The First Patient In A Clinical Trial Receives Investigational Treatment For 'Wet' Age-Related Macular Degeneration (AMD) Using Retinal Pigment Epithelial (RPE) Cells Manufactured By Roslin Cells
Edinburgh, Scotland, 09th October 2015
Roslin Cells, a leader in the development and manufacture of cell therapies, confirms today that embryonic stem cell-derived Retinal Pigmented Epithelial cells (RPEs), manufactured for Pfizer Inc., have been used in a recently commenced clinical trial designed to test the safety and efficacy of transplanting the sheet of RPE cells behind the retina of the eye to treat people with ‘wet’ age-related macular degeneration (AMD). The trial, which expects to recruit 10 patients in total over the period of 18 months, is a major stepping stone in the London Project to Cure Blindness. The project, initially established 10 years ago, to find a cure for patients with ‘wet’ AMD suffering from vision loss, owes its current success to the fruitful partnership between the University College London (UCL) Institute of Ophthamology, the National Institute for Health Research (NIHR), the Moorfields Eye Hospital and Pfizer Inc.
Roslin Cells was proud to support this prestigious initiative in May 2014 when it was identified as the main contract manufacturing organisation (CMO) providing the RPEs for the clinical trial. Today, 16 months down the line, we are very proud to share the news of a successful surgery on the first patient enrolled in the clinical trial. It is understood that to date no post-surgery complications have been observed. The team hope to determine the patient’s outcome in terms of initial visual recovery by early December (2015).
Janet Downie, Chief Operating Officer of Roslin Cells commented, “We are delighted to be a part of the team supporting this pioneering clinical trial in stem cell therapy that shows so much potential to be life changing for patients suffering from ’wet’ AMD. We are further very excited to see its first recruit being treated with a cell therapy manufactured by our team.”
David Reynolds, Vice President and Cambridge Site Head for Neuroscience & Pain Research, Pfizer Ltd commented: “It is truly rewarding to be part of this project, at Pfizer we believe that great science is accelerated through collaboration and together we can achieve more. Stem cell-derived therapies are a new and evolving area of medical research and we are proud to be at the leading edge of applying these scientific breakthroughs to helping to restore patients’ eyesight.”
The majority of manufacture of RPE cell material took place at Roslin Cells’s GMP Cellular Therapy Manufacturing Facility in Edinburgh, located at the state of art facilities within the Scottish Centre for Regenerative Medicine. The facility has been licensed by the Medicines Healthcare Products Regulatory Agency (MHRA) for the manufacture of human cell therapy products for clinical trials since May 2013.
About Roslin Cells
Roslin Cells is a UK-based leader in the manufacture and development of cell therapies and provides Good Manufacturing Practice (GMP) contract manufacturing services for cell therapy products for clinical use. Headquartered at the Edinburgh BioQuarter - the world-renowned centre of excellence for stem cell research, the Company operates a state of‐the‐art, GMP Cellular Therapy manufacturing facility alongside Scottish National Blood Transfusion Service (SNBTS). In addition to manufacturing established cellular products, Roslin Cells supports commercial and academic clients to develop new cell therapies by providing full process development and translational capabilities including early phase GMP manufacturing of cellular therapies for clinical trials.
The Company is also a leader in the large scale production of stem cells for research and collaborates with researchers across Europe to accelerate the use of stem cells in life science research.
For more information, please contact:
Janet Downie, Chief Operating Officer,
Tel: 44 (0)131 658 5182
Mobile: +44 (0)7500 766 181
Web : www.roslincells.com