Voice of Regenerative Medicine (VORM). CIRM Board Issued Deceptive RFA 12-05 to Misappropriate Public Funds for Stem Cell Research to Sink Regenerative Medicine Startups and Mandate Conflict-of-Interest Incentives to Large Industry

Voice of Regenerative Medicine (VORM). California Institute for Regenerative Medicine (CIRM) board issued 5^th deceptive RFA 12-05 of the year (CIRM Strategic Partnership I Awards) to misappropriate public funds for stem cell research and therapy development to sink emerging growth Regenerative Medicine Startups, improperly divert public funds away from stem cell therapy development of Prop71, and mandate conflict-of-interest incentives to conventional drug development and commercially non-viable products of large industry against the law.


Human embryonic stem cell (hESC) research and therapy development is emerging growth biotechnology/therapeutic startup in Regenerative Medicine made possible by California Stem Cell Research & Cure Bond Act (Prop71) to develop the next generation of cell based therapeutic solutions to relieve $Bs of health care burden of worldwide major health problems. Prop71 has been the only source of government funding protected by law for clinical development of hESC-based stem cell therapy for unmet medical needs. Despite available new technologies and scientific advances for commercial validation and clinical development of life-saving stem cell therapies provided by the tremendous potential of hESCs, CIRM has been denying emerging growth hESC stem cell therapy development of Regenerative Medicine Startups of lawful funding from Prop71 and millions of patients the opportunity of treatment and cure from the advance of stem cell research. Under CIRM’s new leadership, CIRM board has not issued one single RFA to promote hESC research and stem cell therapy development and help the growth of emerging Regenerative Medicine Startups of the law. Instead, CIRM board continues to issue very deceptive RFAs to misuse public funds to exclusively serve the financial conflicts of interest of CIRM board members. CIRM scientific review boards and Alan Trounson have access to ample information to know that the Geron had already failed their spinal cord trial, but still staged the $20M award to give patients the false hope and waste public funds, so did for hundreds of millions of Prop71 funds CIRM give to not-commercial-validated stem cell frauds such as mesenschymal stem cells/iPS junk cells not eligible for Prop71. Despite public outcry and state’s budget crisis, CIRM board members continue to embezzle public funds for stem cell research on personal uses and overspend on their outrageous salaries and activities/contracts unrelated to stem cell research. Under increasingly public pressure for transparency and accountability, CIRM appears to begin to improve its performance by issuing RFA 12-05 to claim to engage industry to transform into cures the stem cell research it has funded over the last seven years. However, CIRM RFA12-05 is very deceptive, which contains unlawful exclusionary eligibility criteria hidden in its fine-prints and allows conventional drug development and commercially non-viable products not eligible for Prop71 to improperly divert public funds away from stem cell research to serve exclusively unlawful special financial interests of CIRM board members and their drug development companys. CIRM RFA 12-05 contains large up-front investment, notably sunk costs, requirement to small emerging growth startups, which creates high barriers to entry for commercial-validated emerging growth hESC stem cell therapy development of Regenerative Medicine Startups and is prohibited by the United States antitrust law. Prop71 fund/capital is earmarked for new promising commercial-validated pluriprotent stem/progenitor therapy development. Such large up-front investment requirement would only become a block or high barrier for stem cell startups & novel commercial-validated stem cell therapy development and make it difficult for better and more affordable stem cell therapy validated commercially by Prop71 to enter clinical trials and the therapeutic market, and would not become incentives to Prop71’s commercial-validated stem cell therapy development and entry of clinical trials as CIRM RFA 12-05 claims to be. VORM condemns CIRM board members misuse authority for embezzlement of public funds for stem cell research; urges CIRM to follow the law and scientific merits of Prop71 to issue RFAs to provide lawful incentives to emerging growth hESC stem cell therapy development of Regenerative Medicine Startups.

Hardball --- Has California Been Duped by Alan Trounson?

