Novel sterilisation

• Research type

  Research Study

• Full title

  A novel process for the sterilisation of acellular allografts

• IRAS ID

  204975

• Contact name

  Eileen Ingham

• Contact email

  e.ingham@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  1 years, 4 months, 1 days

• Research summary

  The purpose of this research project is to determine the effects of a novel chemical sterilisation process based on copper chloride and hydrogen peroxide on the biological and biomechanical properties of human acellular bone-patellar tendon – bone grafts (BTB). The overall aim and scope of the project is to define the most appropriate sterilisation treatment for the grafts, to enable translation of the protocol into a Good Manufacturing Practice (GMP) Standard Operating Procedure (SOP) and to transfer the SOP to NHS Blood and Transplant Tissue & Eye Services (NHS BT TES) to introduce as a new clinical product for clinical transplantation purposes.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  16/YH/0188

• Date of REC Opinion

  9 May 2016

• REC opinion

  Favourable Opinion