BACKGROUND:HP802-247 is a new-generation, allogeneic tissue engineering product consisting of growth-arrested, human keratinocytes (K) and fibroblasts (F) delivered in a fibrin matrix by a spray device. OBJECTIVE: To identify the preferred dose of HP802-247 based on cell concentration and K/F ratio. METHODS: A multicenter, randomized, double-blind, placebo-controlled, explorative phase II study of 6 different doses of HP802-247 administered once per week for 12 consecutive weeks in chronic venous leg ulcers. RESULTS:HP802-247 was safe and well tolerated and showed increasing efficacy dependent on cell concentration and K/F ratio, in line with in vitro growth factor release data. The mean complete closure rate at week 12 for all patients treated with HP802-247 was 40%, and for placebo it was 33%. In contrast to placebo, all HP802-247 dose groups improved from week 12 to 24. CONCLUSION: As an integral part of a rational tissue engineering product development, this explorative trial identified the preferred dose of HP802-247 for further clinical studies.
RCT Entities:
BACKGROUND:HP802-247 is a new-generation, allogeneic tissue engineering product consisting of growth-arrested, human keratinocytes (K) and fibroblasts (F) delivered in a fibrin matrix by a spray device. OBJECTIVE: To identify the preferred dose of HP802-247 based on cell concentration and K/F ratio. METHODS: A multicenter, randomized, double-blind, placebo-controlled, explorative phase II study of 6 different doses of HP802-247 administered once per week for 12 consecutive weeks in chronic venous leg ulcers. RESULTS:HP802-247 was safe and well tolerated and showed increasing efficacy dependent on cell concentration and K/F ratio, in line with in vitro growth factor release data. The mean complete closure rate at week 12 for all patients treated with HP802-247 was 40%, and for placebo it was 33%. In contrast to placebo, all HP802-247 dose groups improved from week 12 to 24. CONCLUSION: As an integral part of a rational tissue engineering product development, this explorative trial identified the preferred dose of HP802-247 for further clinical studies.
Authors: Lisa Gould; Peter Abadir; Harold Brem; Marissa Carter; Teresa Conner-Kerr; Jeff Davidson; Luisa DiPietro; Vincent Falanga; Caroline Fife; Sue Gardner; Elizabeth Grice; John Harmon; William R Hazzard; Kevin P High; Pamela Houghton; Nasreen Jacobson; Robert S Kirsner; Elizabeth J Kovacs; David Margolis; Frances McFarland Horne; May J Reed; Dennis H Sullivan; Stephen Thom; Marjana Tomic-Canic; Jeremy Walston; Jo Anne Whitney; John Williams; Susan Zieman; Kenneth Schmader Journal: J Am Geriatr Soc Date: 2015-03-06 Impact factor: 5.562
Authors: Lisa Gould; Peter Abadir; Harold Brem; Marissa Carter; Teresa Conner-Kerr; Jeff Davidson; Luisa DiPietro; Vincent Falanga; Caroline Fife; Sue Gardner; Elizabeth Grice; John Harmon; William R Hazzard; Kevin P High; Pamela Houghton; Nasreen Jacobson; Robert S Kirsner; Elizabeth J Kovacs; David Margolis; Frances McFarland Horne; May J Reed; Dennis H Sullivan; Stephen Thom; Marjana Tomic-Canic; Jeremy Walston; JoAnne Whitney; John Williams; Susan Zieman; Kenneth Schmader Journal: Wound Repair Regen Date: 2015-02-13 Impact factor: 3.617
Authors: Gilbert Verbeken; Gunther Verween; Daniel De Vos; Bruno Pascual; Peter De Corte; Cornelia Richters; Arlette De Coninck; Diane Roseeuw; Nadine Ectors; Thomas Rose; Serge Jennes; Jean-Paul Pirnay Journal: Cell Tissue Bank Date: 2011-03-01 Impact factor: 1.522
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Authors: Anja Lena Thiebes; Stefanie Albers; Christian Klopsch; Stefan Jockenhoevel; Christian G Cornelissen Journal: Biores Open Access Date: 2015-06-01