Tuesday, June 12, 2012
Clinically-Grade Human Myocardial Grafts Directed from Biologics-Free Human Embryonic Stem Cells for Heart Repair
San
Diego Regenerative Medicine Institute, Xcelthera, La Jolla IVF, and Sanford
Consortium for Regenerative Medicine announce the publication of collaborative original research, titled “Defining Conditions for
Sustaining Epiblast Pluripotence Enables Direct Induction of
Clinically-Suitable Human Myocardial Grafts from Biologics-Free Human Embryonic
Stem Cells”. To date, lacking of a clinically-suitable human cardiac cell
source with adequate myocardium regenerative potential has been the major
setback in regenerating the damaged human heart. Pluripotent human
embryonic stem cells (hESCs) proffer unique revenue to generate a large supply
of cardiac lineage-committed cells as human myocardial grafts for cell-based
therapy. Due to the prevalence of heart disease worldwide and acute shortage of
donor organs or human myocardial grafts, there is
intense interest in developing hESC-based therapy for heart disease and failure.
However, realizing the therapeutic potential of hESCs has been hindered by the
inefficiency and instability of generating cardiac cells from pluripotent cells
through uncontrollable multi-lineage differentiation.
In addition, the need for foreign biologics for derivation, maintenance, and
differentiation of hESCs may make direct use of such cells and their
derivatives in patients problematic. Understanding
the requirements for sustaining pluripotentce and self-renewal of hESCs will provide the foundation for de novo derivation and long-term maintenance of biologics-free
hESCs under optimal yet well-defined culture conditions from which they can be
efficiently directed towards clinically-relevant lineages for cell therapies.
We previously reported the resolving of the elements of a defined
culture system, serving as a platform for effectively directing pluripotent
hESCs uniformly towards a cardiac lineage-specific
fate by small molecule induction. In this
study, we found that, under the defined culture conditions, primitive
endoderm-like (PEL) cells constitutively emerged and acted through the
activin-A-SMAD pathway in a paracrine fashion to sustain the epiblast
pluripotence of hESCs. Such defined conditions enable the spontaneous unfolding
of inherent early embryogenesis processes that, in turn, aid efficient
clonal propagation and de novo derivation of stable
biologics-free hESCs from blastocysts that can be directly differentiated into
a large supply of clinically-suitable human myocardial grafts across the spectrum of developmental stages using small
molecule induction for cardiovascular repair. This
original research article of Parsons et al was
published in Journal of Clinic. Exp. Cardiology Special
Issue on Heart Transplantation.
Mentor Traps
California Institute for Regenerative Medicine (CIRM)’s awards have been repeatedly going to the same group of privileged individuals in CIRM ICOC board members’ universities/institutes, despite they have generated no results. Do those CIRM awardees in the latest CIRM translational round look so familiar? Alan Trounson just had a meeting with Deepak Srivastava of Gladstone, Juan Carlos Izpisua Belmonte of Salk, Ann Tsukamoto and Irv Weissman of Stem Cell Inc, David Baltimore, and Gerald Schatten in Qatar in March. Back little further, CIRM hosted a series of meetings like ‘World Stem Cell Summit’ & ‘Stem Cell Meeting on the Mesa’ to reserve multi-millions CIRM award spots for each single individual of their privileged speakers, including Larry Goldstein, Yang Xu, Martin Pera. Mark Tuszynski, Joseph Wu, David Schubert, Stephen Forman, Thomas Lane, Eric David Adler, Peter Schultz, Renee Reijo Pera. It may help connect the dots if you know Larry Goldstein was among those who invited Alan Trounson back and helped him to get his half million a year profit at the costs of public funds. Larry Goldstein since has conveniently put himself on CIRM scientific advisory board to help set up many unlawful exclusionary eligibility criteria in CIRM RFAs to make sure the money go to himself & those close to him and block any competitors from receiving public funds. The outrages of such financial conflict of interest are stunning. Larry Goldstein alone has single-handedly snapped ~ $30 millions of CIRM funding for himself, which is more than the entire amount of CIRM funding gone into California regenerative medicine industry for stem cell therapy development, and those in Larry Goldstein’s inner circle have snapped other hundreds of millions. What have they done in return? Nothing but false hope they promised! Larry Goldstein loves to show his face in public as a prominent figure for stem cell research, however, do we remember any prominent stem cell research Larry Goldstein has done for CIRM to give him ~ $30 M of public funds? None. Larry Goldstein’s most proud accomplishment is his book “stem cells for dummies”. Who are the dummies? California taxpayers have given Larry Goldstein ~ $30 millions in exchange of nothing but false hope and corruption. From California governor, lieutenant governor, attorney general, controller, treasurer, to state assembly & congressmen, to patients and voters, do we all look like Larry Goldstein’s dummies? What Larry Goldstein has done is millions of times smarter than those stem cell con men on 60 minutes and CNN. When those dummies of Larry Goldstein, including the United State President Obama and some very high-ranked congressmen such as Rick Perry, thought iPS cells (induced pluripotent stem cells) were a breakthrough for stem cell research, Larry Goldstein knew very well from its inception that it was for human cloning, even said ‘to clone himself’ in his seminars to joke about it. With $80 millions of public funds for stem cell research, Larry Goldstein has done nothing good to direct UCSD’s stem cell research, but has probably abused his director’s power to block more UCSD’s stem cell research that might have conflict of interest with him (please see below example of Larry Goldstein’s letters that he would not give other UCSD stem cell researchers access to UCSD stem cell center funded by State’s public funds required by the law to give access to any stem cell researcher in San Diego at SDRMI wordpress).
