Letter to NIH Director Francis Collins

Dr. Francis Collins
Director, National Institutes of Health

1 Center Drive, MSC 0148 (Room 126)
Bethesda, MD 20892-0148
Fax: 301-402-2700
Email: francis.collins@nih.gov

Subject: Urge NIH to increase funding and support for human embryonic stem cell research and new stem cell research investigator

Dear NIH Director,

Thank you for your recent visit to San Diego research & biotech community to promote increasing funding for NIH and finding a cure for Parkinson’s disease (PD). Human embryonic stem cell (hESC) cell therapy derivatives hold tremendous potential for tissue and organ regeneration and function restoration. Clinical applications of hESC therapy derivatives provide the right alternative for many incurable diseases & major health problems that the conventional mode of drugs & treatments cannot, such as heart disease and failure, Parkinson’s diseases, ALS, Alzheimer disease, stroke, brain & spinal cord injuries. Each single one of those world-wide major health problems cost the health care system more than $10 billion annually. In particular, hESC neuronal & cardiomyocyte therapy derivatives are currently the only available human cell sources with adequate capacity to regenerate neurons & contractile heart muscles, vital for CNS and heart repair in the clinical setting. The loss of NIH funds to hESC research threatens the future of existing hESC projects and the ability for new investigators to get funding to continue hESC research and career or begin new studies, which are crucial to improving the human health and fighting human diseases, particularly those major health problems of US, such as PD and heart disease.

Recent advances and breakthroughs in San Diego Regenerative Medicine Institute (SDRMI) hESC research have overcome some major obstacles in bringing hESC therapy derivatives towards clinical applications. SDRMI & Xcelthera have established human stem cell technology platforms for defined culture systems for derivation and maintenance of clinical-grade pluripotent hESCs (PluriXcel-DCS) and lineage-specific differentiation of pluripotent hESCs by small molecule induction for direct conversion of pluripotent hESCs into neuronal cells or heart muscle cells for developing safe and effective stem cell therapies (PluriXcel-SMI). Such milestone advances and medical innovations in SDRMI & Xcelthera hESC research enable generation of a large supply of high purity clinical-grade hESC neuronal (Xcel-hNuP & Xcel-hNu) & heart (Xcel-hCardP & Xcel-hCM) cell therapy products for treating neurological & heart diseases & injuries. Please go to our websites at http://www.sdrmi.org & http://www.xcelthera.com to see SDRMI & Xcelthera stem cell research breakthrough publications, human stem cell therapy products and technology platforms, and watch videos of hESC heart beats (hESC-derived heart muscle cells) & slideshow of evolution of CNS neuron cells from hESCs by SDRMI & Xcelthera exclusive human stem cell technique PluriXcel-SMI.

Increasing current NIH funding for hESC research is vital to driving the advance of medicine to provide treatment options for many major world-wide incurable diseases, such as Alzheimer disease, Parkinson’s disease, ALS, heart disease. Given the limited capacity of the CNS & heart for self-repair, transplantation of hESC neuronal & heart cell therapy derivatives holds enormous potential in cell replacement therapy, representing most promising therapeutic approaches closest to provide a cure. Increasing funding for hESC research would be crucial to relieving health care burden, therefore, budget deficit in the future. However, although President Obama acted very quickly to relax the NIH policy on hESC research in March 2009, so far NIH under your directing have cut funding for hESC research to a level worse than that under pervious Bush administration by a Republican President or previous NIH director. During Obama administration led by a Democrat President, crucial hESC research and advances cannot proceed, and existing national hESC research labs and resources that had been open for research progress even in Bush administration have been shut down due to lack of funding. On the other hand, NIH under your directing have wasted hundreds of millions of taxpayer money on adult stem cell frauds and scams and fake science, such as on making very dangerous malicious cancer cells from skin by calling it as induced pluripotent stem cells (iPS cells, no scientific evidence for self-renewal by the definition of stem cells) to endanger public health. In last few years, NIH under your directing have wasted > $300 millions on iPS cells (putting oncogenes into the skin cells of lab rats by falsely claiming it as adult cell alternate for hESCs), examples include Deepak Srivastava of USF (NIH U01HL100406) ~ $ 7 million, George Daley of Harvard U. (NIH U01HL100001) ~ $ 7 million, Robert Robbins of Stanford U (NIH U01HL099776) ~ $ 7 million, Charles Murry of U. Washington (NIH P01HL094374) ~ $ 10 million, Alysson Muotri of UCSD (NIH 1DP2OD006495) ~ $5 million, John O'Shea of National Institute of Arthritis And Musculoskeletal And Skin Diseases (NIH 1ZICAR041190) ~ $ 14 million. While funding for hESC research has been reduced from ~ $80 millions in Bush administration to < 10 millions annually in Obama administration. Please see this website http://search.engrant.com for more information. As NIH new investigator, my critical hESC research projects relevant to understanding the human development and fighting human diseases & major US health problems, such as heart diseases and PD, have kept receiving NIH flawed reviews with apparent biases/COI and scores not reflecting the overall impact and scientific merit of hESC research grant applications. Therefore, we’d like to urge NIH to take action to have high level of transparency and high standard of review for NIH grants review processes in Center for Scientific Review, particularly for stem cell research projects, increase NIH funding for hESC research and new stem cell research investigator, and stop funding stem cell frauds & scams & fake science with taxpayer money. 

