The Centre for Cell Manufacturing Ireland (CCMI) at the National University of Ireland Galway (NUI Galway) and Sexton Biotechnologies announced the approval by an EU Regulatory Authority of a protocol for the manufacture of allogeneic bone marrow mesenchymal stromal cells (MSCs) to be given intravenously to high-risk corneal transplant recipients in the VISICORT Phase 1B clinical trial. For the VISICORT trial, CCMI will manufacture healthy donor (allogeneic) bone marrow MSCs using culture medium enriched with Sexton Biotechnologies' proprietary nLiven PR culture supplement. The MSCs will subsequently be cryopreserved (frozen) and transported to the Charité University Hospital Ophthalmology Department in Berlin, Germany where the trial is to be conducted. Patients with failure of a previous corneal transplant who agree to participate in the VISICORT trial will receive intravenous infusions of MSCs seven days and one day before a full thickness corneal re-transplant. Approval for the cell manufacturing protocol that incorporates the use of nLiven PR human platelet lysate supplement was recently given by the German Regulatory Authority, the Paul Ehrlich Institute (PEI).
Diseases of the cornea are one of the most common causes of visual loss and blindness worldwide and, when severe, require a corneal transplant to restore sight. Although the healthy cornea is protected from damage by the immune system, corneal transplants may be damaged by immune-mediated rejection, which remains the leading cause of corneal transplant failure. Experimental research carried out at NUI Galway over the past 10 years has shown that allogeneic MSCs can suppress the immune response to corneal transplants and prevent rejection. The VISICORT Phase 1B trial will be first human clinical trial to test the safety and feasibility of this cell therapy approach for high-risk corneal transplant patients.
Professor Matthew Griffin of NUI Galway is the coordinator of the VISICORT project has worked closely with the CCMI technical team, led by Andrew Finnerty, who developed the approved manufacturing protocol.
"Safety and consistent quality and availability are paramount to successful manufacture of clinical-grade cell therapy products that meet the rigorous standards of our regulatory authorities. For this complex project, we are very pleased to have a reliable manufacturing process that meets these standards and is not reliant on small-batch culture supplements. We look forward to successful manufacture of allogeneic MSC doses for VISICORT and to the potential application of this cell therapy product to other challenging immune-mediated health conditions," Prof. Griffin said.
"We are very excited to learn of the approval by PEI of the VISICORT Phase 1B Clinical Trial. Whilst our non-irradiated human platelet lysate product, Stemulate, had been used to manufacture cells for multiple clinical trials throughout the globe, recent guidance around pooled blood products drove a need for an irradiated version of the product. VISICORT will be the first EU-approved trial using our proprietary irradiation product, nLiven PR, and hence represents a major milestone for the product. We would very much like to thank our colleagues at CCMI for their collaborative spirit and persistence in making this happen and look forward to continuing to support them through Phase I and beyond," Steven Thompson, Vice President of Sales and Product Management at Sexton Biotechnologies, said.