title: Effect of implantation of Augment(®) Bone Graft on serum concentrations of platelet-derived growth factors: a pharmacokinetic study.
abstract: BACKGROUND
  Augment(®) Bone Graft is a bone graft substitute intended to be used as an alternative to autologous bone graft in the fusion of hindfoot and ankle joints. Augment(®) Bone Graft is a combination device comprised of beta-tricalcium phosphate (β-TCP) and recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB).
  
  
  OBJECTIVE
  This human pharmacokinetic study was undertaken to assess the effect of Augment(®) Bone Graft implantation on the serum concentration of platelet-derived growth factors (PDGFs).
  
  
  METHODS
  Under the terms of a Research Ethics Board-approved protocol, Augment(®) Bone Graft was implanted in patients (n = 7) undergoing hindfoot and ankle arthrodesis procedures requiring graft material. The control cohort of the study (n = 4) received autologous bone graft. The serum concentrations of PDGF isoforms AA, AB and BB in blood samples, obtained prior to and at ten time points (up to 7 days) after surgery, were measured using enzyme-linked immunosorbent assays (ELISA).
  
  
  RESULTS
  The serum concentration of PDGF-BB did not vary significantly from baseline (median of the combined cohorts 3.89 ng/mL) throughout the course of the study. The serum concentrations of PDGF-AA, PDGF-AB and total PDGF did not deviate from their baseline values (medians of the combined cohorts were 2.87, 14.95 and 20.19 ng/mL for PDGF-AA, PDGF-AB and total PDGF, respectively) except for the last time point in which they were increased (medians for the combined cohorts were 4.71, 20.42 and 30.29 ng/mL for PDGF-AA, PDGF-AB and total PDGF, respectively). There were no differences between the two treatment groups with regard to changes in the serum concentrations of PDGF. None of the samples tested contained anti-PDGF-BB antibodies.
  
  
  CONCLUSIONS
  Analysis of the data demonstrated that the serum concentrations of all three PDGF isoforms analysed were unaffected by implantation of Augment(®) Bone Graft.
authors: BioMimetic Therapeutics Inc., 389 Nichol Mill Lane, Franklin, TN 37067, USA. lsolchaga@biomimetics.com
authors: Luis A
authors: LA
authors: Solchaga
authors: Timothy
authors: T
authors: Daniels
authors: Stephen
authors: S
authors: Roach
authors: William
authors: W
authors: Beasley
authors: Leo B
authors: LB
authors: Snel
mesh_terms: D000328:Adult; D000368:Aged; D000843:Ankle Joint; D001174:Arthrodesis / Q000379:methods; D000077214:Becaplermin; D001672:Biocompatible Materials / Q000008:administration & dosage / Q000494:pharmacology*; D002130:Calcium Phosphates / Q000008:administration & dosage / Q000494:pharmacology*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010982:Platelet-Derived Growth Factor / Q000378:metabolism*; D020574:Proto-Oncogene Proteins c-sis / Q000097:blood*; D013997:Time Factors
chemical_list: D001672:Biocompatible Materials; D002130:Calcium Phosphates; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; C485817:beta-tricalcium phosphate; C075278:platelet-derived growth factor A; C095477:platelet-derived growth factor AB; D000077214:Becaplermin