My mentors all have deep connections in CIRM and are close to Larry Goldstein. Yang Xu loves to say he and Larry Goldstein are buddies. Besides their institutional ICOC board members, Stuart Lipton and Evan Snyder had John Sladek, now Joan Samuelson and Jon Thomas; Jean Loring, Yang Xu, Prue Talbot had Arlene Chiu and David Baltimore, now Ellen Feigal and Alan Trounson. My mentors have been deeply involved in Larry Goldstein’s many strategic partner plots, including the one to sue NIH, then sent Jean Loring’s good friend Mahandra Rao back to head NIH iPS cell center disguised as stem cell research. Their control web in the San Diego scientific community cannot be undermined. In Evan Snyder’s exact words “--- Stuart (Lipton) and John (Reed) are much less tolerant and understanding. Since Stuart is exceptionally well-connected in the San Diego scientific community, and particularly knows Shu Chien (of UCSD), ---”, so anything you do would be difficult. My mentors and their institutions all provided letters of support and institutional letters of support to promise the National Institutes of Health (NIH) to provide research spaces, resources, and training for my stem cell career development to become an independent investigator that were quite easy for them to do (please see below UCSD supportletter as a example), however, none have kept their promises to NIH (please see below DeptChairLetter as a example). When I received the NIH K01 award, I would have never envisioned the difficulties I have to go through, not for the research, but for the conflicts of interest with my own mentors. Evan Snyder wrote the appeal letter to CIRM that got John Reed in trouble all over the news. In that appeal letter, Evan Snyder falsely put many things that David Smotrich, a IVF clinician who does not do research and teaching/training, did not do to defend Burnham’s decision to put him as the principal investigator (PI), not the person who really did the research. Similarly, later on, Evan Snyder very conveniently forgot to mention in his Parkinson disease translational CIRM award that he did not do some of the hESC work he used. I used to wonder why Jean Loring would go to NIH to force me have to put her as my mentor if she later on would not allow me access to NIH’s stem cell center as the center Co-Director I helped her to get. I used to wonder why Yang Xu would ask me to write more grants if he and Larry Goldstein would block the research spaces for the NIH grants I already had. Well, their multi-millions CIRM awards for the work they did not do may explain it all.
My mentors all have deep connections in CIRM and are close to Larry Goldstein. Yang Xu loves to say he and Larry Goldstein are buddies. Besides their institutional ICOC board members, Stuart Lipton and Evan Snyder had John Sladek, now Joan Samuelson and Jon Thomas; Jean Loring, Yang Xu, Prue Talbot had Arlene Chiu and David Baltimore, now Ellen Feigal and Alan Trounson. My mentors have been deeply involved in Larry Goldstein’s many strategic partner plots, including the one to sue NIH, then sent Jean Loring’s good friend Mahandra Rao back to head NIH iPS cell center disguised as stem cell research. Their control web in the San Diego scientific community cannot be undermined. In Evan Snyder’s exact words “--- Stuart (Lipton) and John (Reed) are much less tolerant and understanding. Since Stuart is exceptionally well-connected in the San Diego scientific community, and particularly knows Shu Chien (of UCSD), ---”, so anything you do would be difficult. My mentors and their institutions all provided letters of support and institutional letters of support to promise the National Institutes of Health (NIH) to provide research spaces, resources, and training for my stem cell career development to become an independent investigator that were quite easy for them to do (please see below UCSD supportletter as a example), however, none have kept their promises to NIH (please see below DeptChairLetter as a example). When I received the NIH K01 award, I would have never envisioned the difficulties I have to go through, not for the research, but for the conflicts of interest with my own mentors. Evan Snyder wrote the appeal letter to CIRM that got John Reed in trouble all over the news. In that appeal letter, Evan Snyder falsely put many things that David Smotrich, a IVF clinician who does not do research and teaching/training, did not do to defend Burnham’s decision to put him as the principal investigator (PI), not the person who really did the research. Similarly, later on, Evan Snyder very conveniently forgot to mention in his Parkinson disease translational CIRM award that he did not do some of the hESC work he used. I used to wonder why Jean Loring would go to NIH to force me have to put her as my mentor if she later on would not allow me access to NIH’s stem cell center as the center Co-Director I helped her to get. I used to wonder why Yang Xu would ask me to write more grants if he and Larry Goldstein would block the research spaces for the NIH grants I already had. Well, their multi-millions CIRM awards for the work they did not do may explain it all.
Monday, June 11, 2012
Human Embryonic Stem Cells: The Most Positive Stem Cells --- The Positivity CIRM Not Get
The difference between induced pluripotent somatic cells (iPS cells) and pluripotent human embryonic stem cells (hESCs) is like the difference between a 90 year-old and a 1 year-old. The difference between iPS cells and hESCs is like the difference between CIRM (California Institute for Regenerative Medicine) and Proposition 71 (Prop71). CIRM has been complaining that they have not got much positive publicity. Perhaps, it is because they have not followed the law and regulations to fund the most positive cells on this planet --- the human embryonic stem cells. The law requires CIRM to give Prop71 funds to the most positive hESCs, however, CIRM has been defying the law to fund those negative cells, WYDIWYG (What You Do Is What You Get).
Human embryonic stem cells (hESCs) are not only pluripotent, but also incredibly stable and positive, as dissected by this Dr. Parsons’ research article that only the positive active factors not the negative repressive factors can be found in hESCs. The normality and positivity of hESCs also differentiate hESCs from any other stem cells, such as the induced pluripotent stem cells (iPS cells) reprogrammed from adult cells. The iPS cells are made from adult cells, therefore, iPS cells carry many negative repressive factors of adult cells that hESCs do not have. The opponents of hESC research invented iPS cells and have been trying to make iPS cells sound the same as hESCs so they can take public funds & tax dollars away from stem cell research. However, iPS cells are not the same as hESCs. Those opponents of hESC research are telling the public that iPS cells have the similar gene expression pattern as hESCs, so they are the same. However, they did not tell the public that the most aggressive cancer cells also have the similar gene expression pattern as hESCs. It is those methods used by the opponents of hESC research that could not detect the differences.
