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Category Archives: Stem Cell Therapy
Cryo-Cell International Taps Leader in Stem Cell Therapy to Serve as Chief Scientific Officer
Posted: May 3, 2012 at 3:10 pm
OLDSMAR, Fla., May 3, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Cryo-Cell International, Inc. announced the appointment of Linda Kelley, Ph.D., as chief scientific officer. Dr. Kelley is responsible for overseeing Cryo-Cells state-of-the art laboratory, translational medicine initiatives and quality assurance program at its stem cell and cord blood banking facility in Oldsmar, Florida. She joins the company from the Dana Farber Cancer Institute at Harvard, where she was the director of the Connell OReilly Cell Manipulation Core Facility.
Dr. Kelley is an internationally recognized, cord blood stem cell scientist whose accomplishments have helped expand the scope of stem cell therapies from bone marrow transplantation to the treatment of heart, kidney, brain and other degenerative diseases. She was a member of the board of trustees of the Foundation for Accreditation of Cellular Therapy and chaired its Standards Committee. Dr. Kelley was one of 12 scientists selected by the Institute of Medicine of the National Academies of Science to serve on the panel that advised Congress on how to allocate $80 million in funding to optimally structure a national cord blood stem cell program.
While director of the Cell Therapy Facility at the University of Utah, she established that states first umbilical cord blood collection program that enabled families to donate their childrens cord blood to the national inventory. Dr. Kelley earned graduate and post-doctoral degrees in hematology and immunology at Vanderbilt University in Nashville, Tenn., where she also served as assistant professor in the Department of Medicine.
As a leader in our field, Cryo-Cell is delighted to have someone of Dr. Kelleys caliber directing our laboratory and translational medicine initiatives. Her expertise will ensure that we continue to exceed the industrys quality standards and maintain our tradition of offering clients the absolute best in cord blood, cord tissue, and menstrual stem cell cryopreservation services, said David Portnoy, chairman and co-CEO at Cryo-Cell. Under her guidance, Cryo-Cell will be propelled to the forefront of regenerative medicine.
Kelley replaces Julie Allickson, Ph.D., who is joining the Wake Forest Institute for Regenerative Medicine (WFIRM), where she will manage translational research. WFIRM is led by Anthony Atala, M.D., a Cryo-Cell board member and preeminent stem cell scientist.
The opportunity to work in a cutting-edge facility with a staff that is exceptionally well trained was very attractive to me, said Dr. Kelley. But equally important in my decision to join Cryo-Cell, was the commitment that co-CEOs David and Mark Portnoy have made to support the advancement of regenerative medicine through partnerships with Stanford University and private research facilities. Cryo-Cell is unique among stem cell cryopreservation firms in that regard.
About Cryo-Cell International, Inc. Cryo-Cell International, Inc. was founded in 1989. In 1992, it became the first private cord blood bank in the world to separate and store stem cells. Today, Cryo-Cell has over 240,000 clients worldwide from 87 countries. Cryo-Cell's mission is to provide clients with state-of-the-art stem cell cryopreservation services and support the advancement of regenerative medicine. Cryo-Cell operates in a facility that is compliant with Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP). It is ISO 9001:2008 certified and accredited by the American Association of Blood Banks. Cryo-Cell is a publicly traded company, OTC:QB Markets Group Symbol: CCEL. Expectant parents or healthcare professionals who wish to learn more about cord blood banking and cord blood banking prices may call 1-800-STOR-CELL (1-800-786-7235) or visit http://www.cryo-cell.com/.
