Voice of Regenerative Medicine : Public Comments to CIRM ICOC Board

Tuesday, March 6, 2012

Public Comments to CIRM ICOC Board

San Diego Regenerative Medicine Institute Releases Dr. Parsons’ Public Comments to CIRM ICOC Board Meeting 01/17/2012/Sheraton/Baytower/Bel Aire Ballroom/1380

I come here try to bring board’s attention to fund human ES cell research and leaders in California. Human ES cells are the most potential stem cells for developing therapy & cure, so far only a very small % CIRM awards are for human ES cells. We have developed ground-breaking techniques to turn human ES cells into neurons and heart muscles for cell therapy development, critical to bring cures to many incurable diseases. We are the leaders in stem cell research, doing exactly what California’s stem cell research and cure bond act intent to do, should be prioritized for CIRM funding, but so far we have received a penny support for our important stem cell research from CIRM. I feel that it is my responsibility to come to ICOC meeting to give our input for the common goal of advancing stem cell research & therapy. Therefore, I have a few questions and suggestions I hope the board will consider. I was told I only got 3 mins, so I will make it very brief,

1. Questions regarding CIRM’s stem cell research leadership awards:
a. Why is that CIRM excludes stem cell scientists in California from the stem cell research leadership awards, only scientists out-of-state are eligible?
b. One of Prop71 awards’ requirement is that the PI needs to have demonstrated record of achievement in the areas of pluripotent stem cell and progenitor cell biology and medicine, why is that CIRM gave the stem cell research leadership awards to scientists who have no stem cell research experience? It would be much more helpful for the public to understand if CIRM can list their achievements in stem cell research and leader activities, such as developing ground-breaking stem cell therapy products and research essential to advance the stem cell field that made this person a stem cell research leader.
c. Why there is no human ES cell research leaders awarded?

2. Question regarding the transparency of CIRM pre-application.
We have developed a new cutting-edge technique to turn human ES cells into beating heart muscles efficiently, intent to move forward to develop cell therapy for heart diseases that so far have no cure and no other treatment options through CIRM early translational award. Our research for developing new stem cell therapy for unmet needs exactly met the purpose of CIRM early translational awards, but turned down by pre-application by unfair critiques such as the PI has no drug development experience, not address the issue of immunogenicity. We understand Prop71 is for developing new stem cell therapy, not for drug development company. Human ES cells are considerably less immunogenic than any other cells and tissues, immunogenicity is not a major issues comparing to adult cells and reprogrammed cells. I have demonstrated record of achievement in preclinical developments of pluripotent stem cell therapy products of this award. It is our understanding that it is CIRM’s job to ensure California’s potential stem cell research & therapy development to be funded to develop treatment & cures for those patients CIRM really cares. Those unfair critiques to pre-application have made crucial research & advancements in stem cell therapy development of CA stem cell research & cure act unnoticed, unfunded, could not move forwards. Therefore, we’d like CIRM board to consider more transparent grant review process, such as allow formal appeal or petition for PreApps, to improve CIRM’s transparency and progress.

3. We have developed a ground-breaking technique to convert human ES cells into a large supply of neuronal cells for nerve regeneration for spinal cord repair in clinical trials. Our novel approach will dramatically increase the clinical efficacy for human ES cell-derived cellular products, targeting both acute and chronic patients, a much broader population than Geron’s trial. We submitted our part-I planning grant on time and requested extraordinarily exceptions twice upon request, but for some reason, the proposal was not considered according to the normal grant review procedure. Due to its novelty, its potential for safe and effect treatment, its benefit to those patients CIRM really cares if the cell therapy is developed, and its stem/progenitor activity & advantage/efficiency/safety over Geron’s trial and all other CIRM awarded developments, we’d appreciate it if the board reconsider our extraordinary petition, so critical stem cell therapy development of Prop71 & patients’ hope/need would not be delayed and the progress of California stem cell research and cure act would not be delayed.

Thank you for your patience.

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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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