California Institute for Regenerative Medicine (CIRM) former chair Bob Klein did not make any financial gain from Prop71 for himself during his term, so no matter what the history will tell, we have to believe that his true motivation for Prop71 was for stem cell research, and thank him for trying to do a good job in a real world where the money is the biggest temptation. However, CIRM president Alan Trounson has a different story. Alan Trounson has made a big financial gain from Prop71 for himself, so his motivation has been tempted by the money and corrupted by those special interests of CIRM board members. Bob Klein publicly promoted human embryonic stem cell (hESC) research and campaigned government support and funding for it. Alan Trounson has scammed the government officials, most of them have as little scientific knowledge as the general public, and the public with non-viable adult/reprogrammed/genetic-engineered cells of CIRM board members, and has ensured hundreds of millions of Prop71 funds go to greedy unlawful special interests of universities/institutes and waste public funds for stem cell research on activities and a large number of awards/contracts not related to stem cell research. Alan Trounson requested outrageous salary from CIRM for himself, which has not only drawn public outcry, but has also tainted Prop71. Despite his sky-high financial interest in CIRM for himself, the public has given Alan Trounson the benefit of the doubt due to his fame, and has put high hope and trust on him that he would lead the way to fulfill the mission of Prop71. Alan Trounson’ half million a year salary may top the roof among government officials, but is nothing compared to $3 billions of Prop71. The money would be well-spent for the State if he has done a fair job to ensure the funding go to vital opportunities of hESC research and therapy development to generate cures & treatments for major unmet medical needs as the law states. Alan Trounson has been so trusted by CIRM that he is the only person in CIRM to be given the power to bypass the course of CIRM grants, so called extraordinary exceptions in order to preserve an important research opportunity to CIRM’s mission. However, the public records show that Alan Trounson has put CIRM board members’ financial conflicts of interest above the law, and has only used his power to preserve unlawful financial interests of CIRM board members, and even worse, to deprive CA’s important hESC research opportunity of lawful funding from Prop71. Before each round of CIRM awards, Alan Trounson had numerous pre-award meetings with those special interest individuals & groups of universities/institutes of CIRM board on iPS/reprogramming adult cells/cancer cells/genetic-engineering/drug-development/tissue-derived or endogenous non-pluripotent cells before those awardees shockingly surfaced to take funding from CIRM against the law; while set up exclusionary eligibility criteria and non-transparent pre-application procedures to block hESC research opportunity from consideration of lawful funding from Prop71. Alan Trounson even denied those existing hESC proposals from lawful consideration of CIRM funding that would preserve an important stem cell research and therapy opportunity of Prop71. Instead, Alan Trounson has given CA state bond to his out-of-state friend Anthony Atala, so he can be on the editorial board. Alan Trounson has misused CA state bond for stem cell research to stage those out-of-state stem cell impostors for stem cell research leadership awards, including $ 6M to Robert Wechsler-Reya of Sanford-Burnham, $ 6M to Zhigang He of UC Berkeley, and $6 M to a fruit-fly individual of Buck, with CIRM board members, including Kristina Vuori of Sanford-Burnham and Duane Roth of UC connect (also on Sanford-Burnham board), while refused to bring lawful hESC cell therapy development projects urgent to CIRM’s mission and millions of patients to CIRM ICOC board for consideration. So far, all Alan Trounson has done is to misuse his power given by the public to help the financial conflicts of interest of those CIRM board members to deprive hESC research of lawful funding from Prop71 and millions of patients the opportunity of treatment and cure from stem cell research, and turned CA historic Prop71 and the hope for stem cell research into a public show of embarrassment, misconduct, and corruption of CA top-paid state officials. Alan Trounson has betrayed the public’s trust to give California nothing! Has California been duped by Alan Trounson? California citizen, do we have to pay half million a year for a fake? Do we have to pay top money for corruption?

CIRM Grants Reviews Reveal No Peer in Stem Cell Research

Since the beginning, California Institute for Regenerative Medicine (CIRM) has been asking their board members’ institutions to recommend their out-of-state collaborators, strategic partners, consortium members, and favorite kin to CIRM scientific grant review committees. As a result, CIRM scientific grant review committees are full of special interest connections, but really lacking any peers in stem cell research. In those scientists’ eyes, the public is easily fool-able. Although scientific term is required to be as accurate as the technology allows, Shinya Yamanaka put a confusing term to his iPS cells, easily got the National Institutes of Health (NIH) to divert hundreds of millions of tax dollars to human cloning endeavor, and then CIRM to follow suit. Since CIRM board controlled by UCs and large institutes finally got rid of the few human embryonic stem cells (hESCs) advocates on board, including former Chair Bob Klein and patient advocate Don Reed, and installed their loyal servant Ellen Feigal for easy access of freebies, CIRM board’s slightest concern for the law has vaporized and CIRM special interest awards have exploded. Although Alan Trounson does have all the qualification to be a peer in stem cell research, anyone with a magnification glass can easily see that Alan Trounson got a lawyer on his tail, nowadays, any word coming out of Alan Trounson’s mouth is just as safe as Geron’s trial --- no effect whatsoever, only worth to secure his top paid CA state official status. Voice of Regenerative Medicine (VORM) is not CA state government entity, attorney general, oversight committee, or paid review committee to check on those wrongdoers feed on public funds beyond the boundary of scientific misconducts and ethical standards can stop. However, VORM is peer in stem cell research, and will begin to provide independent stem cell critiques that CIRM has been in debt to the public, only for what we are gifted and for the love of sciences.

