Since President Obama repealed research restrictions on human embryonic stem cells (hESCs) in 2009, hESC research has expanded significantly. Before the repeal there were 20 hESC-endorsed lines available for government research funding, now there are 128.
While government funding has been more accessible, investors have still been leery of investing in stem cell companies that use hESCs. There is still a great deal of concern regarding the political environment for this kind of research and many are concerned that if President Obama does not get reelected in 2012 that government funding will again be drastically reduced and that many hESC companies will not be able to survive the cuts. Although the increase in hESC lines available for government funded research has given a boost to the industry, other non-embryonic stem cell work is still funded at a significantly higher rate. According to a recent article in Bloomberg titled “Embryonic Stem-Cell Approvals Rise,” the National Institutes of Health spent $414 million on other non-embryonic Stem Cell Research and only $164 million on government-funded hESC research in 2010.
Despite the difficulties in raising investment capital for hESC therapies, two companies have been successful in receiving approval from the Food and Drug Administration (FDA) for clinical trials. In 2009, Geron Corporation received clearance from the FDA for the first clinical study of hESCs in therapy. The Phase I study, for treatment of spinal cord injury, is ongoing.
Earlier this year, Advanced Cell Technology, received FDA approval for a Phase I/II clinical trial to evaluate the injection of eye cells developed from hESCs to treat Stargardt’s macular dystrophy and dry age-related macular degeneration. According to a press release from the company, dated July 14, 2011, the first patients have begun receiving treatment.
Many believe that in order to shore up investment and public/political support these clinical trials must be successful and produce a therapy that works. If the public learns about the importance of these therapies and that they can cure illnesses for which there are no other cures, spinal cord injury for example, then support for hESC research will gain the momentum necessary to expand and grow. A great deal is riding on these initial clinical studies and continued government-funded research and support in this area.