Biomaterials for soft tissue repair

Added: 13th December 2015

A research group from the University of Manchester asked for regulatory advice during the development of a novel biomaterial for guided repair of soft tissue. The use of scaffolds is a key approach in regenerative medicine, with chemical composition, functionalisation and surface topography all playing key roles in accelerating cellular ingrowth, appropriate biological responses and enduring, site-appropriate regeneration or repair of tissue. With complex materials and multiple potential mechanisms of action, classification is a critical early step in the process which guides all future development activities. We provided classification advice, followed by a detailed regulatory roadmap and ongoing support for development of this novel biomaterial as it progresses towards first clinical use.

"After confirming the right regulatory classification, Alison provided thorough and understandable guidance to help the development of our novel regenerative medicine scaffold. Systematic and timely explanations of the data needed and options at each stage have led to an optimised pathway to first clinical trial in man."

Adam Reid MBChB FRCS (Plast) PhD - NIHR Clinical Lecturer - University of Manchester