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Regenerative Prostheses as Alternative to Donor Corneas for Transplantation to Treat Blindness.

Reference number
Coordinator Linköpings universitet - Institutionen för klinisk och experimentell medicin
Funding from Vinnova SEK 4 696 356
Project duration October 2013 - November 2017
Status Completed

Purpose and goal

India has an enormous burden of corneal blindness, with an estimated 6-7 million afflicted individuals. Cornea blindness is generally treated by cornea transplantation but a severe shortage of donor tissue has 12.7 million patients awaiting transplantation. However, patients with severe pathologies have a high risk of rejecting conventional transplantation even with available donors. Our aim was to develop biomaterials-based implants that as alternatives to donated corneas but in particular, which could be used for high-risk patients who otherwise may not be transplanted.

Expected results and effects

The deliverables for this project were regenerative implants that were tested pre-clinically and then in clinical trials. Recombinant human collagen-phosphorylcholine (RHCIII-MPC) were manufactured in GMP cleanrooms and evaluated in a first-in-human study. Short collagen-like peptide analogs that were more amenable to scale-up were developed and tested in mini-pigs under GLP. A second generation of peptides with a new less toxic crosslinker has just been evaluated in an alkali burn mini-pig cornea model. Clinical studies are planned and regulatory submissions underway.

Planned approach and implementation

Clinical translation was a goal at the outset. We therefore focussed on the transfer of methods from laboratory to GMP manufacturing and then clinical testing after obtaining ethucal/regulatory approvals. Swedish and Indian partners worked closely. PI, trainees and staff exchanges occured over the 4 years. Significantly, a Swedish post-doc is now working as a translational scientist at LVPEI and he will oversee the technology transfer and potential scale-up in manufacturing of collagen peptide-based implants for patient testing and eventual clinical uptake in Indian centres.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 25 November 2019

Reference number 2013-04645

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