More than twelve million patients worldwide are waiting for a corneal transplant – a demand that cannot be met as there is a severe shortage of donor tissue. Particularly affected are patients with diseases of the inner cornea, known as Descemet's membrane with endothelium (DME). Descemet's membrane is one of several layers that make up the cornea in the eye. It is needed for the endothelial cells to adapt and function correctly. In current treatment, the diseased cornea is replaced with a transplant. However, neither primary endothelial cells from donor eyes nor alternative cell sources offer a scalable solution. In addition, new innovative approaches often lack the physiological topography, i.e., the structured surface of the Descemet membrane.
In this project, scientists are developing a human corneal implant that precisely and biomimetically replicates the Descemet membrane and uses stem cells from small human skin samples. To produce the transplant, they are combining several modern technologies:
This combination of processes represents a major technological advance. It solves important challenges posed by previous methods and enables Scientists to produce functional und potentially autologous corneal endothelial tissue in a scalable manner.
The project is based on patent DE 10 2015 205 534 B4. It protects a microstructured surface that replicates the natural topography of the Descemet membrane, as well as its use for the targeted control of cell differentiation.
In this project, scientists are working on experimental evidence that stem cells can grow into fully functional corneal endothelial cells on a biomimetic Descemet structure. To do this, they produce the master structure and use it to form a collagen scaffold, a framework made of collagen whose topography the stem cells recognize. They then isolate the stem cells from skin biopsies and cultivate them under specified conditions. The newly produced transplant is then tested for functionality. This restores the barrier function for maintaining the transparency of the cornea. At the same time, the researchers are developing quality criteria that will enable later clinical application.
With this project, the project team is responding to the global shortage of donor corneas and, for the first time, creating a scalable biological alternative to donor tissue. The project demonstrates how personalized regenerative medicine works in practice and opens up prospects for other types of tissue. At the same time, it strengthens European innovation and production expertise in the field of medical technology and creates new economic opportunities.
Fraunhofer Institute for Production Technology IPT, Aachen
The GECKO research project is funded by the European Union and the state of North Rhine-Westphalia as part of the ERDF/JTF NRW patent validation.
Funding code: 20801536
Grant Program: IN-PV-4-012
Project sponsor: PTJ Projektträger Jülich