Finally, we’d like to thank our readers for the more than 700 comments to our 1st post “iPS cells or man-made junk”, we are overwhelmed by your positive responses.
San Diego Regenerative Medicine Institute and Xcelthera announce the publication of Dr. Parsons’ original research, titled “The Dynamics of Global Chromatin Remodeling are Pivotal for Tracking the Normal Pluripotency of Human Embryonic Stem Cells”. Pluripotent human embryonic stem cells (hESCs) have the unconstrained capacity for long-term stable undifferentiated growth in culture and unrestricted developmental capacity. Packaging of the eukaryotic genome into chromatin confers higher order structural control over maintaining stem cell plasticity and directing differentiation. We recently reported the establishment of a defined culture system for sustaining the epiblast pluripotence of hESCs, serving as a platform for de novo derivation of clinically-suitable hESCs and effectively directing such hESCs uniformly towards functional lineages for cell-based therapies. To unveil the epigenetic mechanism in maintaining the epiblast pluripotence of hESCs, in this original study of Dr. Parsons supported by the National Institutes of Health, the global chromatin dynamics in the pluripotent hESCs maintained under the defined culture were examined. This study shows that the genomic plasticity of pluripotent hESCs is enabled by an acetylated globally active chromatin maintained by Oct-4. The pluripotency of hESCs that display normal stable expansion is associated with high levels of expression and nuclear localization of active chromatin remodeling factors that include acetylated histone H3 and H4, Brg-1, hSNF2H, HAT p300, and HDAC1; weak expression or cytoplasmic localization of repressive chromatin remodeling factors that are implicated in transcriptional silencing; and residual H3 K9 methylation. A dynamic progression from acetylated to transient hyperacetylated to hypoacetylated chromatin states correlates with loss-of-Oct4-associated hESC differentiation. RNA interference directed against Oct-4 and HDAC inhibitor analysis support this pivotal link between chromatin dynamics and hESC differentiation. These findings reveal an epigenetic mechanism for placing global chromatin dynamics as central to tracking the normal pluripotency and lineage progression of hESCs. This original research article of Dr. Parsons supported by the National Institutes of Health was published in Journal of Anatom. Physiol Special Issue on Stem Cell Biology.
Human embryonic stem cells (hESCs) are not only pluripotent, but also incredibly stable and positive, as dissected by this Dr. Parsons’ research article that only the positive active factors not the negative repressive factors can be found in hESCs. The normality and positivity of hESCs also differentiate hESCs from any other stem cells, such as the induced pluripotent stem cells (iPS cells) reprogrammed from adult cells. The iPS cells are made from adult cells, therefore, iPS cells carry many negative repressive factors of adult cells that hESCs do not have. The opponents of hESC research invented iPS cells and have been trying to make iPS cells sound the same as hESCs so they can take public funds & tax dollars away from stem cell research. However, iPS cells are not the same as hESCs. Those opponents of hESC research are telling the public that iPS cells have the similar gene expression pattern as hESCs, so they are the same. However, they did not tell the public that the most aggressive cancer cells also have the similar gene expression pattern as hESCs. It is those methods used by the opponents of hESC research that could not detect the differences.
Finally, we’d like to thank our readers for the more than 700 comments to our 1st post “iPS cells or man-made junk”, we are overwhelmed by your positive responses.
Sunday, June 10, 2012
Human Embryonic Stem Cells --- The Most Positive Stem Cells
San Diego Regenerative Medicine Institute and Xcelthera announce the publication of Dr. Parsons’ original research, titled “The Dynamics of Global Chromatin Remodeling are Pivotal for Tracking the Normal Pluripotency of Human Embryonic Stem Cells”. Pluripotent human embryonic stem cells (hESCs) have the unconstrained capacity for long-term stable undifferentiated growth in culture and unrestricted developmental capacity. Packaging of the eukaryotic genome into chromatin confers higher order structural control over maintaining stem cell plasticity and directing differentiation. We recently reported the establishment of a defined culture system for sustaining the epiblast pluripotence of hESCs, serving as a platform for de novo derivation of clinically-suitable hESCs and effectively directing such hESCs uniformly towards functional lineages for cell-based therapies. To unveil the epigenetic mechanism in maintaining the epiblast pluripotence of hESCs, in this original study of Dr. Parsons supported by the National Institutes of Health, the global chromatin dynamics in the pluripotent hESCs maintained under the defined culture were examined. This study shows that the genomic plasticity of pluripotent hESCs is enabled by an acetylated globally active chromatin maintained by Oct-4. The pluripotency of hESCs that display normal stable expansion is associated with high levels of expression and nuclear localization of active chromatin remodeling factors that include acetylated histone H3 and H4, Brg-1, hSNF2H, HAT p300, and HDAC1; weak expression or cytoplasmic localization of repressive chromatin remodeling factors that are implicated in transcriptional silencing; and residual H3 K9 methylation. A dynamic progression from acetylated to transient hyperacetylated to hypoacetylated chromatin states correlates with loss-of-Oct4-associated hESC differentiation. RNA interference directed against Oct-4 and HDAC inhibitor analysis support this pivotal link between chromatin dynamics and hESC differentiation. These findings reveal an epigenetic mechanism for placing global chromatin dynamics as central to tracking the normal pluripotency and lineage progression of hESCs. This original research article of Dr. Parsons supported by the National Institutes of Health was published in Journal of Anatom. Physiol Special Issue on Stem Cell Biology.
