Voice of Regenerative Medicine : Voice of Regenerative Medicine (VORM). CIRM RFA Lacks The Objectives of Prop 71 and Uses Unlawful Eligibility Criteria to Exclude the Regenerative Medicine Workforce and Expertise

Monday, April 30, 2012

Voice of Regenerative Medicine (VORM). CIRM RFA Lacks The Objectives of Prop 71 and Uses Unlawful Eligibility Criteria to Exclude the Regenerative Medicine Workforce and Expertise

Voice of Regenerative Medicine (VORM). CIRM RFA 12-01 (new faculty physician scientist translational research awards) lacks the objectives of California Stem Cell Research & Cure Bond Act (Prop71) and CIRM board uses unlawful eligibility criteria to exclude the regenerative medicine workforce and expertise.

Human embryonic stem cell (hESC) research and therapy is an emerging biotechnology/therapeutic sector in Regenerative Medicine that are made possible by California Stem Cell Research & Cure Bond Act (Prop71) to develop the next generation of cell based therapeutic solutions for major health problems that so far have no cure. The driving force, technology, innovation, and expertise of hESC-based regenerative medicine reside in biotechnology/therapeutic sector of stem cell research and development, not in medical schools of CIRM ICOC board members. None of the Nation’s top Medical Schools exclude faculty with only PhD degree, the major and elite research workforce. However, the unlawful eligibility criteria in CIRM RFA 12-01 determined by CIRM board members exclude the regenerative medicine workforce and expertise, violating ethical standards and the United States antitrust law. Such deliberately exclusionary RFA issued by CIRM only serves the conflicts of interest of CIRM ICOC board members and consolidates the large institutes/businesses’ control over the regenerative medicine industry, hurting new technology development of the emerging industry of regenerative medicine and millions of patients in urgent need of such stem cell therapy made possible by Prop71. VORM strongly opposes such exclusionary RFA and urges CIRM to issue equivalent RFA to support the entrepreneurs and workforce of regenerative medicine industry in order to develop better and more affordable human embryonic stem cell therapies intended by CA law Prop71 for patients suffering from incurable diseases.

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Public Interest

The successful derivation of human embryonic stem cell (human ES cell) lines from the in vitro fertilization (IVF) leftover embryos is considered as one of the major breakthroughs of the life sciences. The pluripotent human ES cells, derived from the inner cell mass (ICM) or epiblast of human blastocyst or human embryos, have both the unconstrained capacity for long-term stable undifferentiated growth in culture and the intrinsic potential for differentiation into all somatic cell types in the human body, holding tremendous potential for human tissue and function restoration. Therefore, human ES cells have been regarded as an ideal source to provide an unlimited supply of large-scale well-characterized human specialized cell types for cell-based therapies to resolve some worldwide major health problems, such as neurodegenerative diseases, paralysis, diabetes, and heart diseases. A small portion of the millions of excess embryos currently stored in the IVF clinics worldwide, which are otherwise destined for destruction, could potentially be an unlimited source to deliver in the future a whole range of therapeutic treatments for tissue and function restoration in patients with life-threatening diseases and injuries. However, human ES cell research has generated intense public interest as well as controversy due to concerns of products of human ES cell cultures that can only be obtained by the use, involving their destruction, of human embryos. The recent years’ court battles on Federal funding for human ES cell research in the United State (US) as well as the patentability of US and international patents directed to human ES cell technologies have also highlighted the decade long ethical, moral, social, and legal controversy surrounding the public interest of human ES cells involving destruction, commercial or industrial uses of human embryos. As neurodegenerative and heart diseases incur exorbitant costs on the healthcare system worldwide, there is a strong focus on providing newer and more efficient solutions for these therapeutic needs. Millions of people are pinning their hopes on human ES cell research. California voters have passed Proposition 71 to designate $3B public fund to support pluripotent human ES cell research and therapy development for the benefit of public health. In spite of ethical debates surrounding the ownership and funding issues of human ES cells, in the case of many incurable or hitherto untreatable life-threatening or devastating diseases, supporting human ES cell research is crucial to driving the advance of medicine to provide optimal regeneration and reconstruction treatment options to improve the function, wellness, and overall quality of life. To answer the intense public interest surrounding human ES cell research and enormous public healthcare benefits thereof, Voice of Regenerative Medicine provides a ground of public debate or voice or blog for the controversies surrounding public interest of human ES cells centering on scientific, economic, ethical, moral, social, financial conflict of interest, and legal issues, to increase public awareness and understanding of the scientific advancement of human ES cell research, and of the importance, urgency, and tangible benefits of human ES cell-based regenerative medicine to improving the function, wellness, and overall quality of life for patients suffering from incurable or hitherto untreatable life-threatening or devastating diseases; to increase public support for human ES cell research; to improve policy making and funding situation for human ES cell research, and to identify and disclose publicly those scientific, economic, ethical, moral, social, financial conflict of interest, and legal issues that have impeded the progress of human ES cell research and stem cell therapy development, introduction of medical innovations and new business opportunities based on human ES cell research, and bringing new therapeutics into the market.

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