Forward-Looking Statement Statements wherein the terms "believes", "intends", "projects", "anticipates", "expects", and similar expressions as used are intended to reflect "forward-looking statements" of the Company. The information contained herein is subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward-looking statements or paragraphs, many of which are outside the control of the Company. These uncertainties and other factors include the success of the Company's global expansion initiatives and product diversification, the Company's actual future ownership stake in future therapies emerging from its collaborative research partnerships, the success related to its IP portfolio, the Company's future competitive position in stem cell innovation, future success of its core business and the competitive impact of public cord blood banking on the Company's business, the Company's ability to minimize future costs to the Company related to R&D initiatives and collaborations and the success of such initiatives and collaborations, the success and enforceability of the Company's menstrual stem cell technology license agreements and umbilical cord blood license agreements and their ability to provide the Company with royalty fees, the ability of the reproductive tissue storage to generate new revenues for the Company and those risks and uncertainties contained in risk factors described in documents the Company files from time to time with the Securities and Exchange Commission, including the most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K filed by the Company. The Company disclaims any obligations to subsequently revise any forward-looking statements to reflect events or circumstances after the date of such statements.
Contact: David Portnoy Cryo-Cell International, Inc. 813-749-2100 dportnoy(at)cryo-cell(dot)com
This article was originally distributed on PRWeb. For the original version including any supplementary images or video, visit http://www.prweb.com/releases/2012/5/prweb9469228.htm
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Cryo-Cell International Taps Leader in Stem Cell Therapy to Serve as Chief Scientific Officer
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A Media Event on Clinical Developments in Gene and Cell Therapy
Posted: May 3, 2012 at 4:11 am
Milwaukee, WI (PRWEB) May 02, 2012
Academic and industry leaders in gene and cell therapy will be featured at a Media Event in Philadelphia, PA on May 15, 2012, immediately preceding the 15th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) on May 16-19, 2012. The event will focus on recent clinical developments in targeted biotherapeutics for various diseases.
Members of the media will also receive complimentary full-access registration to the ASGCT 15th Annual Meeting at the Pennsylvania Convention. To complete your registration to the Media Event and the Annual Meeting, please visit the ASGCT website.
2:00 pm 2:20 pm: Gene and cell-based immunotherapy for cancer Many cancers are known to acquire the ability to suppress anti-tumor immune responses in the host. The genetically modified cells developed and used in this clinical trial are designed to reawaken immune cells that have been suppressed by the leukemia and stimulate the generation of so-called memory T cells, which can provide ongoing protection against recurrence. Although long-term effectiveness of this novel treatment is not yet known, the doctors have found that months after infusion, the new cells had multiplied and continued their seek-and-destroy mission against cancerous cells throughout the patients bodies. The new paradigm provides a tumor-attack roadmap for the treatment of other cancers including lung, myeloma, ovarian cancer and melanoma.
Carl June, MD is currently the Director of Translational Research at the Abramson Cancer Center,, an Investigator of the Abramson Family Cancer Research Institute, and a tenured Professor of Pathology and Laboratory Medicine at the Perelman School of Medicine of the University of Pennsylvania.
2:20 pm 2:30 pm: Question and answer period
2:30 pm 2:50 pm: Gene therapy for hemophilia B Hemophilia B is an X-linked bleeding disorder caused by a deficiency of blood coagulation Factor IX, and patients need to be infused with the newly developed long-acting protein concentrates twice a month. Advances in gene therapy using intravenous infusion of an AAV vector expressing human Factor IX in a clinical trial on hemophilia patients have significantly improved circulation of Factor IX levels that transformed their disease from severe hemophilia to mild hemophilia. Other strategies are also under development that may confer the ability to correct the disease permanently by gene therapy.
Katherine High, MD is the William H. Bennett Professor of Pediatrics at the University of Pennsylvania School of Medicine, an Investigator of the Howard Hughes Medical Institute and Director of the Center for Cellular and Molecular Therapeutics at the Children Hospital of Philadelphia. Dr. High has pioneered safe and effective clinical translation of genetic therapies for inherited disorders including hemophilia B, and she is a Past President of the American Society of Gene and Cell Therapy.
2:50 3:00 pm: Question and answer period
3:00 pm 3:20 pm: Gene and cell-based therapy for severe combined immunodeficiency Severe combined immunodeficiency (ADA-SCID, a.k.a. bubble boy disease) is a rare disorder of immunity and without treatment; children affected with ADA-SCID will succumb to infections within the first two years of life. Over the past years >40 patients have been treated with gene-corrected hematopoietic stem cell transplantation, which has led to the regeneration of immune cells and the reconstitution of immune function in >70% of the patients. While hematopoietic stem cell transplantation from a matched donor remains the therapy of choice for ADA-SCID, the results obtained by the current clinical trials have indicated that gene and cell therapy should be considered as the first treatment option in the absence of a matched donor.
