Case Study

Regener8 POC: A permanent solution for hypospadias

Date: August 23, 2014

The treatment of a common developmental issue in young boys could be permanently resolved in an IKC-funded collaborative project between the Universities of York and Leeds.

Hypospadias is a congenital abnormality in which the urethra develops abnormally. The condition often requires multiple or “staged” surgical repairs because the patient’s own tissue is inadequate in quantity and quality. This may lead to complications requiring further corrective surgery.

The clinical need for a method by which enough material is implanted at the primary repair stage to support the repair and reduce the complication rate is being addressed in a Proof of Concept project with the Universities of York and Leeds, led by Professor Jenny Southgate. The collaboration had previously developed a porcine decellularised bladder tissue to provide a natural acellular matrix for use in urological surgery. The next stage, for which funding was required, was to test the material’s use and functionality in a large animal model. “We needed to demonstrate that the material is biocompatible and can integrate with the body,” says Professor Southgate. “The products used currently for this surgical procedure are not made specifically for this use. We believe that our new natural acellular matrix will fully integrate with the patient’s surrounding tissue, leading to faster repair and better outcomes for the patient.”

The York team are collaborating with two partners, Tissue Regenix Group and the NHS Blood and Transplant Service, with a view to moving forward to clinic with either the porcine acellular matrix or a version derived from human bladder tissue.

“The Medical Technologies IKC funding was crucial to the development of this project,” say Professor Southgate. “By proving the concept, the potential risk for industry partners is ameliorated. This material has potential to make a real difference to many patients’ lives, so this funding is a very important step in its transition from research to surgery.”

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