CIRM Continue to Cover Up Unlawful Practice By Using Biased Pre-Application to Deny Prop71 Funding for Stem Cell Research But Give Conflicts of Interest Preferential Treatment

If anyone wants to see hard core denial, California Institute for Regenerative medicine (CIRM) would be a very good example. Although evidences and signs of conflicts of interest (COI) in CIRM RFAs, grant reviews, and awards have been widespread and as red as monkey’s butt, the only people who cannot see their COI are CIRM themselves, the only people who think their red butt has been well covered are CIRM themselves. So far, CIRM president Alan Trounson has totally denied there were any COI in CIRM grant reviews and awards. Recently, it seems CIRM chair Jon Thomas finally stepped ahead of Alan Trounson to address potential conflicts within this agency to appeal to the press. However, for CIRM applicants who have long been tired of hearing ICOC and CIRM press releases to screw hundreds of millions of Prop 71 together with stem cell research and scientific integrity beyond the justification of any ethics and research integrity committee, nothing has changed. If anyone predicted that human embryonic stem cell (hESC) research would possibly lose competition to MSC junk cells, tissue adult cells, disease cells, iPS cell scam, and fake science in applying for funding from a Proposition for hESC research, probably no one would believe it. But that is the today’s reality, that is what CIRM did with their unfair competition practice to CA $1.5 billion awards of Prop 71 in front of an oversight committee that comprises Dean, President, CEO of CA most prestigious universities and research institutions who represent the best of a society can offer.

CIRM RFA 13-01 LOI: Application Number: DR3-07198

Project Title: Clinical Development of Human Embryonic Stem Cell (hESC) Neuronal Therapy Derivatives for Nerve Regeneration Following Spinal Cord Injury (SCI)

Project Summary: There is a large unfulfilled healthcare need to provide treatment to improve the neurologic and motor functions following SCI. Human stem cell transplantation represents a promising therapeutic approach closest to provide a cure to restore the normal nerve tissue and function. However, to date, the lack of a clinically-suitable source of engraftable human stem/progenitor cells with adequate neurogenic potential has been the major setback in developing safe and effective cell-based therapies for regenerating the damaged or lost CNS structure and circuitry. Despite some beneficial outcomes, the prototypical neuroepithelial-like nestin-positive neural stem cells (hNSCs) appeared to exert their therapeutic effect primarily by their non-neuronal progenies through producing trophic and/or neuro-protective molecules to rescue endogenous host neurons, but not related to regeneration from the graft or host remyelination. Pluripotent human embryonic stem cells (hESCs) proffer cures for a wide range of neurological disorders by supplying the diversity of human neuronal cell types in the developing CNS for repair. However, realizing the therapeutic potential of hESC derivatives has been hindered by conventional approaches for generating functional cells from pluripotent cells through uncontrollable, incomplete, and inefficient multi-lineage differentiation that is often followed by phenotypic heterogeneity and instability, hence, a high risk of tumorigenicity. To overcome the major obstacles in therapeutic application of hESCs, we have established human stem cell technology platforms for defined culture systems for derivation and maintenance of clinical-grade pluripotent hESCs (PluriXcel-DCS) and lineage-specific differentiation of pluripotent hESCs by small molecule induction for direct conversion of pluripotent hESCs into neuronal progenitors and neuronal cells that are highly neurogenic in vitro and in vivo (PluriXcel-SMI), which dramatically increases the clinical efficacy of graft-dependent repair and safety of hESC-derived cellular products. This technology breakthrough enables well-controlled efficient generation of a large supply of high purity clinical-grade hESC neuronal derivatives (Xcel-hNuP & Xcel-hNu) with adequate capacity for CNS regeneration as cell therapy products to be translated to patients in clinical trials for nerve regeneration and neuronal function restoration following SCI. The objective of this stem cell therapy development project is to file IND for hESC neuronal therapy derivatives as treatments for SCI to obtain FDA approval for first-in-human studies, and to complete early phase clinical trials designed to test safety and clinical efficacy of hESC neuronal therapy derivatives in treating SCI-resulted paralysis. Clinically-suitable hESC neuronal derivatives will be cGMP manufactured and transplanted into both acute and chronic paraplegic patients with complete SCI. Clinical trials will be designed to evaluate primarily safety in humans as well as provide preliminary evidences of effectiveness for nerve regeneration and motor function improvement that could lead to more definitive clinical efficacy studies. Fulfilling the goal of this project will lead to safe and effective hESC-based regenerative therapies as optimal treatment options for tissue and function restoration following SCI.  The outcome of this project will have a transformative impact on improving the function, wellness, and overall quality of life.

