Phase 1 Clinical Trial
Polynerve Clinical Trial: UMaNC (University of Manchester Nerve Conduit)
After extensive pre-clinical development, we have approval from the UK regulatory agency – the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Research Ethics Committee, to enter Polynerve into a Phase 1 Clinical Trial which commenced in August 2017. Adult patients between the ages of 18 – 80 years old with a hand wound and symptoms of nerve injury will be recruited. Assessment is undertaken by specialist Plastic & Reconstructive Surgeons at Wythenshawe Hospital, Manchester University NHS Foundation Trust, and eligible patients will be offered treatment with Polynerve.
Polynerve is an artificial polymer nerve conduit which is absorbed by the body, breaking down slowly into harmless products while the nerve regrows. The internal surface of the nerve tube has microgroove patterning, which is intended to guide the regrowing nerve to speed up repair.
UMaNC is funded by the National Institute for Health Research Invention for Innovation program (NIHR i4i) and is sponsored by The University of Manchester. It is managed by the MAHSC Clinical Trials Unit with support from Greater Manchester Clinical Research Facility. We intend to recruit 12-16 patients over one year with one year follow-up. The primary outcomes of our study are to assess the safety of implanting Polynerve. We will also monitor how well the nerve regrows and nerve function recovers.
For more information please visit our official trial website