Regenerys Ltd., the Sheffield- and Cambridge-based regenerative medicine company announces a pilot study of its Adiposet tissue collection, testing and storage service, which has the potential to reduce the number of general anaesthetic and surgical procedures required by patients undergoing breast reconstruction following cancer surgery.
Lipomodelling currently harvests fat by liposuction under general anaesthetic before it is re-injected back into the breast in the same surgical procedure. As well as potentially offering substantial benefits over the use of implants in breast reconstruction, lipomodelling is used in facial aesthetic surgery and is showing potential in scar revision. In order for implanted tissue to survive many patients will require a staged approach to reconstruction with several general or local anaesthetic and liposuction procedures for both obtaining and re-injecting the fat.
The study, the first of its kind in world, aims to evaluate the safety of Regenerys' proprietary process for harvesting and cryopreserving a patient's adipose (fat) tissue for later autologous soft tissue reconstruction. Up to 50 patients will be monitored for up to 6 months following the last reconstruction procedure using the harvested and stored tissue, recording all clinical outcomes.
Chief Investigator Mr P Bhaskar, Consultant General and Oncoplastic Surgeon at North Tees and Hartlepool NHS Foundation Trust, said: "Breast reconstruction following treatment for breast cancer has increased over the past few years. This due to the availability of techniques like lipofilling which provides a long term result for the patients after breast cancer treatment including radiotherapy. Lipofilling is more effective if it is done in stages and small volumes. Patients who are undergoing breast cancer treatment, do not like the idea of going through liposuction repeatedly for reconstructive procedures. Adiposet service provides a unique way of avoiding repeated liposuction procedures and at the same time, obtaining a result that is safe and effective for reconstructing patients after breast cancer treatment. This study involves major reconstructive centres in the country and will soon provide results that will help patients in the future".
Dr Amr Abid, Chief Executive of Regenerys, added: "Up to 80% of breast cancer patients in the UK undergo surgical treatment each year. Although the safety of harvesting and re-injecting the patient's own adipose tissue is well-established, because lipofilling has to be done in stages, and each harvest involves liposuction under general or local anaesthesia, this adds a considerable burden, risk and cost to an already heavily treated population of patients."
The Adiposet service provides a harvest and transport kit, shipping, testing, processing and storage of adipose tissue for future use in autologous reconstructive and cosmetic procedures. The service, processing and kit are proprietary. The collection, processing, storage and distribution are authorised by the Human Tissue Authority, thereby giving patients and surgeons confidence in the safety and viability of the harvested tissue. The Adiposet service, also helps the healthcare provider to substantially reduce the costs and time for the breast reconstruction using lipomodelling.
Patients involved in the study will undergo a single procedure under general anaesthetic to harvest adipose tissue, followed by 2-4 re-injections of their own tissue, performed under local anaesthetic.
The study will recruit from The University Hospital of North Tees Glasgow Royal Infirmary, Broomfield Hospital and Norfolk and Norwich University Hospital.
About the Adiposet Service
Although lipofilling (re-injection of patient's own adipose tissue) can be achieved using only local anaesthesia, harvesting a large volume of adipose is exceptionally painful, and requires a general anaesthetic. Post-harvest recovery can be both long and painful. Re-injection is done in several stages to allow for vascularisation of injected tissue. This staged method also reduces tissue necrosis and the presence of oil cysts, gives better tissue retention and improved patient outcomes. Using the current lipofilling methods available, each stage requires a tissue harvest, and this exposes the patient to a greater number of procedures, local or general anaesthetics with their associated risks and complications, and post-harvest, longer recovery times and discomfort. Use of the Adiposet service provides all the advantages of lipofilling whilst improving the patient journey and reducing both risk and cost.