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

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.