Commercialisation potential of a decellularised porcine bladder matrix.

Lead Research Organisation: University of York
Department Name: Biology

Abstract

We have developed a novel procedure to decellularise full-thickness porcine bladder tissue by utilising the bladder's unique capacity for expansion; a patent is in application. The resultant biometerial is highly stable in its non-cross-linked form, non-cytotoxic in cell culture and retains the strength and compliant properties of the native urinary bladder. Prior to commercialisation, further pre-clinical evaluation of the decellularised porcine bladder tissue is required in order to identify benchmark biomechanical properties, investigate the immunological status and determine whether the biomaterial is able to support both in vitro and in vivo recellularisation. This information is necessary in order to identify specific clinical uses and target appropriate commercialisation sectors.
 
Description The overall aim of the project was to conduct specific research on a novel full thickness porcine acellular bladder matrix (PABM) biomerial we had developed in a previous BBSRC grant in order to move towards realising its commercialisation potential. The research involved investigating the immunological status of the PABM in two mouse models in vivo; this showed 1) that the decellularised biomaterial became incorporated and did not cause a foreign body reaction and 2) that the biomaterial did not raise any reaction in galactosyl transferase knock-out (GTKO) mice. We showed only minor changes occurred in biomechanical properties following decellularisation, with no change in ultimate tensile strength and only a small increase in the collagen phase slope indicating a small increase in tissue "stiffness". We also determined the ability of the material to support recellularisation. Improvements to the reproducibility and tracking of the biomaterial were made by introducing a standardised processing procedure, batch numbers and quality control monitoring as part of the laboratory's Quality Review Process.
Exploitation Route We have developed a natural decellularised biomaterial with unique mechanical and material properties that make it highly promising for eventual use in regenerative medicine and reconstructive surgery.
Sectors Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

URL http://www.google.com/patents/WO2007110634A2?cl=en
 
Description The key findings of the research were used to re-enforce the patent (PCT/GB2007/001117) and to augment the technical portfolio of data presented to medical product companies to identify potential licensees. An offer was accepted from Tissue Regenix Ltd to acquire exclusive patent rights ahead of the international filing phase. Additional outputs from the project included 3 publications, 4 meeting presentations and research training of a final year BSc student. A BBSRC studentship was converted to CASE through collaboration with Tissue Regenix Ltd to investigate the role of macrophages in the biomaterial recellularisation process (PhD awarded to Samuel Bullers, University of York, 2013). A further PhD CASE studentship with Tissue Regenix was appointed in Leeds as part of the EPSRC Doctoral Training Centre in Tissue Engineering and Regenerative Medicine. A Regener8 Medical Technologies IKC proof of concept award was made and is ongoing to examine the use of the biomaterial as a urethral onlay free graft for potential use in primary hypospadias repair in a porcine model (in partnership with Tissue Regenix and NHS Blood Transplant Tissue Services R&D). A clinical research fellow was awarded a PhD from Hull York Medical School (2016) based in part on the hypospadias model. Further funding is being sought to examine the homologous use of PABM in bladder augmentation surgery.
First Year Of Impact 2007
Sector Healthcare,Pharmaceuticals and Medical Biotechnology
 
Description Proof od concept award
Amount £100,000 (GBP)
Organisation University of Leeds 
Department Medical Technologies IKC
Sector Academic/University
Country United Kingdom
Start  
 
Description Proof of concept award
Amount £103,416 (GBP)
Organisation University of Leeds 
Department Medical Technologies IKC
Sector Academic/University
Country United Kingdom
Start  
 
Title Improvements relating to decellularisation of tissue matrices for bladder implantation 
Description The invention provides an improved method of producing a natural, acellular matrix scaffold for subsequent use in tissue-engineered replacement of tissues such as the bladder. Decellularisation is carried out on an expanded or distended bladder and the product retains the strength and compliance of natural material. The invention also provides use of the matrix scaffolds as wound healing material and to investigate tissue structure and function in vitro. 
IP Reference WO2007110634 
Protection Patent granted
Year Protection Granted 2007
Licensed Yes
Impact Under preclinical testing for surgical use.
 
Description public engagement 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Civic visit to the laboratory by Lord Mayor of York and Sheriff plus their partners, with reporter.
Year(s) Of Engagement Activity 2016
 
Description public engagement talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Talk to York Vikings Rotary Club
Year(s) Of Engagement Activity 2016