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A Media Event on Clinical Developments in Gene and Cell Therapy
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Study using stem cell therapy shows promise in fight against HIV
Posted: May 2, 2012 at 3:10 pm
Public release date: 1-May-2012 [ | E-mail | Share ]
Contact: Charles Casey charles.casey@ucdmc.ucdavis.edu 916-734-9048 University of California - Davis Health System
UC Davis Health System researchers are a step closer to launching human clinical trials involving the use of an innovative stem cell therapy to fight the virus that causes AIDS.
In a paper published in the May issue of the Journal of Virology, the UC Davis HIV team demonstrated both the safety and efficacy of transplanting anti-HIV stem cells into mice that represent models of infected patients. The technique, which involves replacing the immune system with stem cells engineered with a triple combination of HIV-resistant genes, proved capable of replicating a normally functioning human immune system by protecting and expanding HIV-resistant immune cells. The cells thrived and self-renewed even when challenged with an HIV viral load.
"We envision this as a potential functional cure for patients infected with HIV, giving them the ability to maintain a normal immune system through genetic resistance," said lead author Joseph Anderson, an assistant adjunct professor of internal medicine and a stem cell researcher at the UC Davis Institute for Regenerative Cures. "Ideally, it would be a one-time treatment through which stem cells express HIV-resistant genes, which in turn generate an entire HIV-resistant immune system."
To establish immunity in mice whose immune systems paralleled those of patients with HIV, Anderson and his team genetically modified human blood stem cells, which are responsible for producing the various types of immune cells in the body.
Building on work that members of the team have pursued over the last decade, they developed several anti-HIV genes that were inserted into blood stem cells using standard gene-therapy techniques and viral vectors (viruses that efficiently insert the genes they carry into host cells). The resulting combination vector contained:
a human/rhesus macaque TRIM5 isoform, which disrupts HIV from uncoating in the cytoplasm a CCR5 short hairpin RNA (shRNA), which prevents certain strains of HIV from attaching to target cells a TAR decoy, which stops HIV genes from being expressed inside of the cell by soaking up a critical protein needed for HIV gene expression These engineered blood stem cells, which could be differentiated into normal and functional human immune cells, were introduced into the mice. The goal was to validate whether this experimental treatment would result in an immune system that remained functional, even in the face of an HIV infection, and would halt or slow the progression toward AIDS.
The results were successful on all counts.
"After we challenged transplanted mice with live HIV, we demonstrated that the cells with HIV-resistant genes were protected from infection and survived in the face of a viral challenge, maintaining normal human CD4 levels," said Anderson. CD4+ T-cells are a type of specialized immune cell that HIV attacks and uses to make more copies of HIV.
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Study using stem cell therapy shows promise in fight against HIV
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American CryoStem Announces ACS Laboratories Adipose Tissue and Adult Stem Cell Testing Services
Posted: May 1, 2012 at 2:10 am
RED BANK, NJ--(Marketwire -04/30/12)- American CryoStem Corporation (CRYO.PK - News) announced the launch of its new adipose tissue and adult stem cell testing services to assist physicians involved in tissue engraftment, regenerative medicine procedures and cellular therapies utilizing adult adipose derived stem cells. The new testing services provide physicians an affordable method for self assessment of their procedures and methods to better understand the relationship between tissue quality and engraftment success.
American CryoStem recognizes the need for independent testing services as reinforced by the increasing focus and scrutiny of physician office based tissue laboratories by the US Food and Drug Administration (FDA). The menu of testing services includes full 14 day sterility testing, viability testing, growth assay and additional tests for each selected service. The tests can be ordered individually or in multiples over time and are designed to allow physicians to self evaluate their current methods and performance, or to assess new methods or devices designed to improve procedure and tissue quality. Long term and customized programs are available upon request. Physicians enrolled as a provider of the Company's stem cell storage services can obtain discounts for individual and multi test programs.
