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California Cloning
Published in Tina Stevens, Stuart Newman, Biotech Juggernaut, 2019
When the smoke cleared over the battlegrounds of the 2004 election, California was in possession of a state-sanctioned right to undertake human embryonic stem cell research. The state was also now in possession of an unprecedented type of institution. The California Institute of Regenerative Medicine became the nation’s first state agency dedicated to medical research with a mandate to find cures through the use of stem cells. It was also a state agency completely outside the normal channels of governance, and for which the state had no oversight authority.
Stem Cell Research and the Regulation of a Moving Target
Published in Sarah Devaney, Stem Cell Research and the Collaborative Regulation of Innovation, 2013
The current state of the art is such that significant hurdles must be overcome before the potential of SC research can be tested routinely on human subjects and realised in patients. Risks posed to patients include ‘tumour formation, infection and immunological complications’.94 Studies have shown that certain adult SCs develop into tumour cell lines in the laboratory95 and instances of the development of tumors in recipients of SC therapies have been reported.96 There are also concerns about the stability of embryonic SCs in a ‘partially or completely differentiated state’,97 with SCs grown in culture for prolonged periods displaying significant differences to more recently cultured cells, such as epigenetic and genomic changes.98 Furthermore, human embryonic SCs are prone to generate primitive, undifferentiated tumours in human foetal tissue grafts in mice99 and, while the effects of iPSCs on the human body have not yet been trialled100 the risk of the development of cancers is real.101 While efforts continue to overcome the risks which the application of SCs to the human body can pose,102 given the primitive state of the science, clinical trials of SC therapies are rightly and necessarily few and far between.103 Nevertheless, this is yet another aspect of the development of SC research which is in the process of change, with increasing numbers of researchers seeking and obtaining permission to undertake clinical trials. For example, scientists in the UK and US have indicated their intention to apply for permission to undertake clinical trials using SCs to overcome blindness104 and trials have been approved to explore the efficacy of using embryonic SCs in the treatment of stroke victims.105 The strategic plan of the California Institute for Regenerative Medicine (CIRM) moves from a focus on basic research to clinical application, with the intention that two clinical trial programmes would be approved in due course.106
Patenting in the Public Interest: The California Institute for Regenerative Medicine Model
Published in The American Journal of Bioethics, 2018
The regulations adopted by the California Institute for Regenerative Medicine (CIRM) that apply to its grantees provide a model for publicly funded research patenting in the public interest. CIRM was established through the passage of Proposition 71 in the 2004 election. California voters agreed to fund $3 billion in state bonds to advance the field of regenerative medicine in the state, particularly to support human embryonic stem-cell research. These regulations not only bind CIRM grantees and loan recipients but also apply to their grantees’ collaborators and licensees. Like the Bayh–Dole legislation (35 U.S.C.§,202), CIRM permits researchers to patent their discoveries, but unlike Bayh–Dole, CIRM’s intellectual property provisions require that once their products are commercialized, grantees must share revenue with the state treasury. CIRM is not the only state stem-cell funding program that has such a revenue-sharing provision. For example, the Connecticut stem-cell program does so as well (National Academy of Sciences 2013, 112). It is too soon to know whether CIRM will be able to recoup part of its investment through payment of these royalties.