Our Response to CIRM: This CIRM RFA does not require PreIND meeting, part of the goal is to have the meeting and file an IND. San Diego Regenerative Medicine Institute (SDRMI) hESC neuronal & cardiomyocyte therapy derivatives are currently the only available human cell sources with adequate capacity to regenerate neurons & contractile heart muscles, vital for CNS and heart repair in the clinical setting. CIRM are giving CIRM board member applicants preferential treatment, such as they only need to file a IND (does not even matter what kind of IND, if the IND has anything to do with Prop 71, or if they are in CA or not, so long as they connect to somebody in CIRM), we have to have pre-IND meeting with our Prop 71 IND since we do not have any member on board to speak for us, not consistent with Prop 71 equal and fair competition review criteria. CIRM have been withholding Prop 71 from CA human embryonic stem cell (hESC) research and facility, such as deny consideration against Prop 71 for our grant applications targeting for heart and neurological diseases in accordance with Prop 71 pursuant to Prop 71 and consistent with Prop 71 (e.g., TR4-06762; DR2-05339; TR3-05505; RB4-06272). We have all our scientific data ready to file an IND, wait for CIRM to give us lawful Prop 71 fund to do that. We said in the LOI, whenever CIRM is going to dole out Prop 71 in accordance with Prop 71 pursuant to Prop 71 and consistent with Prop 71 to us, whenever we are planning to file an IND immediately. That CIRM continue to deny Prop71 funding for our urgent hESC research & therapy while give COI preferential treatment is telling those patients in need of Prop 71 hESC therapy and treatment to wait because CIRM are embezzling CA stem cell research fund to waste on CIRM board members’ luxury salaries and conflicts of interest and fake science without competition. We said that 3 years ago, said it again 2 years ago, said in ICOC meeting, and said it again in this RFA. It is CIRM board COI members like you have been trying to delay Prop 71 mission.

By the way, my former mentors Dr. Evan Snyder of Sanford Burnham & Dr. Jean Loring of Scripps & others (5) have close connection with Dr. Larry Goldstein & others of UCSD and CIRM president Alan Trounson & his human cloning company ISCO in Carlsbad and majority of CIRM board members such as CIRM vice chair/UC connect CEO Duane Roth & Roth Capital & Biomed Realty (BMR), & have severe conflicts of interest with San Diego Regenerative Medicine Startup. My former mentors and Larry Goldstein are all stem cell center directors and prestigious professors, they have been giving us a hard time in terms of stem cell faculty & resource sharing of Sanford Consortium, using their basic mentor & director duty such as providing reference letter, collaboration, resource coordination, stem cell meeting organization as their bargaining chips for preferential treatment of CIRM funding and public stem cell resources to themselves & their associates. Although we are welcome resource sharing and collaboration of Sanford consortium, my mentors and their institutions had voluntarily withdrawn their supports, therefore, withdrawn their rights to my stem cell research. I am sure they are prestigious professors & directors like the majority of those on CIRM board, should have their integrity not to take the advantage of Regenerative Medicine startup and get preferential treatment for hundreds of millions of CIRM funding & resources using their stem cell center director position and connection with CIRM board members.