"We are very excited about rolling these new services out to our existing providers and all participants in the tissue engraftment, regenerative medicine and cellular therapy markets. We believe that this is the first such program offered commercially and meets a critical need for the advancement of the regenerative and cellular therapy markets," said Anthony Dudzinski, the Company's COO. "Now there is a way for physicians to assess their own performance without the need to overcome the significant costs of purchasing and maintaining their own testing facilities."
The new testing services are offered by ACS Laboratories reflects the Company's increasing branding and commercialization of products and services developed around its proprietary clinical tissue processing and storage methodologies. ACS Laboratory incorporates its proprietary cGMP/cGTP aseptic methods and FDA guidance's into these services to ensure the highest quality and most useful information for physicians.
About American CryoStem: American CryoStem Corporation (CRYO.PK - News) markets clinical processing services and patented products for Adipose (fat) Tissue and Adipose Derived Adult Stem Cells. The Company's clinical processing, patented cell culture media products and cellular preservation platform supports the science and regenerative medicine applications being developed globally. The Company provides the highest quality, clinically processed cells assuring their purity, viability and growth capabilities, while at the same time developing cutting edge applications, therapies and patented laboratory products and services for consumer and commercial applications.
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Dr. Aaron Schimmer Receives the Till and McCulloch Award – Award Lecture to be Presented Today on Drug Screening with …
Posted: May 1, 2012 at 2:10 am
MONTRAL, April 30, 2012 /CNW/ - Canada's most coveted stem cell prize will be awarded to a Stem Cell Network researcher who has used drug screening to find a potential new treatment for a deadly form of cancer.
Dr. Aaron Schimmer, associate professor in the University of Toronto's Department of Medical Biophysics and a clinician-scientist in the Princess Margaret Cancer Program/Ontario Cancer Institute at University Health Network, has received the 2012 Till & McCulloch Award, presented each year by the Stem Cell Network in recognition of the year's most influential peer-reviewed article by a researcher in Canada. Dr. Schimmer will accept the award and present a lecture entitled "Novel therapeutic strategies to target leukemia stem cells" as part of the Till and McCulloch Meetings in Montral at 2 p.m. this afternoon.
In an advance interview, Dr. Schimmer described his findings and their potential as a new drug therapy in the treatment of leukemia.
"When you treat patients with leukemia, you can kill off 99 per cent of their leukemic cells with just about anything, and yet, 80 per cent or more of patients relapse," Schimmer explained. "When we examined this in a really objective way, the question was not how to kill off those bulk cells - we already knew how to do that - but are we really missing a critical component of what we should be targeting?"
Dr. Schimmer and his team eventually found that cutting off the energy production capacity of bulk leukemia cells and leukemia stem cells was a way of treating the disease, and that the compound tigecyclinean FDA-approved antibiotic sometimes used to treat skin and abdominal infectionswas up to the task.
"Tigecycline appeared to work by essentially shutting down the energy supply of the leukemia cells and stem cells," said Dr. Schimmer. "Essentially it is like producing a selective power outage in leukemia cells but not normal cells."
By focusing on FDA-approved drugs, Dr. Schimmer was able to produce results that were quickly translated into clinical trials. Less than two years passed between his initial findings and the commencement of a phase-one clinical triala process that can otherwise take three or four times that long.
"It is incredibly impressive how much progress Dr. Schimmer has made in such a short period of time by using these stem cell screening techniques," said Stem Cell Network Scientific Director Michael Rudnicki. "By identifying drugs which are already approved for human therapies and testing their efficacy in treating diseases such as leukemia, Dr. Schimmer has shaved years off of the clinical trial process. It is likely that his discovery will improve the outcomes for many patients in the near future."
