Safety and efficacy of hematopoietic stem cell collection from mobilized peripheral blood in unrelated volunteers: 12 years of single-center experience in 3928 donors

Abstract

We present results of peripheral blood stem cell (PBSC) mobilization, collection, and follow-up from 3928 consecutive unrelated stem cell donors. Assessments were performed prospectively at baseline, leukapheresis, 1 month, 6 months, and annually after PBSC donation. During follow-up, side effects were recorded by return post questionnaires. The median CD34 ؉ cell counts on day 5 were 67.5/L in male and 51/L in female donors. Bone pain and headache were the most common side effects of recombinant human granulocyte-colony stimulating factor. Central venous access was required for 23 donations (0.6%). Throughout the follow-up, the absolute neutrophil counts were slightly below the initial baseline values but remained within the normal range. The majority of the donors reported good or very good health. Malignancies occurred in 12 donors (0.3%), among whom were 1 case of acute myeloid leukemia, 1 case of chronic lymphatic leukemia, and 2 cases of Hodgkin disease. Only the incidence of Hodgkin lymphoma differed significantly from an age-adjusted population. In conclusion, 7.5 g/kg per day lenograstim proved to be safe and effective for mobilizing hematopoietic stem cells for allogeneic transplantation. Long-term monitoring of healthy PBSC donors remains important to guarantee the safety standards of PBSC mobilization and collection.

Uniform examination of stem cell donors

“…Long-term increased risks of PBSC donation have not been identified [36,37], but remain of concern, in particular development of haematological malignancy, solid tumours, myelodysplasia, vascular and autoimmune diseases. In the retrospective EBMT study, a follow-up questionnaire revealed that 20 out of 51 000 donors had developed a haematological malignancy between 4 months and 12 years post-donation (15 related donors and 5 not reported) [30].…”

“…In the retrospective EBMT study, a follow-up questionnaire revealed that 20 out of 51 000 donors had developed a haematological malignancy between 4 months and 12 years post-donation (15 related donors and 5 not reported) [30]. The large unrelated donor registries now collect long-term outcome data of donors in a systematic prospective manner [33][34][35][36][37].…”

Allogeneic hematopoietic stem cell donation—standardized assessment of donor outcome data: A consensus statement from the Worldwide Network for Blood and Marrow Transplantation (WBMT)

“…[16][17][18][19] Current experience suggests that risks seem to be higher for related than for unrelated donors with the caveat of reporting bias and lack of an adequate amount of prospective follow-up data in the related donor setting. [9][10][11]18 These rare SAE/R that occur with estimates of about 1 in 3-5000 for serious and 1 in 10-20 000 for lethal events are still incompletely understood. [9][10][11][16][17][18][19] Hence, there is urgent need for better understanding of short-term SAR and to identify donors at risk.…”

“…[9][10][11]18 These rare SAE/R that occur with estimates of about 1 in 3-5000 for serious and 1 in 10-20 000 for lethal events are still incompletely understood. [9][10][11][16][17][18][19] Hence, there is urgent need for better understanding of short-term SAR and to identify donors at risk. Because of the rarity of the events, progress can only be achieved by large international collaborations that include both unrelated and related donors.…”

“…Today, large registry studies in unrelated donors [9][10][11] form the basis for the current knowledge on the frequent side effects during BM and PBSC donation, which are usually of mild or moderate severity. Smaller studies from related donors suggest that these frequent side effects occur with the same pattern in related donors.…”