reporting.
- Follow-up examinations at day 30 and annual contact for 5 years.
Main Results:
- Acute SAEs occurred in 1.44% of donations (0.58% unexpected and severe); no deaths within 30 days.
- Late SAEs were reported in 2.3% of donors.
- Higher incidence of acute SAEs in donors not meeting JSHCT standards (P=0.0023).
- No significant difference in late hematological malignancies between PBSC and BM donors (1/1708 vs 2/5921; P=0.53).
Conclusions:
- Acute and late SAEs occur at a relatively low frequency in PBSC donors.
- Identifiable risk factors exist for acute SAEs.
- PBSC donation does not appear to increase the risk of late hematological malignancies compared to BM donation.
Abstract:
Severe adverse events (SAE) and late hematological malignancies have been reported after PBSC donation. No prospective data on incidence and risk factors have been available for family donors so far. The Japan Society for Hematopoietic Cell Transplantation (JSHCT) introduced therefore in 2000 a mandatory registration system. It defined standards for donor eligibility and asked harvest centers to report any SAE immediately. All donors were examined at day 30 and were to be contacted once each year for a period of 5 years. Acute SAEs within day 30 were reported from 47/3264 donations (1.44%) with 14 events considered as unexpected and severe (0.58%). No donor died within 30 days. Late SAEs were reported from 39/1708 donors (2.3%). The incidence of acute SAEs was significantly higher among donors not matching the JSHCT standards (P=0.0023). Late hematological malignancies in PBSC donors were not different compared with a retrospective cohort of BM donors (N:1/1708 vs N:2/5921; P=0.53). In conclusion, acute and late SAEs do occur in PBSC donors at relatively low frequency but risk factors can be defined.
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