In 2005, the Stem Cell Network established the Till & McCulloch Award in honour of Canadians Drs. James Till and Ernest McCulloch, whose pioneering work established the field of stem cell research. The Award had been granted at the Stem Cell Network's Annual Scientific Meeting, but became part of the Till & McCulloch Meetings this year.
The previous winner was Timothy Caulfield, who was recognized for his global leadership in the field of stem cell ethics.
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Dr. Aaron Schimmer Receives the Till and McCulloch Award - Award Lecture to be Presented Today on Drug Screening with ...
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California Stem Cell Agency Wants to Weaken Financial Disclosure for Execs and Board
Posted: April 29, 2012 at 3:59 pm
The $3 billion California stem cell agency, which is moving to engage the biotech industry ever more closely, is proposing a major weakening of the financial disclosure requirements for its board of directors and executives.
The move comes as the agency is also seeking to raise cash from the private sector to continue the state research effort's existence. CIRM's dimming of transparency runs counter to government trends nationally for more disclosure rather than less, including regulations enacted last year by the NIH.
The proposed changes will be considered next Thursday by the CIRM directors' Governance Subcommittee, which will have public teleconference sites in San Francisco and Irvine and two each in Los Angeles and La Jolla.
Currently CIRM board members and top executives must disclose all their investments and income – in a general way – along with California real property that they hold. Under the changes, disclosures would instead be required only "if the business entity or source of income is of the type to receive grants or other monies from or through the California Institute for Regenerative Medicine." CIRM offered no explanation of what it means by "of the type to receive" funds from the agency.
The proposal further narrows disclosure in connection with income or investments in enterprises that provide facilities or services used by CIRM. With the removal of the requirement for reporting all investments, CIRM's changes also specified disclosure of income and investments connected to business entities (nonprofits are not mentioned) that are engaged in biomedical research or the manufacture of biomedical pharmaceuticals.
The new code would appear to give CIRM directors and executives wide personal latitude in determining what should be disclosed. The current language simply states that "all" investments, etc., must be disclosed. That language originated in the 1974 ballot initiative that created the state disclosure requirements. The initiative's intent was to give the public and interested parties access to key information that would allow them to determine what forces are at work in government and whether conflicts of interests exist – as opposed to simply trusting the assertions of officials without additional substantiation.
The new code also appears to relieve CIRM officials of reporting investment in or income from venture capital or other firms that may be engaged in financing biotech or stem cell enterprises, since the firms do not receive cash from CIRM or engage in biomedical research.
While the code appears to provide more reporting freedom for board members and executives, it also may indirectly impose a burden on them to determine whether any of their investments may involve biomedical research or enterprises that could possibly receive funds from CIRM at some point
Earlier this week, the California Stem Cell Report asked the stem cell agency about such issues. Kevin McCormack, CIRM's new senior director of public communications and patient advocate outreach, replied that the changes were "proposed" by the state Fair Political Practices Commission, which oversees state disclosure laws.
He said the FPPC says agencies "should tailor their disclosure categories to type of work performed by the agency."
McCormack cited as examples the State Board of Education and the state retirement system.
As for the specific changes in CIRM's code, McCormack said,
"Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate."
McCormack did not comment on whether the proposed code would give board members more reporting latitude or whether it relieve them of reporting investments tied to the financing of biotech or stem cell firms. (The text of his response can be found here.)
The California Stem Cell Report is querying the FPPC concerning its policy regarding disclosure codes. CIRM's new code is expected to go before the the full CIRM board in late May. The changes are subject to review by the FPPC and then must formally go through the state administrative law process during which the public can comment and the code modified before final adoption.
Our take? The proposed changes are not in the best interests of CIRM or the people of California. The absence of transparency and disclosure only breeds suspicious speculation of the worst sort. The agency is already burdened by conflicts of interest that are built in by the ballot measure that created it in 2004. Nearly all of the $1.3 billion that CIRM has handed out has gone to institutions linked to CIRM directors. Weakening disclosure at a time when the biotech industry will become more closely tied to CIRM inevitably raises questions about financial linkages – present and future – between CIRM directors and executives and industry. For the past seven years, CIRM directors and staff have been able to comply with
more complete disclosure. They should continue to do so for the life of the agency, which will expire in less than a decade unless it finds additional sources of cash.