Human embryonic stem cells (hESCs) are not only pluripotent, but also incredibly stable and positive, as dissected by this Dr. Parsons’ research article that only the positive active factors not the negative repressive factors can be found in hESCs. The normality and positivity of hESCs also differentiate hESCs from any other stem cells, such as the induced pluripotent stem cells (iPS cells) reprogrammed from adult cells. The iPS cells are made from adult cells, therefore, iPS cells carry many negative repressive factors of adult cells that hESCs do not have. The opponents of hESC research invented iPS cells and have been trying to make iPS cells sound the same as hESCs so they can take public funds & tax dollars away from stem cell research. However, iPS cells are not the same as hESCs. Those opponents of hESC research are telling the public that iPS cells have the similar gene expression pattern as hESCs, so they are the same. However, they did not tell the public that the most aggressive cancer cells also have the similar gene expression pattern as hESCs. It is those methods used by the opponents of hESC research that could not detect the differences.
The difference between iPS cells and hESCs is like the difference between a 90 year-old and a 1 year-old. The difference between iPS cells and hESCs is like the difference between CIRM (California Institute for Regenerative Medicine) and Proposition 71 (Prop71). CIRM has been complaining that they have not got much positive publicity. Perhaps, it is because they have not followed the law and regulations to fund the most positive cells on this planet --- the human embryonic stem cells. The law requires CIRM to give Prop71 funds to the most positive hESCs, however, CIRM has been defying the law to fund those negative cells, WYDIWYG (What You Do Is What You Get).
Finally, we’d like to thank our readers for the more than 700 hundreds comments to our 1st post “iPS cells or man-made junk”, we are overwhelmed by your positive responses.
Human embryonic stem cells (hESCs) are not only pluripotent, but also incredibly stable and positive, as dissected by this Dr. Parsons’ research article that only the positive active factors not the negative repressive factors can be found in hESCs. The normality and positivity of hESCs also differentiate hESCs from any other stem cells, such as the induced pluripotent stem cells (iPS cells) reprogrammed from adult cells. The iPS cells are made from adult cells, therefore, iPS cells carry many negative repressive factors of adult cells that hESCs do not have. The opponents of hESC research invented iPS cells and have been trying to make iPS cells sound the same as hESCs so they can take public funds & tax dollars away from stem cell research. However, iPS cells are not the same as hESCs. Those opponents of hESC research are telling the public that iPS cells have the similar gene expression pattern as hESCs, so they are the same. However, they did not tell the public that the most aggressive cancer cells also have the similar gene expression pattern as hESCs. It is those methods used by the opponents of hESC research that could not detect the differences.
The difference between iPS cells and hESCs is like the difference between a 90 year-old and a 1 year-old. The difference between iPS cells and hESCs is like the difference between CIRM (California Institute for Regenerative Medicine) and Proposition 71 (Prop71). CIRM has been complaining that they have not got much positive publicity. Perhaps, it is because they have not followed the law and regulations to fund the most positive cells on this planet --- the human embryonic stem cells. The law requires CIRM to give Prop71 funds to the most positive hESCs, however, CIRM has been defying the law to fund those negative cells, WYDIWYG (What You Do Is What You Get).
Finally, we’d like to thank our readers for the more than 700 hundreds comments to our 1st post “iPS cells or man-made junk”, we are overwhelmed by your positive responses.
Bureaucratic CIRM and Alan Trounson Retaliate Regenerative Medicine Startups for Harsh Criticisms
California Institute for Regenerative Medicine (CIRM) definitely has not bothered to seek any input from Regenerative Medicine Startups & Industry or any expertise on human embryonic stem cell (hESC) research of the law Proposition 71 (Prop 71). So, it is not surprise that CIRM would come up with such an incredibly bureaucratic new strategic plan with ~ $ 20 millions annual spending budget of public funds. Just by simply looking at the list of CIRM future plan, anyone can easily tell who were those Ellen Feigal/CIRM closely consulted for their money plan, and who were not. The most key element is actually missing in CIRM’s new strategic plan or has never been consulted by Ellen Feigal/CIRM. Where is Prop 71 in CIRM future plan? Where is stem cell research in CIRM future plan?
As a hESC researcher who supports Prop 71, I really want to say something positive about CIRM. As positive as we were when we said “YES” to Prop 71, however, our experiences with CIRM have barely had anything positive. Not only our inquires and questions regarding giving inputs & grant applications have barely got any positive responses or helps or even any responses from CIRM, but no transparency and accountability have also let CIRM recklessly abuse its power to give California’s lawful hESC research hardship that can only be found in the world’s most bureaucratic agency. Alan Trounson would not consider Regenerative medicine startups’ reasonable and lawful request to remove CIRM RFA’s unlawful “sunk costs” for the sake of Prop 71 stem cell research is just one example of CIRM bureaucracy, which shows CIRM has never changed under its new leadership (see below). We would like to ask Dr. Trounson why you are sitting on half million a year public funds and why bureaucratic CIRM sitting on ~ $ 20 millions annual spending budget of public funds, NOT to ensure Prop 71 stem cell research & cure act funds go to California’s most advanced hESC research for crucial life-saving stem cell research and therapy development to be able to continue, NOT to preserve California’s existing vital stem cell research human resources and research lab resources, but to misappropriate public funds for stem cell research to CIRM internal conflict of interest connections, frauds, and misconducts to destroy valuable stem cell research resources?
