A phase I/II clinical trial to evaluate a combination of recombinant human platelet-derived growth factor-BB and recombinant human insulin-like growth factor-I in patients with periodontal disease

Journal of Periodontology
T H HowellS E Lynch

Abstract

The primary objective of this study was to assess the safety of recombinant human (rh) platelet-derived growth factor-BB (PDGF-BB) and (rh) insulin-like growth factor-I (IGF-I) when applied to periodontal osseous defects in humans; a secondary objective was to begin to accrue data on the therapeutic dose of these growth factors (GFs) required to stimulate periodontal regeneration. Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design. Following full-thickness flap reflection, test sites received local application of the therapeutic drug delivered in coded syringes by a "masked" investigator. Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I). Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle. Safety analyses included physical examination, hematology, serum chemistry, urinalysis, antibody titers, and radiographic evaluation of bony changes. The primary therapeutic assessment was bone fill measured at re-entry 6 to 9 months after treatment. No local or s...Continue Reading

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Citations

Sep 24, 1999·Molecular Neurobiology·T J Kilpatrick, M Soilu-Hänninen
Apr 20, 2004·Molecular Therapy : the Journal of the American Society of Gene Therapy·Qiming JinWilliam V Giannobile
Nov 28, 2002·Clinical Oral Implants Research·Thorsten R AppelRudolf H Reich
Feb 13, 2001·Journal of Clinical Periodontology·S P LyngstadaasS Gestrelius
Jul 10, 2001·Journal of Clinical Periodontology·K F Al-ShammariH L Wang
Jun 6, 2003·Journal of Clinical Periodontology·Leonardo TrombelliAlessandro Scabbia
Sep 19, 2003·Tissue Engineering·Orasa AnusaksathienWilliam V Giannobile
Jul 19, 2006·Tissue Engineering·Jason W CookeWilliam V Giannobile
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Feb 4, 2011·Expert Opinion on Biological Therapy·Darnell KaiglerWilliam V Giannobile

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