Source:
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Text of CIRM Response on the Weakening of Financial Disclosure Requirements
Posted: April 29, 2012 at 3:59 pm
On April 24, the California Stem Cell
Report asked the state stem cell agency about its proposed changes
in its requirements for financial disclosures from its officials.
Here are the key elements from that query with the stem cell agency's
response following.
Report asked the state stem cell agency about its proposed changes
in its requirements for financial disclosures from its officials.
Here are the key elements from that query with the stem cell agency's
response following.
The agency was invited to respond to
the following: "The new code appears
to give discretion to the employee to determine what enterprise is
'the type to receive grants or other monies' from CIRM. Additionally,
it would not appear to require disclosure of an investment with or
income from, for example, Kleiner Perkins, which is a major investor
in iPierian, which holds $7 million in CIRM grants and could well be
a future applicant...(T)he weakening of the code comes at a time when
the agency is moving to cozy up to industry and looking to raise
funds to continue its existence, all of which raises even greater
conflict of interest issues than earlier in CIRM's existence."
the following: "The new code appears
to give discretion to the employee to determine what enterprise is
'the type to receive grants or other monies' from CIRM. Additionally,
it would not appear to require disclosure of an investment with or
income from, for example, Kleiner Perkins, which is a major investor
in iPierian, which holds $7 million in CIRM grants and could well be
a future applicant...(T)he weakening of the code comes at a time when
the agency is moving to cozy up to industry and looking to raise
funds to continue its existence, all of which raises even greater
conflict of interest issues than earlier in CIRM's existence."
Here is the text of the response April
25 from Kevin McCormack, CIRM's new senior director for public
communications and patient advocate outreach.
25 from Kevin McCormack, CIRM's new senior director for public
communications and patient advocate outreach.
"In answer to your question, we
are proposing changes to the Conflict of Interest Code based upon
recommendations from the California Fair Political Practices
Commission (FPPC). The Political Reform Act requires state
agencies like CIRM to review their Conflict of Interest Codes every
two years. The FPPC, which is charged with enforcing the
Political Reform Act, is responsible for reviewing and approving
CIRM's Conflict of Interest Code. In preparation for this
review, CIRM's counsel met with the FPPC staff who suggested the
proposed amendments which are the subject of the upcoming Governance
Subcommittee meeting. The proposed amendments to CIRM's
Conflict of Interest Code are consistent with the FPPC's position
that agencies should tailor their disclosure categories to type of
work performed by the agency. For example, CalPERS's
conflict of interest code requires CalPERS officials to disclose
investments in, and income from, entities that are of the type with
which CalPERS contracts and entities in which funds administered by
CalPERS could be invested. Likewise, the State Board of
Education requires its members to disclose investments, business
positions, and income from a publisher, manufacturer, or vendor of
instructional materials, or services offered to educational
institutions in the State of California and investments, positions of
management and income from any private school in the State of
California. Similar to these codes, the FPPC proposed that
CIRM's Code be tailored to the nature of CIRM's work. Thus,
the FPPC proposed that CIRM require its board members and high-level
employees to disclose investments in, and income from, entities that
are of the type with which CIRM would contract or from which CIRM
could procure goods or services as well as investments in, and income
from, biotech and pharmaceutical companies. Because these
are the types of entities that are likely to create potential
conflicts of interest, we believe the disclosure categories are
appropriate. It is important to remember, however, that
this is a preliminary proposal. CIRM will seek input from
the Governance Subcommittee, the Board, and members of the public
before seeking approval of the amendments."
Source:
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California Stem Cell Agency Wants to Weaken Financial Disclosure for Execs and Board
Posted: April 29, 2012 at 3:56 pm
The $3 billion California stem cell agency, which is moving to engage the biotech industry ever more closely, is proposing a major weakening of the financial disclosure requirements for its board of directors and executives.
