American biotech company WiCell, based in Wisconsin, has agreed to help distribute any stem cell lines created using a new, still controversial, technique developed by Advanced Cell Technologies (ACT). The new technique was reported in Nature on 24 August and describes a 'proof of principle' that stem cell lines can be created from human embryos without destroying the embryo. The controversy has been caused in part by the fact that the research, led by ACT medical director Robert Lanza, did in fact destroy the embryos on which they worked. Lanza maintains that the research was never intended to do more than prove the principle that stem cell lines could be created using the technique based on established PGD methods.
WiCell has become involved in the controversy in their role as a subsidiary of the company Wisconsin Alumni Research Foundation (WARF), which holds patents on eight of the 21 stem cell lines derived before the August 2001 cut-off date for stem cells that may be used in research with federal funding. The subsidiary company WiCell was named last year by the National Institutes of Health as the (US) National Stem Cell Bank. In this capacity WiCell is able to distribute stem cells that are approved for federal funding to other scientists. WiCell believes that the ACT-developed technique may allow new stem cell lines to be created and distributed with White House permission.
Elizabeth Donley, WiCell's executive director, said in a news release, 'We are hopeful that future human embryonic stem cells created by this new process can be approved for federal funding'. Donley continued, 'Increasing the number of federally funded stem cell lines is essential for speeding the development of this important technology to treat many of humankind's most serious diseases and injuries'. There has been criticism that as the ACT paper only describes proof of principle, and that the efficiency of deriving the lines was very low, it could still take many years to develop a substantially increased number of stem cell lines even should the White House approve the procedure. However, Ronald Green, chair of ACT's ethics advisory board, last week said he estimates the company could produce 'at least 50 new cell lines every year'.
This week William M Caldwell IV, Chief Executive Officer of ACT, said in a statement, 'Provided that the federal government is willing to fund future human embryonic stem cell research where it can be demonstrated that the embryo was not harmed, we will do our part in scaling up many new lines'. He continued, 'We are well aware of the impact that delays in advancing new therapies can have on people in need of therapy and provided that the federal government advances legislation in an expeditious manner, we will make the derivation of new lines a company priority'.
It is not yet clear what position the White House will take on the new research. If stem cells genuinely can be derived without destroying embryos, then it would seem to obviate President Bush's objection. However long term effects, even of using PGD, are still unknown and the technique pioneered by ACT could still have the potential to harm embryos. Dr James Battey, chairman of the NIH's stem-cell task force discussing the development this week, said, 'We need clarification from the White House. We've asked the question. We have not yet gotten a response'.