Openness, the UK Stem Cell Bank, and the Delivery of Cell Therapies:Conceptual Foundations for Facilitation

Abstract

"This paper is based on my doctoral research on openness and the role of the UK Stem Cell Bank (UKSCB, or Bank) in the delivery of stem cell-based therapies for use in regenerative medicine. Stem cell science and technology hit the news in 1998, when scientists discovered how to isolate human embryonic stem cells (hESCs) from early human blastocysts, giving them access to cells characterised by pluripotency, the capacity to generate any tissue type in the human body. Fourteen years on, the first two hESC-based therapies -- for treatment of spinal cord injury and macular degeneration -- are now undergoing clinical trials. Significant hurdles have, however, yet to be overcome, posing the question as to how policymakers are to approach governance of the use of human stem cell lines to facilitate the goals of regenerative medicine in the face of complexity, uncertainty and controversy. The Bank was established as a vehicle for ethical oversight of hESCs derived from donated embryos, and secondarily makes ethically sourced and quality-controlled cells widely available to qualified researchers. It is highly regarded for its expertise in biological standards and control, and provides international guidance for good practice in the banking and use of stem cell lines. What is at issue is the role of the Bank in the commercialisation and delivery of cell-based products, in conjunction with research."