---

From: Gil Sambrano [mailto:GSambrano@cirm.ca.gov]
Sent: Friday, March 29, 2013 4:51 PM
To: parsons@SDRMI.org
Subject: CIRM Disease Team LOI

Dear Dr. Parsons:

We have reviewed the LOI submitted in response to RFA 13-01, Disease Team Therapy Development Awards. Unfortunately, your proposal does not meet the eligibility requirements described for this RFA and therefore we cannot accept the LOI. The project was found to not yet be at an eligible and competitive stage of readiness for this RFA. For example, a PreIND meeting has not yet been conducted the outcomes of which are critically important in developing a competitive proposal. The information you provided was carefully reviewed by our clinical development and early translation teams and presented to the CIRM president to ensure a careful consideration of the LOI.

We encourage you to continue the development of this candidate and consider applying to the next Disease Team round.

If you have any questions please feel free to contact me.

Gil

-- 

Gilberto R. Sambrano, Ph.D.

Associate Director, Review

California Institute for Regenerative Medicine

210 King Street

San Francisco, CA 94107

(415) 396-9103

CIRM Embezzle $32 million CA Stem Cell Research Fund to Bank Fake Science in UC and Out of State

CIRM (California Institute for Regenerative Medicine) withhold Prop 71 from CA human embryonic stem cell (hESC) research and facility, such as our grant applications targeting for heart and neurological diseases in accordance with Prop 71 pursuant to Prop 71 and consistent with Prop 71 (e.g., TR4-06762; DR2-05339; TR3-05505; RB4-06272). San Diego Regenerative Medicine Institute (SDRMI) hESC neuronal & cardiomyocyte therapy derivatives are the only human cell sources with adequate capacity to regenerate neurons & contractile heart muscles, vital for CNS and heart repair in the clinical setting. Recent advances and breakthroughs in SDRMI hESC research have overcome some major obstacles in bringing hESC therapy derivatives towards clinical applications. SDRMI & Xcelthera have established human stem cell technology platforms for defined culture systems for derivation and maintenance of clinical-grade pluripotent hESCs (PluriXcel-DCS) and lineage-specific differentiation of pluripotent hESCs by small molecule induction for direct conversion of pluripotent hESCs into neuronal cells or heart muscle cells for developing safe and effective stem cell therapies (PluriXcel-SMI). Such milestone advances and medical innovations in SDRMI & Xcelthera hESC research enable generation of a large supply of high purity clinical-grade hESC neuronal (Xcel-hNuP & Xcel-hNu) & heart (Xcel-hCardP & Xcel-hCM) cell therapy products for treating neurological & heart diseases & injuries. Please go to our websites at http://www.sdrmi.org & http://www.xcelthera.com to see SDRMI & Xcelthera stem cell research breakthrough publications, human stem cell therapy products and technology platforms, and watch videos of hESC heart beats (hESC-derived heart muscle cells) & slideshow of evolution of CNS neuron cells from hESCs by SDRMI & Xcelthera exclusive human stem cell technique PluriXcel-SMI.

On the other hand, CIRM embezzle CA stem cell research fund to conflict of interest in UC and out of state to waste on banking stem cell frauds and scams. Abnormal iPS cells are made from adult skin cells and disease tissues have nothing to do with stem cell research of Prop 71. Anyone in his/her right state of mind would believe such ridiculous fake science that disease tissues would make any stem cells as CIRM press release claimed, which would make CIRM communication officer Kevin McCormack of no moral integrity sound very much like a stem cell con man. Why would CIRM waste ~$32 million taxpayers’ money to have those UC and out of state researchers to collect disease tissues and bank disease cells? CIRM gave $10 M CA bond to Coriell Institute for Medical Research & $16 M more CA bond to Cellular Dynamics International of Jamie Thomson, both company are outside of California. Is it obvious that the only reason they got the multi-millions of awards from California stem cell agency is their connection with somebody on CIRM board, such as CIRM chair Jon Thomas & top officials with these out state company Florida WSCS meeting & NIH director personalized medicine & iPS center director Dr. Rao for banking into CIRM Buck Institute resources. While other CIRM resources so far have been withholding California stem cell research resources & infrastructure built with > $300 millions of state fund, such as Sanford Consortium for Regenerative Medicine & UC Stem Cell Centers, from stem cell research, turning those expensive state stem cell center buildings into few UC professors’ penthouses, visibly vacant of any stem cell research, no recruiting or collaborating or sharing activities with any stem cell research expertise who have demonstrated achievement in the area of pluripotent stem cell & progenitor cell biology & medicine according to Prop 71, wasting state fund and resources enormously.

