Wound stimulation by growth-arrested human keratinocytes and fibroblasts: HP802-247, a new-generation allogeneic tissue engineering product.
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.


CONCLUSIONS
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.
Goedkoop
René
R
Shogu Consulting, Bogis-Bossey, Switzerland.
Juliet
Rodney
R
You
Percy Hou Kang
PH
Daroczy
Judit
J
de Roos
Kees-Peter
KP
Lijnen
Raf
R
Rolland
Eric
E
Hunziker
Thomas
T
D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005347:Fibroblasts / Q000637:transplantation*; D006801:Humans; D015603:Keratinocytes / Q000637:transplantation*; D007869:Leg Injuries / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012883:Skin Ulcer / Q000628:therapy*; D023822:Tissue Engineering; D042442:Vascular Endothelial Growth Factors / Q000032:analysis; D014945:Wound Healing
D042442:Vascular Endothelial Growth Factors