As a hESC researcher who supports Prop 71, I really want to say something positive about CIRM. As positive as we were when we said “YES” to Prop 71, however, our experiences with CIRM have barely had anything positive. Not only our inquires and questions regarding giving inputs & grant applications have barely got any positive responses or helps or even any responses from CIRM, but no transparency and accountability have also let CIRM recklessly abuse its power to give California’s lawful hESC research hardship that can only be found in the world’s most bureaucratic agency. Alan Trounson would not consider Regenerative medicine startups’ reasonable and lawful request to remove CIRM RFA’s unlawful “sunk costs” for the sake of Prop 71 stem cell research is just one example of CIRM bureaucracy, which shows CIRM has never changed under its new leadership (see below). We would like to ask Dr. Trounson why you are sitting on half million a year public funds and why bureaucratic CIRM sitting on ~ $ 20 millions annual spending budget of public funds, NOT to ensure Prop 71 stem cell research & cure act funds go to California’s most advanced hESC research for crucial life-saving stem cell research and therapy development to be able to continue, NOT to preserve California’s existing vital stem cell research human resources and research lab resources, but to misappropriate public funds for stem cell research to CIRM internal conflict of interest connections, frauds, and misconducts to destroy valuable stem cell research resources?
From: Alan Trounson [mailto:ATrounson@cirm.ca.gov]
Cc: Jon Thomas; Ellen Feigal
Subject: RE: Request for removal of large up-front investment requirement of co-funding or extending the deadline of co-funding requirement to clinical trial stage of CIRM RFA 12-05 for Regenerative Medicine Start-Up
Cc: Jon Thomas; Ellen Feigal
Subject: RE: Request for removal of large up-front investment requirement of co-funding or extending the deadline of co-funding requirement to clinical trial stage of CIRM RFA 12-05 for Regenerative Medicine Start-Up
Dear Dr. Parsons:
In response to your request for a Presidential exception to the Strategic Partnership RFA, I have decided on the following: CIRM will be unable to grant your request for an exception to the commercial validation requirements. I wish you good luck in your endeavors.
Sincerely,
Alan Trounson
From: Xuejun H Parsons [parsons@SDRMI.org]
To: Alan Trounson
Cc: Jon Thomas; Ellen Feigal; parsons@SDRMI.org
Subject: Request for removal of large up-front investment requirement of co-funding or extending the deadline of co-funding requirement to clinical trial stage of CIRM RFA 12-05 for Regenerative Medicine Start-Up
To: Alan Trounson
Cc: Jon Thomas; Ellen Feigal; parsons@SDRMI.org
Subject: Request for removal of large up-front investment requirement of co-funding or extending the deadline of co-funding requirement to clinical trial stage of CIRM RFA 12-05 for Regenerative Medicine Start-Up
Dear CIRM President Dr. Trounson,
San Diego Regenerative Medicine Institute (SDRMI) LOI for CIRM RFA 12-05 (CIRM Strategic Partnership I Awards), titled “Neuronal Specification of Human Embryonic Stem Cells (hESC) for Developing Nerve Regeneration Cell Therapy Against Spinal Cord Injury (SCI)”, develops novel hESC cell therapy that will enable clinical practice of innovative stem cell therapy for major unmet medical need, extend independent healthy life, reduce the burden of illness and disability for SCI patients, reduce health care burden of major health problems, and meet the mission of CIRM and the goal of California Stem Cell Research & Cure Act (Prop71). Fulfilling the goal of this project will lead to a significant improvement in SCI patient care, dramatically improving the function, wellness, and overall quality of life for SCI patients, compared to no treatment option available at present time to improve the neurologic and motor functions, particularly in patients at the chronic stage. However, CIRM RFA 12-05 contains large up-front investment, notably sunk costs, requirement to small Regenerative Medicine Start-Ups, which creates high barriers to entry for start-ups and is prohibited by the United States antitrust law. Prop71 fund/capital is earmarked for new promising pluriprotent stem/progenitor therapy development. Such large up-front investment requirements would only become a block or high barrier for stem cell start-ups & novel stem cell therapy development and make it difficult for better and more affordable stem cell therapy of Prop71 enter clinical trials and the therapeutic market, and would not become incentives to Prop71’s stem cell therapy development and entry of clinical trials as this CIRM RFA intends to be.
SDRMI is a emerging hESC research and stem cell therapy start-up committed to the mission of Prop71, and has > $10M of assets of clinical-grade human stem cell therapy products and technology platforms, include: Product Prototype: Xcel-hNuP001 & Xcel-hNu001 (Clinical-grade hESC-derived neuronal progenitors & neurons by small molecule induction; Therapeutic sector: Cell therapy products for neurological diseases & injuries). Product Prototype: Xcel-hCardP001 & Xcel-hCM001 (Clinical-grade hESC-derived cardiac precursors & cardiomyocytes by small molecule induction; Therapeutic sector: Cell therapy products for cardiovascular/heart disease). Technology Prototype: PluriXcel-DCS (Defined culture systems for derivation and maintenance of clinical-grade hESCs); PluriXcel-SMI (Lineage-specific differentiation of pluripotent hESCs by small molecule induction, Direct conversion of human pluripotent cells into neuronal progenitors or cardiac precursors and functional neuronal cells and cardiomyocytes). We believe SDRMI’s hESC-based novel stem cell technologies and therapies, targeting to $B of unmet health problems & health care markets, will eventually attract large investment and partnership from pharmaceutical and biotechnology partners.
Therefore, I’d like to request CIRM to remove of the large up-front investment requirement of co-funding or extend the deadline of co-funding requirement to clinical trial stage of CIRM RFA 12-05 for SDRMI’s hESC cell therapy development proposal for spinal cord injury. Given the urgency of this hESC-based cell therapy development project to CIRM’s mission and to SCI patients, I appreciate it if CIRM considers our request.
