15 December 2011
Created by a team at King’s College London, these cells were made under especially stringent conditions to meet the requirements for therapeutic use in humans, although they will now be subject to checking to ensure that these standards have been successfully met. This required new approaches to avoid the usual need for animal-derived products for establishing and propagating the cell lines, such as animal enzymes or ‘feeder’ cells.
Cells used for current clinical trials such as for spinal cord repair (see previous news) were originally research-grade products that received exhaustive safety analysis and subsequent approval for use in humans.
Research leader Professor Peter Braude commented: “This first batch of cells is the culmination of nearly ten years of research funded strategically by the Medical Research Council that will keep the UK at the forefront of regenerative medicine”. Other UK research groups reportedly plan to deposit similar cell lines soon.
Comment: These new bespoke clinical-grade cell lines could potentially be used in clinical trials across Europe, potentially speeding transfer of stem cell therapeutics into the clinic, though some have ethical reservations about the medical use of products derived from human embryos. A recent European court ruling blocked patenting of such products on moral grounds (see previous news), a decision that has provoked fury from researchers. This includes public criticism from the Alliance of German Scientific Organizations, which says that the ruling could discredit hES cell research and that regulation should rest with national government. Practice varies considerably across Europe.