Allogeneic transplantation of cytokine-mobilized peripheral blood stem
cells (PBSCs) is now being increasingly performed, but safety conside
rations for hematologically normal PBSC donors have not been fully add
ressed. Progenitors are generally mobilized for collection from normal
donors using recombinant human granulocyte colony-stimulating factor
(rhG-CSF). Although the short-term safety profile of rhG-CSF seems acc
eptable, experience remains limited and its optimal dose and schedule
have not been defined. Minimal data exist regarding long-term safety o
f rhG-CSF, primarily derived from experience in patients with chronic
neutropenia or cancer. An ''ad hoc'' workshop was recently convened am
ong a group of investigators actively involved in the field of allogen
eic stem cell transplantation to discuss the safety issues pertaining
to normal PBSC donors. There was agreement on the following points: (1
) On the basis of available data, it appears that rhG-CSF treatment an
d PBSC collection have an acceptable short-term safety profile in norm
al donors. However, the need for continued safety monitoring was recog
nized. (2) rhG-CSF doses up to 10 mu g/kg/d show a consistent dose-res
ponse relationship with the mobilization (and collection) of CD34(+) p
rogenitor cells, and this dose is acceptable for routine clinical use.
Whether higher doses are superior (or cost effective) remains to be d
etermined, and they may produce more severe side effects. The potentia
l risks of marked leukocytosis (arbitrarily defined as a leukocyte cou
nt of more than 70 x 10(9)/L) have been a concern, and rhG-CSF dose re
duction is performed by many centers to maintain leukocyte counts belo
w this level. (3) Transient post donation cytopenias, involving granul
ocytes, lymphocytes, and platelets, may occur and are at least partly
related to the leukapheresis procedure. These are generally asymptomat
ic and self-limited; follow-up blood counts are not necessarily requir
ed. Reinfusion of autologous platelet-rich plasma should be considered
for donors with expected postdonation thrombocytopenia (platelet coun
t < 80 to 100 x 10(9)/L). (4) Donors should meet the eligibility crite
ria which apply to donors of apheresis platelets, with the exception t
hat pediatric donors may also be considered. Any deviation from these
criteria should have supporting documentation. There is insufficient i
nformation at this time to clearly establish definite contraindication
s for PBSC collection in a hematologically normal donor. Potential con
traindications include the presence of inflammatory, autoimmune, or rh
eumatologic disorders, as well as atherosclerotic or cerebrovascular d
isease. (5) The creation of an International PBSC Donor Registry is de
sirable to facilitate monitoring the long-term effects of the procedur
e. Individual institutions or donor centers are encouraged to establis
h their own PBSC donor follow-up system, preferably with a standardize
d approach to data collection. (C) 1997 by The American Society of Hem
atology.