Saturday, June 9, 2012
CIRM Lucrative RFAs Make Prop 71 Stem Cell Research Impossible to Get Lawful Public Funds Whereas Give Unlawful Frauds the Green Light
California citizens, are we thrilled that our votes actually count?!!! Proposition 29, another lucrative public fund measure, was defeated. In 2004, we said “YES” to Proposition 71; in 2012, we voted “NO” to Proposition 29. So, what changed us?
LA Times’ Michael Hiltzik who said “Trounson and Thomas --- miraculously disingenuous” may be too polite. If take a look at Prop71, probably something all California Institute for Regenerative Medicine (CIRM) ICOC board members should do, the law was almost written bullet-proof for human pluripotent stem/progenitor cells. So far, only human embryonic stem cells (hESCs) fit into that category. However, according to CIRM’s own statistics on their website, ~ $900 millions out of $1.4 billion of Prop71 funds have been awarded to those who are NOT doing pluripotent stem/progenitor research, such as mesenchymal adult cells, endogenous tissue cells, skin cells, drug development, cancer research, gene therapy, antibody therapy, protein therapy, which can go on to become a very long list of selling stem cell frauds & lies where CNN should really look into. In the remaining awards of ~$500 millions for CIRM proudly denounce any public criticisms, many were actually gone to disguised stem cell research, such as abnormal induced pluriptoent somatic cells (iPS cells) invented by those lucrative opponents of hESC research after Prop71 was passed. How can CIRM pretend that they have followed any rules & regulations of the law? How can CIRM pretend that they have made California’ crucial life-saving hESC research impossible to get lawful public funds from Prop71 whereas given unlawful stem cell frauds and bad sciences of their selected individuals the green light as law-abiding?
It’s not just bad sciences or selling stem cell frauds & lies, CIRM has stepped over the ethical boundary to cover up some serious scientific misconducts using unlawful non-transparent grant review procedures. Martin Pera of USC has never done any defined culture work for pluripotent stem cells, we did, how come our proposal could not even pass CIRM pre-application selection, whereas Alan Trounson gave his own personal connection Martin Pera $Ms for developing defined culture systems? Yang Xu of UCSD has never done any heart cell work, we did, how come our proposal could not even pass CIRM pre-application selection, whereas Alan Trounson gave David Baltimore & Martin Pera’s personal connection Yang Xu more $Ms for cardiomyocytes? Why would Alan Trounson deny against the law that we even had any hESC grants for CIRM consideration of Prop71 funding? Although we can only speculate on the magnitude such scientific misconducts from our prospective, it may more widespread than anyone could imagine. How can CIRM pretend denying hESC researchers and research for lawful funding from Prop71 whereas covering up their internal scientific misconducts as law-abiding?
We had some questions for CIRM RFA 12-05 at CIRM Strategic Partnership Webinar (see below), including if CIRM will provide some help for the large up-front investment, otherwise, it would be “sunk costs” not incentives for Prop71 therapy development; this RFA gives green light to drug development and therapy not eligible for Prop71 funds and makes it difficult for new stem cell therapy of Prop71 enter clinical trials and the therapeutic market. However, Ellen Feigal/CIRM have never provided any answers to our questions. Someone at the Webinar specifically asked Ellen Feigal if mesenchymal adult cells, which are not pluripotent stem/progenitor cells of the law, can apply. Ellen Feigal said yes. To clarify it, this person asked Ellen Feigal again the same question. Ellen Feigal said yes again as if she is the law, nothing about Prop71 was mentioned. We all know Ellen Feigal came from UC Davis, which should not make any research of UC Davis become fundable by Prop71 as she has been doing very publicly. I asked CIRM to provide a detailed clarification to why CIRM has given Prop71 stem cell research and therapy development such a difficult time to get funding whereas given those research and development not eligible for Prop71 funds the green light? CIRM has never responded.
LA Times’ Michael Hiltzik who said “Trounson and Thomas --- miraculously disingenuous” may be too polite. If take a look at Prop71, probably something all California Institute for Regenerative Medicine (CIRM) ICOC board members should do, the law was almost written bullet-proof for human pluripotent stem/progenitor cells. So far, only human embryonic stem cells (hESCs) fit into that category. However, according to CIRM’s own statistics on their website, ~ $900 millions out of $1.4 billion of Prop71 funds have been awarded to those who are NOT doing pluripotent stem/progenitor research, such as mesenchymal adult cells, endogenous tissue cells, skin cells, drug development, cancer research, gene therapy, antibody therapy, protein therapy, which can go on to become a very long list of selling stem cell frauds & lies where CNN should really look into. In the remaining awards of ~$500 millions for CIRM proudly denounce any public criticisms, many were actually gone to disguised stem cell research, such as abnormal induced pluriptoent somatic cells (iPS cells) invented by those lucrative opponents of hESC research after Prop71 was passed. How can CIRM pretend that they have followed any rules & regulations of the law? How can CIRM pretend that they have made California’ crucial life-saving hESC research impossible to get lawful public funds from Prop71 whereas given unlawful stem cell frauds and bad sciences of their selected individuals the green light as law-abiding?
It’s not just bad sciences or selling stem cell frauds & lies, CIRM has stepped over the ethical boundary to cover up some serious scientific misconducts using unlawful non-transparent grant review procedures. Martin Pera of USC has never done any defined culture work for pluripotent stem cells, we did, how come our proposal could not even pass CIRM pre-application selection, whereas Alan Trounson gave his own personal connection Martin Pera $Ms for developing defined culture systems? Yang Xu of UCSD has never done any heart cell work, we did, how come our proposal could not even pass CIRM pre-application selection, whereas Alan Trounson gave David Baltimore & Martin Pera’s personal connection Yang Xu more $Ms for cardiomyocytes? Why would Alan Trounson deny against the law that we even had any hESC grants for CIRM consideration of Prop71 funding? Although we can only speculate on the magnitude such scientific misconducts from our prospective, it may more widespread than anyone could imagine. How can CIRM pretend denying hESC researchers and research for lawful funding from Prop71 whereas covering up their internal scientific misconducts as law-abiding?