The move comes as the agency is also seeking to raise cash from the private sector to continue the state research effort's existence. CIRM's dimming of transparency runs counter to government trends nationally for more disclosure rather than less, including regulations enacted last year by the NIH.
The proposed changes will be considered next Thursday by the CIRM directors' Governance Subcommittee, which will have public teleconference sites in San Francisco and Irvine and two each in Los Angeles and La Jolla.
Currently CIRM board members and top executives must disclose all their investments and income – in a general way – along with California real property that they hold. Under the changes, disclosures would instead be required only "if the business entity or source of income is of the type to receive grants or other monies from or through the California Institute for Regenerative Medicine." CIRM offered no explanation of what it means by "of the type to receive" funds from the agency.
The proposal further narrows disclosure in connection with income or investments in enterprises that provide facilities or services used by CIRM. With the removal of the requirement for reporting all investments, CIRM's changes also specified disclosure of income and investments connected to business entities (nonprofits are not mentioned) that are engaged in biomedical research or the manufacture of biomedical pharmaceuticals.
The new code would appear to give CIRM directors and executives wide personal latitude in determining what should be disclosed. The current language simply states that "all" investments, etc., must be disclosed. That language originated in the 1974 ballot initiative that created the state disclosure requirements. The initiative's intent was to give the public and interested parties access to key information that would allow them to determine what forces are at work in government and whether conflicts of interests exist – as opposed to simply trusting the assertions of officials without additional substantiation.
The new code also appears to relieve CIRM officials of reporting investment in or income from venture capital or other firms that may be engaged in financing biotech or stem cell enterprises, since the firms do not receive cash from CIRM or engage in biomedical research.
While the code appears to provide more reporting freedom for board members and executives, it also may indirectly impose a burden on them to determine whether any of their investments may involve biomedical research or enterprises that could possibly receive funds from CIRM at some point
Earlier this week, the California Stem Cell Report asked the stem cell agency about such issues. Kevin McCormack, CIRM's new senior director of public communications and patient advocate outreach, replied that the changes were "proposed" by the state Fair Political Practices Commission, which oversees state disclosure laws.
He said the FPPC says agencies "should tailor their disclosure categories to type of work performed by the agency."
McCormack cited as examples the State Board of Education and the state retirement system.
As for the specific changes in CIRM's code, McCormack said,
"Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate."
McCormack did not comment on whether the proposed code would give board members more reporting latitude or whether it relieve them of reporting investments tied to the financing of biotech or stem cell firms. (The text of his response can be found here.)
The California Stem Cell Report is querying the FPPC concerning its policy regarding disclosure codes. CIRM's new code is expected to go before the the full CIRM board in late May. The changes are subject to review by the FPPC and then must formally go through the state administrative law process during which the public can comment and the code modified before final adoption.
Our take? The proposed changes are not in the best interests of CIRM or the people of California. The absence of transparency and disclosure only breeds suspicious speculation of the worst sort. The agency is already burdened by conflicts of interest that are built in by the ballot measure that created it in 2004. Nearly all of the $1.3 billion that CIRM has handed out has gone to institutions linked to CIRM directors. Weakening disclosure at a time when the biotech industry will become more closely tied to CIRM inevitably raises questions about financial linkages – present and future – between CIRM directors and executives and industry. For the past seven years, CIRM directors and staff have been able to comply with
more complete disclosure. They should continue to do so for the life of the agency, which will expire in less than a decade unless it finds additional sources of cash.
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Posted in Stem Cells, Stem Cell Therapy
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Text of CIRM Response on the Weakening of Financial Disclosure Requirements
Posted: April 29, 2012 at 3:56 pm
On April 24, the California Stem Cell
Report asked the state stem cell agency about its proposed changes
in its requirements for financial disclosures from its officials.
Here are the key elements from that query with the stem cell agency's
response following.
Report asked the state stem cell agency about its proposed changes
in its requirements for financial disclosures from its officials.
Here are the key elements from that query with the stem cell agency's
response following.
