The Cell Therapy Catapult is working with researchers at the University of Newcastle and Newcastle upon Tyne Hospitals NHS Foundation Trust on the options for the future development of their corneal limbal stem cell transplants programme.
Corneal (limbal) stem cell deficiency causes patients constant pain and loss of vision. Several UK hospitals have treated patients using corneal limbal stem cell transplants to date and these include Moorfields in London, plus researchers in Edinburgh, Glasgow, East Grinstead, Liverpool and the Royal Victoria Infirmary in Newcastle upon Tyne. The treatment under investigation at the University of Newcastle and Newcastle upon Tyne Hospitals NHS Foundation Trust involves the transplantation of cultured limbal epithelium derived from the patient’s own healthy eye into their affected eye. This approach has met with some success to date – in a trial reported in 2009 by the Newcastle group led by Professor Francisco Figueiredo, the limbal stem cell transplantation approach was described as a ‘safe and effective method of reconstructing the corneal surface and restoring useful vision’1 for patients with this condition
The group is currently conducting a UK Medical Research Council-funded Phase II trial in 24 patients, to further assess the long-term safety and efficacy of the procedure. Depending on the outcome of the trial, the product may then be ready for approval for treatment of larger numbers of patients. The Cell Therapy Catapult’s work with the team includes analysis of the current clinical trial, plus the associated risks and appropriate mitigation for the manufacturing process. Newcastle has already applied successfully for European orphan drug designation for this cell therapy product, which could expedite future market approval
Click here for more information on cell therapy for corneal diseases, and here for a patient story.