Tissue Engineered Corneal Endothelium Graft

Background

Corneal dysfunction, and in particular, aging, disease, and trauma of the endothelial layer of the cornea, is the second most common cause of blindness. The standard treatment for corneal endothelial dysfunction is to replace the affected endothelial layer of the cornea with portions of a donor cornea (Endothelial Keratoplasty (EK)).

Currently, the number of EKs performed is limited by the availability of donor corneas and in some cases, cultural or individual aversion to donor transplants and, with an increasingly aging population, the demand for donor corneas will continue to rise. Additionally, tissue rejection of the donor cornea is one of the most common causes of repeat EK procedures (~1 in 4 corneal transplants).

While there are commercially available artificial corneas, these products are only used as a last resort for cases where the entire cornea (not just the endothelial layer) requires replacement and multiple transplant rejections have already occurred. Additionally, artificial corneas are not bioresorbable and have a high adverse effect profile.

Technology

Researchers at the University of Melbourne (UoM) have developed a bioresorbable polymer hydrogel film [Figure 1] that when seeded with autologous or allogeneic corneal endothelial cells (CECs), serves as a tissue engineered corneal endothelium (TECE) graft.  In vivo studies of allogeneic TECE grafts in sheep models conducted in collaboration with the Centre for Eye Research Australia (CERA) demonstrate that the TECE graft can restore function of the corneal endothelium as evidenced by the elimination of corneal oedema (swelling) [Figure 2].

Figure 1. UoM bioresorbable polymer hydrogel film. Scale bar represents 5mm. Thickness ~31mm.

Figure 2. Implantation of TECE graft after stripping of the sheep’s CECs
A. Donor CEC’s grown on hydrogel film
B. Implantation using standard surgical method used in current keratoplastytechniques
C. Negative control at 21d after stripping of CEC’s – note opaque cornea
D. Cell-therapy at 25d post-implantation of TCE – note cornea has cleared; no oedema

Competitive Advantages

  • Features a proprietary bioresobable polymer hydrogel film scaffold
  • Compatible with current EK techniques and equipment
  • Overcomes challenges associated with lack of donor corneas
  • Overcomes cultural or individual aversion to donor transplants
  • Autologous CEC approach eliminates risk of rejection and disease transmission associated with allogeneic cornea transplants

Intellectual Property

PCT/AU2014/000391, Filed 10th April 2014, Biodegradable network polymers for regenerative medicine and tissue engineering; National Phase entry in US, EU, JP, AU, CN, IN, and BR (CA entry planned for 2016)

Inventors:

  • Greg Qiao (Deputy Head of Biomolecular & Chemical Engineering, UoM)
  • Berkay Ozcelik
  • Anthony Blencowe

Collaborators:

  • Mark Daniell (Head of Corneal Clinic, CERA)
  • Karl Brown

Licensing Contact

Tim Spencer
Technology Licensing Services
The University of Melbourne
T: +61 3 8344 6810
E: tim.spencer@unimelb.edu.au

Download the Tissue Engineered Corneal Endothelium Graft flyer.