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Blood, 1 September 2001, Vol. 98, No. 5, pp. 1339-1345
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Thrombopoietin therapy increases platelet yields in healthy
platelet donors
David J. Kuter,
Lawrence T. Goodnough,
John Romo,
John DiPersio,
Randolph Peterson,
Dianne Tomita,
William Sheridan, and
Jeffrey McCullough
From Massachusetts General Hospital, Boston; Washington
University, St Louis, MO; University of Minnesota, Minneapolis; and
Amgen, Thousand Oaks, CA.
The recombinant thrombopoietins have been shown to be effective
stimulators of platelet production in cancer patients. It was therefore
of interest to determine if one of these, pegylated recombinant human
megakaryocyte growth and development factor (PEG-rHuMGDF), could be
used to increase platelet counts and consequently platelet yields from
apheresis in healthy platelet donors. In a blinded, 2-cycle, crossover
study, 59 platelet donors were randomized to receive a single
subcutaneous injection of PEG-rHuMGDF (1 µg/kg or 3 µg/kg) or
placebo and 15 days later undergo platelet apheresis. Donors treated
with placebo had a median peak platelet count after PEG-rHuMGDF
injection of 248 × 109/L compared with
366 × 109/L in donors treated with 1 µg/kg PEG-rHuMGDF
and 602 × 109/L in donors treated with 3 µg/kg
PEG-rHuMGDF. The median maximum percentage that platelet counts
increased from baseline was 10% in donors who received placebo
compared with 70% in donors who received 1 µg/kg and 167% in donors
who received 3 µg/kg PEG-rHuMGDF. There was a direct relationship
between the platelet yield and the preapheresis platelet count:
Placebo-treated donors provided 3.8 × 1011 (range
1.3 × 1011-7.9 × 1011) platelets compared
with 5.6 × 1011 (range
2.6 × 1011-12.5 × 1011) or
11.0 × 1011 (range
7.1 × 1011-18.3 × 1011) in donors treated
with 1 µg/kg or 3 µg/kg PEG-rHuMGDF, respectively. Substandard
collections (<3 × 1011 platelets) were obtained from
26%, 4%, and 0% of the placebo, 1 µg/kg, and 3 µg/kg donors,
respectively. No serious adverse events were reported; nor were there
events that met the criteria for dose-limiting toxicity. Thrombopoietin
therapy can increase platelet counts in healthy donors to provide a
median 3-fold more apheresis platelets compared with untreated donors.

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