The agency was invited to respond to
the following: "The new code appears
to give discretion to the employee to determine what enterprise is
'the type to receive grants or other monies' from CIRM. Additionally,
it would not appear to require disclosure of an investment with or
income from, for example, Kleiner Perkins, which is a major investor
in iPierian, which holds $7 million in CIRM grants and could well be
a future applicant...(T)he weakening of the code comes at a time when
the agency is moving to cozy up to industry and looking to raise
funds to continue its existence, all of which raises even greater
conflict of interest issues than earlier in CIRM's existence."
the following: "The new code appears
to give discretion to the employee to determine what enterprise is
'the type to receive grants or other monies' from CIRM. Additionally,
it would not appear to require disclosure of an investment with or
income from, for example, Kleiner Perkins, which is a major investor
in iPierian, which holds $7 million in CIRM grants and could well be
a future applicant...(T)he weakening of the code comes at a time when
the agency is moving to cozy up to industry and looking to raise
funds to continue its existence, all of which raises even greater
conflict of interest issues than earlier in CIRM's existence."
Here is the text of the response April
25 from Kevin McCormack, CIRM's new senior director for public
communications and patient advocate outreach.
25 from Kevin McCormack, CIRM's new senior director for public
communications and patient advocate outreach.
"In answer to your question, we
are proposing changes to the Conflict of Interest Code based upon
recommendations from the California Fair Political Practices
Commission (FPPC). The Political Reform Act requires state
agencies like CIRM to review their Conflict of Interest Codes every
two years. The FPPC, which is charged with enforcing the
Political Reform Act, is responsible for reviewing and approving
CIRM's Conflict of Interest Code. In preparation for this
review, CIRM's counsel met with the FPPC staff who suggested the
proposed amendments which are the subject of the upcoming Governance
Subcommittee meeting. The proposed amendments to CIRM's
Conflict of Interest Code are consistent with the FPPC's position
that agencies should tailor their disclosure categories to type of
work performed by the agency. For example, CalPERS's
conflict of interest code requires CalPERS officials to disclose
investments in, and income from, entities that are of the type with
which CalPERS contracts and entities in which funds administered by
CalPERS could be invested. Likewise, the State Board of
Education requires its members to disclose investments, business
positions, and income from a publisher, manufacturer, or vendor of
instructional materials, or services offered to educational
institutions in the State of California and investments, positions of
management and income from any private school in the State of
California. Similar to these codes, the FPPC proposed that
CIRM's Code be tailored to the nature of CIRM's work. Thus,
the FPPC proposed that CIRM require its board members and high-level
employees to disclose investments in, and income from, entities that
are of the type with which CIRM would contract or from which CIRM
could procure goods or services as well as investments in, and income
from, biotech and pharmaceutical companies. Because these
are the types of entities that are likely to create potential
conflicts of interest, we believe the disclosure categories are
appropriate. It is important to remember, however, that
this is a preliminary proposal. CIRM will seek input from
the Governance Subcommittee, the Board, and members of the public
before seeking approval of the amendments."
Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
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Bellevue doctor tests stem-cell cream as anti-aging therapy
Posted: April 28, 2012 at 10:10 am
by JEAN ENERSEN / KING 5 News
KING5.com
Posted on April 27, 2012 at 11:01 PM
A Bellevue doctor is one of only two researchers in the country testing stem cells as an anti-aging treatment.
Working with volunteer patients, Dr. Fredric Stern extracts stem cells with a liposuction-like procedure. The cells are then mixed with a special medium.
"Half is saved cyrogenically for future use and the other half is shipped to the laboratory in Arizona where on that end the stem cells are grown further," Stern said.
The end product goes into a cream called tropoelastin. The hope is that high concentrations of a patient's own stem cells in the cream will boost the skink's ability to repair itself.
If the eye cream proves successful in the eight-week study, the company will also offer a facial cream. Both could be available within a few months.
Stern said he expects the price to be comparable to high-end cosmetic products that typically cost hundreds of dollars.
Stern said the skin treatment is just the beginning. He said wound care is another possible use.
See original here:
Bellevue doctor tests stem-cell cream as anti-aging therapy
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