Below please see Dr. Parsons’ response letter to CIRM uncharacteristic grant reviews to her hESC proposals that meet exactly the scientific merits on criteria for Prop 71 awards recommendation,

Dear CIRM,

San Diego Regenerative Medicine Institute (SDRMI) human embryonic stem cell (hESC) research proposal CIRM Basic Biology IV RFA-11-03 Pre-Application RB4-06272, titled “MicroRNAs in directing pluripotent human embryonic stem cells cardiac lineage specification to cardiomyocytes”, meets exactly the scientific merits on criteria for Prop 71 awards recommendation, including innovative approach; cardiac lineage-specific differentiation of hESCs; ground-breaking new technology for generating cardiac precursors and cardiomyocytes direct from pluriptoent hESCs in high efficiency, purity, and cardiac lineage specificity; focus on genome-scale profiling of miRNAs in the cascade of hESC cardiac progression towards beating cardiomyocytes; essential for revealing molecular determinants in hESC cardiac fate decision and understanding of molecular cardiogenesis in human embryonic development; essential for understanding the basic biology of hESC cardiac lineage specific differentiation and advances of stem cell research of Prop71. However, such important hESC research proposal for understanding the basic biology of hESC cardiac lineage specific differentiation was blocked of lawful funding from Prop71 by CIRM non-transparent, biased, conflict-of-interest, anti-Prop71 objectives and scientific merit review. I’d appreciate it if CIRM gives this important hESC basic biology proposal lawful consideration for funding from California Stem Cell Research and Cure Bond Act (Proposition 71).

CIRM Review: Score: 2, Preliminary data is descriptive and qualitative; totally unclear how the differentiation protocol employed will enable analysis of "stages" of cardiomyogenesis; objectives lack focus, thus results expected to be too diffuse to provide any novel mechanistic insights.

Applicant Response: CIRM pre-application is abstract style, limits words and space, not allow data, description, and anything more than general statement, not enough information for score and critique. Whether the proposal is eligible for CA stem cell research & bond act/Prop71 and critical to CIRM’s mission should be the first and only consideration for pre-selection of grants. All applicants can only describe their data in abstract style of CIRM pre-application format. This proposal focuses on understanding basic biology of hESC cardiac lineage specific differentiation, using novel high efficient cardiac lineage-specific differentiation of pluripotent hESCs by small molecule induction. MicroRNA (miRNA) expression profiling using microarrays is a powerful high-throughput tool capable of monitoring the regulatory networks of entire genome and identifying functional elements of developmental processes in high resolution. This proposal will reveal critical regulators and mechanisms in hESC cardiac fate decisions, thereby aid developing safe and effective hESC-based therapy for heart disease and failure.

As stated in our previous emails, SDRMI Grant Application for CIRM Early Translational II Research Awards Pre-Application RFA-11-02 TR3-05505 “Heart precursors directed from human embryonic stem cells for myocardium regeneration” has met the scientific merit of Prop71, including novel efficient approach, new & better hESC-derived cell therapy product for functional heart muscle regeneration, high stem/progenitor activity for heart muscle regeneration, dramatically increase the clinical efficacy & safety for heart diseases, therapy development critical to Prop71, targeting unmet medical need & urgent to heart patients. However, it was blocked of lawful funding from Prop71 by CIRM non-transparent pre-application with biased, conflict-of-interest, anti-Prop71-objectives and scientific-merit reviewer comments. I’d appreciate it if CIRM gives this important hESC early translational research proposal lawful consideration for funding from California Stem Cell Research and Cure Bond Act (Proposition 71).

