Regenerative medical technology (impact case study)

Finding effective ways to replace parts of the human body that have been injured or have become damaged due to disease is of high importance to patients and doctors.

The area of regenerative medicine, defined as the process of replacing, engineering or regenerating human tissues or organs to restore or establish normal function, has developed over the last decades to offer treatments for a wide range of conditions. It is now possible, for example, to replace skin, heart valves and also the cartilage between joints.

It is possible to replace damaged tissues with tissues obtained from other human donors, however, this is not without problems, the main one being that of rejection by the patient because their body produces an immune response to the donor tissue.

Professors Eileen Ingham and John Fisher, who lead an interdisciplinary team from Biological Sciences and Engineering, undertook research to address this issue of rejection by developing a method to gently remove the cellular components, including DNA, from donor tissues.

This approach removes all of the components that could cause an immune response. Moreover, the method of removing cells and DNA can also be applied to animal tissue, such as pig tissue, potentially creating a readily available supply of replacement tissues.

A spin-out company, Tissue Regenix, was formed in 2006 to utilise the research and commercialise these products as dCELL®.  The patented procedure is being used to produce a number of regenerative medicine products including skin, heart valves and tendons. The patented procedure is also being used by NHS Blood & Transplant Tissue & Eye Services for application to human donor tissue in the UK. They currently supply dCELL® Human Dermis, which is a decellularised dermal skin allograft used to treat chronic wounds.

There is a need for a longer lasting biologic heart valve replacement which could prevent the trauma of a reoperation in young patients. The dCELL® heart valve regenerates to become part of the patient’s body, providing a more durable repair with a significantly reduced risk of rejection. Over a ten year period, a group of patients in Brazil who have received dCELL® heart valves have been followed up, and shown to have excellent results, with few requiring further surgery.

Another dCELL® product, DermaPure®, is in clinical use for patients with non-healing wounds in the USA. A pipeline of additional dCELL® products for applications including tendon and knee cartilage replacement are under development.