Nobel Assembly Got Sued for Awarding ISSCR Stem Cell Con Man

We’d like to carry the story on Voice of Regenerative Medicine about FIRST LAW SUIT FILED AGAINST NOBEL PRIZE ORGANIZATION CITING DEFAMATION AND UNFAIR COMPETITION PRACTICES. Yamanaka of International Society for Stem Cell Research (ISSCR) put 4 oncogenes into the skin cells of lab rats, then claimed that he had made the safe adult cell alternate of pluripotent human embryonic stem cells (hESCs) by calling it as the induced pluriptoent stem cells (iPS cells) without any scientific evidence for the long-term stable self-renewal of stem cells by the definition of stem cells. The iPS cell of Yamanaka is more accurately known as the induced pluripotent somatic cell or the artificially reprogrammed adult cell. Although scientific term is mandated to be as accurate as possible, Yamanaka’s iPS cell term could not be any more confusing and far away from the truth. Anyone (not short of list) who had done what Yamanaka did before all had the scientific integrity to call what they had done as cancer studies. The only difference is what Yamanaka did was published in the prestigious top scientific Journal “Cell” (How?) that had been quickly endorsed and followed by a group of prestigious scientists of ISSCR that include the “father of stem cell” Jamie Thomson and Rudy Jaenisch and George Daley of Harvard, and had a committee of big names to campaign for Nobel prize for him with sugar-coated hidden political interest or agenda. The iPS abnormal cell of Yamanaka of ISSCR is a serious stem cell scam or fraud committed by someone who has no scientific integrity, misleading the stem cell community and general public to waste the public and taxpayers’ money enormously. The iPS abnormal cells of Yamanaka of ISSCR have created unfair competition practices for normal stem cell research and have stalled human embryonic stem cell research. Please see our blogs about it, such as “CIRM Embezzle State Fund and Resources to Waste on Induced Adult Stem Cell Scam (CIRM iPS Cell Initiative) Against Prop 71 – ISSCR Stem Cell Conman’s Thick Skin”, “CIRM’s iPS Cell Initiative — The Cloning Saga of ISSCR”, “Human Embryonic Stem Cells: The Most Positive Stem Cells — The Positivity CIRM Not Get”, “Frenzy over Reprogramming — Nobel Prize Condescended to Cooked Stem Cell Fraud”, “CIRM Lucrative RFAs Make Prop71 Stem Cell Research Impossible to Get Lawful Public Funds whereas Give Unlawful Frauds the Green Light”, “iPS Cells or Man-Made Junk”.

Quote from James Watson: “You could sequence 150,000 people with cancer and it’s not going to cure anyone ---”, “most of the experiments we do are irrelevant (to find a cure) ---”.

MEBO International: We wanted to reach out about the newest developments in Chinese researcher Rongxiang Xu's lawsuit against the Nobel Assembly as well as recent statements by James Watson regarding the ineffectiveness of genetic sequencing. Please take a look to see if this is would interest your readers, as both have relevance for the future of regenerative medicine

Human’s Innate Regenerative Ability

After Nobel’s assertion that his lawsuit is frivolous, Xu is seeking clarification on misstatements made in awarding the 2012 Nobel Prize. The suit was filed against the Nobel Assembly to clarify essential scientific details that Dr. Xu believed were misstated in their October 2012 Nobel prize announcement. Errors made in the statements not only discredit Dr. Xu's science (which has illustrated innate regenerative potential), but also involve the health and safety of people worldwide.

Xu is urging the Assembly to distinguish whether or not the human regenerative potential is innate or must be artificially created.

Background

Rongxiang Xu’s work in applied regenerative restoration science has implications in many medical fields, including helping severe burn victims and potentially assisting in the fight against cancer. With James Watson’s recent comments regarding the ineffectiveness of genetic sequencing, the growing need for stem cell research and regenerative medicine has made this topic even more relevant.

For more background on James Watson’s statements and Dr. Xu’s lawsuit:

UT San Diego - “Watson dings genetics, Irish, fellow Nobelist”: http://bit.ly/Yr5WCB

The Scientist - “Snubbed for a Nobel”: http://bit.ly/X96rjG

Sacramento Bee - “Nobel Assembly Attempts to Downplay Lawsuit with Dr. Rongxiang Xu”: http://bit.ly/10eNuw7

You can also learn more at the MEBO International Website or visit the MEBO International Facebook Page.