We had some questions for CIRM RFA 12-05 at CIRM Strategic Partnership Webinar (see below), including if CIRM will provide some help for the large up-front investment, otherwise, it would be “sunk costs” not incentives for Prop71 therapy development; this RFA gives green light to drug development and therapy not eligible for Prop71 funds and makes it difficult for new stem cell therapy of Prop71 enter clinical trials and the therapeutic market. However, Ellen Feigal/CIRM have never provided any answers to our questions. Someone at the Webinar specifically asked Ellen Feigal if mesenchymal adult cells, which are not pluripotent stem/progenitor cells of the law, can apply. Ellen Feigal said yes. To clarify it, this person asked Ellen Feigal again the same question. Ellen Feigal said yes again as if she is the law, nothing about Prop71 was mentioned. We all know Ellen Feigal came from UC Davis, which should not make any research of UC Davis become fundable by Prop71 as she has been doing very publicly. I asked CIRM to provide a detailed clarification to why CIRM has given Prop71 stem cell research and therapy development such a difficult time to get funding whereas given those research and development not eligible for Prop71 funds the green light? CIRM has never responded.
From: Xuejun H Parsons [mailto:parsons@SDRMI.org]
Sent: Tuesday, April 24, 2012 4:38 PM
To: StrategicPartnershipWebinarQuestions@cirm.ca.gov
Cc: 'Xuejun H Parsons'
Subject: Strategic Partnership Webinar Questions
Sent: Tuesday, April 24, 2012 4:38 PM
To: StrategicPartnershipWebinarQuestions@cirm.ca.gov
Cc: 'Xuejun H Parsons'
Subject: Strategic Partnership Webinar Questions
1. Emerging regenerative medicine start-ups have very promising human embryonic stem cell therapy development for clinical trials that would meet the scientific merits of Prop71, but would not be unable to get co-funding from big industry/pharm or have sufficient assets, may not be able to meet the capital requirements of this RFA. Will CIRM provide some kind of help for the capital requirements and partnership between stem cell therapy start-ups and big pharms? Otherwise, the partnership would become a block for stem cell start-ups & stem cell therapy development, not incentives to Prop71’s clinical trial of stem cell therapy as this RFA intends.
2. Prop71 fund/capital is earmarked for pluriprotent stem/progenitor therapy/clinical trials. This RFA does not indicate the clinical trial project should be human pluripotent stem/progenitor cell therapy of Prop71. Will CIRM just fund any kind of clinical trials, such as conventional drug development & pills of company that already had the connections with big pharm/industry/capital (e.g., small molecule or biologics candidates)? New promising stem cell therapy development would not be able to compete with those big drug development companys for Prop71 capitals. This strategic partnership RFA would be more of an incentive to those drug development company/Pharms than to clinical trials of stem cell therapy of Prop71, block the better and more affordable stem cell therapy development of Prop71, and make it difficult for stem cell therapy enter clinical trials and the therapeutic market.
Sunday, June 3, 2012
The Filtered News of CIRM and Stem Cell Research
Can you believe that CIRM even has google connection to filter their news? Wow, CIRM and Alan Trounson collaborate with Chinese government on filtering internet news now? The google search engine for hot-button terms such as stem cell research or CIRM seems have been messed up for quite a while. We noticed that our posts have kept disappearing. Last week CIRM announced their awards to their inner circle again, which came up on top of google search for CIRM, but most of the headlines do not have anything to do CIRM’s internal awards. Wow, what a democracy about the freedom of speech!
Friday, June 1, 2012
Selling A Miracle --- Are Human Embryonic Stem Cells to Be Blamed?
CNN Presents aired the show ‘Selling a Miracle’ --- CNN investigates experimental embryonic stem cell clinics. Stem cell shows, like political talk shows, are not likely to be as enticing as ‘Pirates of the Caribbean’ or ‘Harry Potter’. How many times we feel relieved for the freedom provided by technology miracles to only push a button and be able to skip anything we do not want to see or hear on TV? Unfortunately, I have been trained by taxpayers’ money for so many years to become one of the most resourceful and dedicated human embryonic stem cell (hESC) researchers of the Nation. Finally, I made myself to watch it and realized it’s the usual odd story again. Although it is quite interesting for CNN to expose stem cell frauds, someone is blaming selling stem cell frauds and lies on human embryonic stem cells again. There was a second glim between ‘cells isolated from the nose’ and ‘embryonic stem cells’, which are not isolated from the nose, that made it obvious that CNN had something cut off from the film.