SDRMI Grant Application for RFA 10-05 CIRM DISEASE TEAM THERAPY DEVELOPMENT AWARDS Application Number DR2-05339 “Developing human-pluripotent-stem-cell-derived neuron regeneration therapy for spinal cord repair” has met the scientific merit of Prop71, including novel efficient approach, novel stem cell therapy, new & better hESC-derived cell therapy product, high stem/progenitor activity for nerve regeneration that has been lacking, dramatically increase the clinical efficacy & safety, targeting both acute and chronic SCI patients, much broader population and better cell therapy than Geron’s trial, stem cell therapy development critical to Prop71, unmet medical need & urgent to SCI patients. However, CIRM has never brought up this important hESC novel SCI cell therapy development proposal of Prop71 for lawful consideration. Instead, CIRM has diverted Prop71 funding to award unlawful non-pluripotent stem/progenitor cell non-viable projects, such as mesenchymal stem cells, endogenous tissue cells and Stem Cell Inc's adult cells derived from tissues that are not eligible for Prop71 funding. Stem Cell Inc has not made their tissue-derived adult stem cells work for any clinical indications for over 10 years, CIRM should not put them on their top special interest list for funding just because it is Irv Weissman/Stanford’s company. I’d appreciate it if CIRM gives this important hESC novel SCI cell therapy development proposal lawful consideration for funding from California Stem Cell Research and Cure Bond Act (Proposition 71).

Voice of Regenerative Medicine (VORM). CIRM Board Hijacks Prop 71 by Issuing Exclusive Unlawful Reprogramming Adult Cell Initiatives/RFAs and Forcing Unethical and Defective Products to Endanger Public Health

Voice of Regenerative Medicine (VORM). California Institute for Regenerative Medicine (CIRM) board abuses authority to hijack Proposition71 (Prop71) by issuing 3 consecutive unlawful reprogramming adult cell/induced pluripotent somatic cell (iPS cell) initiatives/RFAs 12-02, 12-03, and 12-04, which exclude human embryonic stem cell research and therapy development that the law protect, force CIRM board members’ unlawful human cloning interest onto California consumers, and scam the public with unethical, defective, and non-viable products of large businesses harbored by CIRM board members.

Human embryonic stem cell (hESC) research and therapy is a new forefront in Regenerative Medicine made possible by California Stem Cell Research & Cure Bond Act (Prop71) to develop the next generation of cell based therapeutic solutions for many major health problems. However, so far, CIRM has doled out $ZERO of Prop71 funds to develop better and more affordable hESC therapies and cures of Prop71 for patients suffering from incurable diseases. Prop71 has been the only source of government funding protected by law for derivation and banking of clinically-suitable hESC lines. Despite available new technologies and scientific advances for derivation of clinical grade hESC lines and their functional progenies for therapies, CIRM has been withholding Prop71 funds from hESC research in urgent need of funding, impeding life-saving stem cell therapy development, blocking and delaying the mission of Prop71, and putting millions of patients’ life at risk. Despite public outcry, CIRM board continues to defy the law and issue 3 consecutive unlawful iPS/reprogramming adult cell initiatives/RFAs to exclusively serve the financial conflicts of interest of big institutes and large drug development companys of CIRM board members. CIRM board ignores mounting scientific evidences on that iPS cells/reprogramming adult cells/genetically-engineered cells are abnormal, aging fast, low efficiency, not transplantable/graftable, useless & dangerous for clinical use for patients, and waste of public funds. Reprogramming/genetically-engineering adult cells have no ethical issue of hESCs to prevent them from receiving Federal funding. In fact, reprogramming/genetically-engineering adult cells have been funded by large program/center grants/awards from National Institutes of Health (NIH) and large investment from drug development companys, such as Pfizer and Genentech. Such conflict of interest CIRM RFAs do not have any scientific merits of Prop71 and ethical/financial issues for CIRM board members to make consecutive unlawful demanding to divert funds from Prop71 to their large institutes/businesses to duplicate or supplant their existing funding. Such conflict of interest RFAs determined by CIRM board members only serve the financial conflicts of interest of large institutes and drug development companys of CIRM board members; block vital, better, and affordable new stem cell therapy development of Prop71; force unethical, defective, and non-viable products of large businesses onto consumers; and endanger public health; violating ethical & scientific conduct codes and the United States antitrust law. VORM condemns CIRM board members’ such unlawful and unethical acts; urges CIRM to issue RFAs for derivation and banking of clinical grade hESC lines and their functional progenies for stem cell therapy development; and urges CIRM to follow the law and scientific merits of Prop71 to give funding from California Stem Cell Research and Cure Bond Act to human embryonic stem cell research and therapy development of Prop71.