Response to Comment About NIH Policy

The confusion over NIH funding of embryonic stem cell research reminds me of an evening a couple of decades ago where I had the opportunity to watch Pat Boone perform live. During that performance, Mr. Boone told us a story of sitting in the dark corner of a restaurant in a Las Vegas casino where he suddenly found himself surrounded by Paparazzi and the glare of flash bulbs revealing him cuddling with two young women. “Aha” said one cameraman, “so much for your image as a clean-cut evangelical!” “Pardon me,” said Mr. Boone. “I said these were my ‘Boonies’ not my ‘bunnies.’ Gentlemen, meet my beautiful daughters.”

Important details can be lost in the confusion over terminology. A case in point is the recent article in the Washington Post concerning the National Institutes of Health (NIH) policy for federal funding of human embryonic stem cell lines produced by the Reproductive Genetics Institute of Chicago. These human embryonic stem cell lines are unique in that they display the abnormalities of varied inherited genetic diseases such as cystic fibrosis or muscular dystrophy.

BioTime is excited about our ability to utilize human embryonic stem (hES) cells to make a broad array of highly purified human embryonic progenitor (hEP) cell lines as research products in the near-term. NIH approval relates to federal funding of research for the former only, that is, for human embryonic stem (hES) cells. NIH does not restrict federal funds relating to BioTime’s ACTCellerate lines made from normal hES cells (our primary focus in 2010) or ACTCellerate cell lines made from RGI’s disease cell lines, since these products are diverse differentiated hEP cell lines, not hES cell lines. We confirmed that yet again with the NIH within the last week. While all the planned products for 2010 we discussed in our presentation at the Annual Meeting of Shareholders (https://www.biotimeinc.com/btvideo4.htm) are normal cells (not RGI hES cell lines), we plan to make hEP cell lines from the RGI hES cell lines in 2010. Since our work with hES cell lines is performed with private (BioTime) funding, again, there are no federal restrictions impeding our manufacturing process and the RGI hEP cell lines can be marketed with no NIH restrictions for federally-funded researchers..