In the 90th, National Institutes of Health (NIH) had invested hundreds of millions of tax dollars on transplanting adult cells, such as neurons or skin cells, either isolated from tissues or made by genetic-engineering, which has never turned out to be anything but waste. It was learned that those adult cells would not survive the transplantation, let alone unavoidable severe immune-rejection and accelerated aging. Companys transplanting adult skin cells had gone bankrupted by the end of last century since those skin grafts were found deteriorating quickly and miserably on patients. Stem/progenitor cells had come up to be a better choice for transplantation and cell therapy. However, the lessons have been short learned. In the past few years, NIH, under the pressure of law-suits brought by the opponents of hESC research and their financial stakes, again has been investing hundreds of millions of tax dollars on making and transplanting adult cells, such as endogenous cells, tissue-derived cells, induced pluripotent somatic cells (iPS cells), trans-differentiated skin cells, and reprogrammed adult cells, which are again turning out to be anything but useful as what had been learned before. Shockingly, California Institute for Regenerative Medicine (CIRM), which seems to be manipulated by the same group of individuals who manipulate the NIH, has also followed the suit of NIH to divert Prop71 public funds that are earmarked for hESC research and protected by a law into making and transplanting adult cells, including endogenous cells, tissue-derived cells, iPS cells, and trans-differentiated skin cells. It is known that those adult cells, NOT hESCs, have severe problems of immune-rejection, not transplantable, not engraftable, and aging. However, both NIH and CIRM reviewers often act like opponents of hESC research and ignore the data/evidence and even well-publicized Geron’s trial for hESCs to use those common problems of adult cells, such as not addressing immunogenicity and not surviving transplantation, against or block hESC proposals. Rudy Jaenisch ‘s reprogramming of adult cells holds hugh stakes in big drug development companys like Pfizer. Such significant financial stakes/conflicts could be very likely to dominate the reviewers’ interests to give biased comments over their scientific integrity to give objective scientific reviews, particularly the power of reviewer can be easily abused under the confidential policy to conceal the reviewer’s identity. At last year’s stem cell meeting on the mesa, someone asked NIH’s iPS cell center director Mahendra Rao what he believed was the most promising area for stem cell investment. Mahendra Rao, a neural stem cell person on dopaminergic neuron, chose diabetes, which has been one of the hardest areas for stem cell therapy development but has no conflict with his own research area, to answer.
Human embryonic stem cells themselves are useless, because they are pluripotent, undecided, not functional. Human embryonic stem cells have to be turned into stem/progenitor/precursor cells of functional cells or functional cells, such as brain cells, heart cells, and bone cells to be useful for therapy. However, CIRM has misappropriated most of Prop71 public funds to waste on experimenting those severe problems for adult cells and on making useless abnormal iPS/trans-differentiated adult cells, while CIRM only needs to follow the law and scientific merits of Prop71 to fund hESC research as the simplest solution to those adult cell problems invented by CIRM board members for the sake of their own financial stakes. For example, CIRM has misused more Prop71 funds on experimenting their invented immunological issue on mice, which is rather a clinical issue than a preclinical translational problem, than the entire amount of CIRM funding gone into emerging growth regenerative medicine industry for resolving the major obstacles of hESC research and therapy. It is those universities’ and research institutes’ financial conflicts of interests or financial stakes to be blamed, not human embryonic stem cells.
In the 90th, National Institutes of Health (NIH) had invested hundreds of millions of tax dollars on transplanting adult cells, such as neurons or skin cells, either isolated from tissues or made by genetic-engineering, which has never turned out to be anything but waste. It was learned that those adult cells would not survive the transplantation, let alone unavoidable severe immune-rejection and accelerated aging. Companys transplanting adult skin cells had gone bankrupted by the end of last century since those skin grafts were found deteriorating quickly and miserably on patients. Stem/progenitor cells had come up to be a better choice for transplantation and cell therapy. However, the lessons have been short learned. In the past few years, NIH, under the pressure of law-suits brought by the opponents of hESC research and their financial stakes, again has been investing hundreds of millions of tax dollars on making and transplanting adult cells, such as endogenous cells, tissue-derived cells, induced pluripotent somatic cells (iPS cells), trans-differentiated skin cells, and reprogrammed adult cells, which are again turning out to be anything but useful as what had been learned before. Shockingly, California Institute for Regenerative Medicine (CIRM), which seems to be manipulated by the same group of individuals who manipulate the NIH, has also followed the suit of NIH to divert Prop71 public funds that are earmarked for hESC research and protected by a law into making and transplanting adult cells, including endogenous cells, tissue-derived cells, iPS cells, and trans-differentiated skin cells. It is known that those adult cells, NOT hESCs, have severe problems of immune-rejection, not transplantable, not engraftable, and aging. However, both NIH and CIRM reviewers often act like opponents of hESC research and ignore the data/evidence and even well-publicized Geron’s trial for hESCs to use those common problems of adult cells, such as not addressing immunogenicity and not surviving transplantation, against or block hESC proposals. Rudy Jaenisch ‘s reprogramming of adult cells holds hugh stakes in big drug development companys like Pfizer. Such significant financial stakes/conflicts could be very likely to dominate the reviewers’ interests to give biased comments over their scientific integrity to give objective scientific reviews, particularly the power of reviewer can be easily abused under the confidential policy to conceal the reviewer’s identity. At last year’s stem cell meeting on the mesa, someone asked NIH’s iPS cell center director Mahendra Rao what he believed was the most promising area for stem cell investment. Mahendra Rao, a neural stem cell person on dopaminergic neuron, chose diabetes, which has been one of the hardest areas for stem cell therapy development but has no conflict with his own research area, to answer.
Human embryonic stem cells themselves are useless, because they are pluripotent, undecided, not functional. Human embryonic stem cells have to be turned into stem/progenitor/precursor cells of functional cells or functional cells, such as brain cells, heart cells, and bone cells to be useful for therapy. However, CIRM has misappropriated most of Prop71 public funds to waste on experimenting those severe problems for adult cells and on making useless abnormal iPS/trans-differentiated adult cells, while CIRM only needs to follow the law and scientific merits of Prop71 to fund hESC research as the simplest solution to those adult cell problems invented by CIRM board members for the sake of their own financial stakes. For example, CIRM has misused more Prop71 funds on experimenting their invented immunological issue on mice, which is rather a clinical issue than a preclinical translational problem, than the entire amount of CIRM funding gone into emerging growth regenerative medicine industry for resolving the major obstacles of hESC research and therapy. It is those universities’ and research institutes’ financial conflicts of interests or financial stakes to be blamed, not human embryonic stem cells.
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