Effects of granulocyte–colony‐stimulating factor on potential normal granulocyte donors

McCullough, Jeffrey; Clay, Mary; Herr, G.; Smith, Julius; Stroncek, David F.

doi:10.1046/j.1537-2995.1999.39101136.x

Cited by 43 publications

(34 citation statements)

References 28 publications

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“…Assessing the toxicity of plerixafor, we can conclude that it is perfectly safe and only diarrhea occurs more frequently compared with mobilization with G-CSF alone. According to McCullough et al, 18 rates of G-CSF side effects, which include muscle ache, headache, drowsiness, nausea and other flu-like symptoms, can reach 76%.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of plerixafor in children with malignant tumors failing to mobilize a sufficient number of hematopoietic progenitors with G-CSF

Maschan

Balashov

Kurnikova

et al. 2015

Bone Marrow Transplant

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Mobilization of suitable amounts of PBSCs with granulocyte-CSF (G-CSF) can be difficult in children. We report the results of using plerixafor in pediatric patients who failed to mobilize progenitors with G-CSF-based regimens. Thirty-three patients, median age 9 years (range 1-18 years) and median weight 29 kg (range 10-85 kg) were enrolled into the study. After 4 days of G-CSF stimulation, the median CD34+ cell count in peripheral blood was 10.4 per μL (range 0.27-23.0 per μL). Plerixafor was administered subcutaneously (0.24 μg/kg in 30 patients and 0.3 μg/kg in 3 patients) 11-12 h before apheresis. At the time of apheresis, CD34+ cell counts increased to a median of 44.1 per μL (range 8.4-357.0 per μL), a median 4.4-fold increase. Two patients (6%) failed to mobilize. Thirty-one patients underwent apheresis and in 27 42 × 10 6 CD34+ cells per kg of body weight were collected after one procedure. In total, 31 of 33 patients mobilized successfully and the median number of cryopreserved CD34+ cells was 5.6 × 10 6 /kg body weight (2.7 × 10 6 -27.4 × 10 6 ). Twenty-four patients underwent transplantation. Engraftment was achieved in all but one patient, who died on day +9 after hematopoietic stem cell transplantation. The median time of neutrophil and platelet recovery was day +12 and +16, respectively. Our study confirms that plerixafor has impressive efficacy and very modest toxicity in children.

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Section: Discussionmentioning

confidence: 99%

Efficacy of plerixafor in children with malignant tumors failing to mobilize a sufficient number of hematopoietic progenitors with G-CSF

Maschan

Balashov

Kurnikova

et al. 2015

Bone Marrow Transplant

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“…The fusion protein, at an oral dose of 50 mg͞kg, showed a 5-fold increase of ANC in BDF1 mice. Because G-CSF has been shown clinically to have a nonlinear dose-response (22,23), a comparison of the area under the curve or bioavailability cannot be drawn here at this time. However, this study clearly demonstrates that the orally administered fusion protein does indeed have pharmacological effect.…”

Section: Discussionmentioning

confidence: 99%

Recombinant granulocyte colony-stimulating factor-transferrin fusion protein as an oral myelopoietic agent

Bai

Ann

Shen

2005

Proc. Natl. Acad. Sci. U.S.A.

116

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An expression construct harboring granulocyte colony-stimulating factor (G-CSF)-transferrin (Tf) fusion protein (G-CSF-Tf) was engineered by fusing human cDNAs encoding G-CSF and Tf to explore the feasibility of using Tf as a carrier moiety for oral delivery of therapeutic proteins. The recombinant protein, G-CSF-Tf, was harvested from protein-free, conditioned medium of transfected HEK293 cells. The in vitro studies demonstrated that the purified G-CSF-Tf fusion protein possesses the activity of both Tf receptor (TfR) binding in Caco-2 cells and G-CSF-dependent stimulation of NFS-60 cell proliferation. Subcutaneous administration of G-CSF-Tf fusion protein to BDF1 mice demonstrated a pharmacological effect comparable to the commercial G-CSF on the increase of absolute neutrophil counts (ANC). However, the fusion protein elicited a significant increase in ANC upon oral administration to BDF1 mice, whereas G-CSF had no effect. This study also showed that orally administered G-CSF-Tf elicits a sustained myelopoietic effect up to 3 days, whereas the s.c. administered G-CSF or G-CSF-Tf lasts only 1 day. Furthermore, coadministration of free Tf abolished the increase of ANC by orally delivered G-CSF-Tf, suggesting that the recombinant protein is absorbed via a TfR-mediated process in the gastrointestinal tract. Taken together, we conclude that the Tf-based recombinant fusion protein technology represents a promising approach for future development of orally effective peptide and protein drugs. myelopoiesis ͉ oral delivery ͉ protein drug

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“…However, these side effects are common and occur in up to two-thirds of healthy donors following the administration of a single dose of G-CSF. 41 The side effects may be dependent on the dose of G-CSF administered but are readily relieved by simple analgesia. 41 The concomitant use of glucocorticoids may contribute significantly to the incidence of insomnia.…”

Section: Adverse Effects Of Granulocyte Donationmentioning

confidence: 99%

“…41 The side effects may be dependent on the dose of G-CSF administered but are readily relieved by simple analgesia. 41 The concomitant use of glucocorticoids may contribute significantly to the incidence of insomnia. Concerns have been raised regarding the use of repeated doses of glucocorticoids and the risk of posterior subcapsular cataracts (PSC).…”

Section: Adverse Effects Of Granulocyte Donationmentioning

confidence: 99%

Granulocyte transfusions in the G-CSF era. Where do we stand?

Robinson

Marks

2004

Bone Marrow Transplant

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Effects of granulocyte–colony‐stimulating factor on potential normal granulocyte donors

Abstract: In a granulocyte donation program involving G-CSF stimulation, about two-thirds of donors would experience one or more side effects, but these would usually be mild and well tolerated.

Cited by 43 publications

References 28 publications

Efficacy of plerixafor in children with malignant tumors failing to mobilize a sufficient number of hematopoietic progenitors with G-CSF

Efficacy of plerixafor in children with malignant tumors failing to mobilize a sufficient number of hematopoietic progenitors with G-CSF

Recombinant granulocyte colony-stimulating factor-transferrin fusion protein as an oral myelopoietic agent

Granulocyte transfusions in the G-CSF era. Where do we stand?

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