Acellular allogeneic peripheral nerves
Research type
Research Study
Full title
Research and development of acellular allogeneic scaffolds for the repair of peripheral nerve defects
IRAS ID
199203
Contact name
Stacy-Paul Wilshaw
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Peripheral nerve injuries lead to pain and significant disability in many affected individuals. Each year approximately 300,000 people of working age experience a peripheral nerve injury; of these less than 50 % regain full function after treatment. For peripheral nerve damage that results in gaps greater than approximately 3 cm, the current clinical gold standard treatment is surgical repair using a nerve taken from another site on the patient (autograft). Nerves can also be taken from a donor after their death (allograft). This however autografts, requires the sacrifice of a healthy nerve and allografts may be subject to rejection leading to graft deterioration over time.
We have developed methods for treating animal and human tissues including arteries, amniotic membrane and liver that removes the cells and major foreign molecules which stimulate the immunological rejection response. We will apply these methods to human donor tissues to create biological scaffolds, which can be used to treat patients. We will treat the donated tissues with a range of solutions to wash out the cells and foreign molecules and then subject them to a range of tests to ensure that the tissues are not damaged. Sterilization is essential when considering medical devices; a range of sterilization methods will be applied to the decellularised scaffolds tin order to determine which is most suitable. Following treatment and sterilization, we will undertake laboratory studies to assess the biological and mechanical properties of the nerves and quantify any changes when compared to fresh nerves. The immunological response and regenerative potential of the nerve scaffolds will be assessed using mouse and rat models.
If successful, the NHS Blood & Transplant Tissue Services will apply the process to donor peripheral nerves using good manufacturing practice and make the new improved tissues available surgeons for use in patients.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0094
Date of REC Opinion
13 May 2016
REC opinion
Further Information Favourable Opinion