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
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
(415) 396-9103
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