Regenerative collagen biomembrane: Interim results of a Phase I veterinary clinical trial for skin repair.

ABSTRACT: Background: The availability of commercial tissue engineering skin repair products for veterinary use is scarce or non-existent. To assess features of novel veterinary tissue engineered medical devices, it is therefore reasonable to compare with currently available human devices. During the development and regulatory approval phases, human medical devices that may have been identified as comparable to a novel veterinary device, may serve as predicate devices and accelerate approval in the veterinary domain. The purpose of the study was to evaluate safety and efficacy of the biomembrane for use in skin repair indications. Methods: In the study as a whole (3 year total length), 15 patients (animals), dogs and cats (male/female, <8 years) with skin lesions of different etiologie

SUBMITTER: Kaasi A 

PROVIDER: S-EPMC6338246 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature