Patient Movement Forms in Opposition to FDA Position that the Patient’s Own Stem Cells are Drugs

Patient Movement Forms in Opposition to FDA Position that the Patient’s Own Stem Cells are Drugs

A patient movement, called Safe Stem Cells NOW! was formed in response to the FDA’s position that the patient’s own adult stem cells are drugs and should be regulated as such. The patient group believes that this misclassification of adult stem cells will dramatically slow the availability of therapies without adding any significant patient safety.

At 71 years of age there is little interest on my part or anyone else’s to opt for lung transplants. I think this is disgraceful for our FDA to prohibit the use of autologous stem cells except in a very narrow concept so that people are forced to seek relief outside the USA

Broomfield, Colorado (PRWEB) April 9, 2009 — The American Stem Cell Therapy Association (ASTCA) announced today the on-line publication of its patient web-site, www.safestemcells.org, which reflects the activities and opinions of patients driving the Safe Stem Cells NOW! movement. The patient movement was formed in response to the FDA’s position that the patient’s own adult stem cells are drugs and should be regulated as such. The patient group believes that this misclassification of adult stem cells will dramatically slow the availability of therapies without adding any significant patient safety.

Adult stem cells in culture

Barbara Hanson, the co-founder of www.stemcellpioneers.com, stated “Adult stem cells are cells from our own body. They are very safe. There are no moral or ethical issues. They are safer than taking aspirin and yet the FDA has classified our own stem cells as drugs that require regulation. This means that prolonged investigations, including lengthy clinical trials, will be required for each and every disease and application that adult stem cells could be used for. This could take years and years. It smells of big pharma to me and many others.”

A critical initiative for the ASCTA and the Safe Stem Cells NOW! movement is to bring public awareness to the FDA’s position so consumers, and those who stand to benefit from safe stem cell therapies, have the opportunity to be heard. “We get letters and calls every day from people suffering from a variety of conditions and diseases that have no known cure who are eager to access stem cell therapies.”, Hanson adds. “Many of them are forced to look outside the U.S. for treatment, which involves prohibitive travel and procedure costs.”

One of those patients is Beverly Lessard, a 71-year-old patient from Florida, who has been diagnosed with end stage emphysema. Her late-stage condition prohibits extensive travel and the estimated cost of $12,000 to $50,000 is unaffordable. “At 71 years of age there is little interest on my part or anyone else’s to opt for lung transplants. I think this is disgraceful for our FDA to prohibit the use of autologous stem cells except in a very narrow concept so that people are forced to seek relief outside the USA,” wrote Lessard.

Adult stem cells are ready for early clinical use now and can be processed with the same techniques commonly used in existing in-vitro fertilization labs. “Classifying them as drugs will not add to patient safety, but it will delay treatment to patients who don’t have 1-2 years to wait, let alone 5-7 years,” stated Christopher J. Centeno, M.D., a founding physician member of ASCTA. “ASCTA has established lab guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors,” continued Dr. Centeno.

Adult stem cells are different from embryonic stem cells. Adult stem cells are found in the human body in various tissues. In order to obtain enough to treat a condition or disease, they often need to be cultured, similar to today’s fertility treatments. Adult stem cells have undergone much more research than embryonic stem cells and thus are closer to real world treatments. These adult stem cells are taken from the patient’s own body (autologous) and ASCTA believes that they are therefore safest for use in treating patients.

About Safe Stem Cells Now!
The Safe Stem Cells NOW! Movement was started by the American Stem Cell Therapy Association and driven by its patient members. The movement’s goal is to inform patients and physicians that their ability to access safe stem cell treatment is being heavily restricted by pharmaceutical industry agendas and by the FDA. For more information, visit www.safestemcells.org.

About ASCTA
The ASCTA is a physician group comprised of various medical and surgical specialties whose goal is to bring safe stem cell therapy to patients by establishing laboratory and clinical guidelines. Christopher Centeno, M.D. is a board certified pain management specialist in Colorado who utilizes The Regenexx Procedure, an innovative adult stem cell therapy that helps patients avoid the need for more invasive orthopedic surgery. Dr. Centeno has published numerous medical research papers on the clinical application of adult mesenchymal stem cells. For more information, visit www.stemcelldocs.org.

MEDIA CONTACT:
Holly Hamann
media (at) stemcelldocs (dot) org

via Patient Movement Forms in Opposition to FDA Position that the Patient’s Own Stem Cells are Drugs.

Stem Cell Breakthrough May Lead to MS Treatments – Forbes.com

Now all they have to do is resolve the cancerous tumors issues that embryonic stem cells turn into….and address the associated transplant rejection that requires immunosuppressive drugs for life.  OR…they can go to any of the 5 stem cell treatment clinics around the world that use adult stem cells to make MS sufferers symptom free for years.  Are they once again missing the forest for the trees? Yes. -dg

Map of MS prevalence throughout the world

Stem Cell Breakthrough May Lead to MS Treatments

04.08.09, 08:00 PM EDT

Efforts produce human cells that might someday help repair damaged nerves

THURSDAY, April 9 (HealthDay News) — U.S. scientists say they’ve coaxed human embryonic stem cells into generating cells that might someday be used to repair nerves damaged by multiple sclerosis.

The researchers pushed the stem cells to grow into critical nervous system support cells called oligodendrocytes, according to a report released Thursday.

Oligodendrocytes produce the myelin sheath that surrounds nerve fibers like wire insulation. The findings represent an important step toward embryonic stem cell-based therapies in general, experts say, and also for cell-based therapies for myelination disorders such as MS in particular. At the very least, the findings should lead to a laboratory model of the illness’ pathology.

“They are definitely laying the groundwork for being able to apply these cells in terms of a therapeutic application,” said Timothy Coetzee, executive director of Fast Forward, a wholly-owned subsidiary of the National Multiple Sclerosis Society, which partially funded the study.

Yet at the same time, he added, “It illustrated for me the critical importance of not assuming that because you can do something with a mouse cell, that a human cell is going to behave in the same manner.”

The research was published in t…

via Stem Cell Breakthrough May Lead to MS Treatments – Forbes.com.

Obama Assassinates Any Hope of Stem Cell Treatments in US (with Exec Order 13505)

On 20 June 2007, President George W Bush enacted Executive Order 13435:

…so that the potential of pluripotent stem cells can be explored without violating human dignity or demeaning human life:

Section 1. Research on Alternative Sources of Pluripotent Stem Cells.

(1a) …shall conduct and support research…of stem cells that are…derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus.

(1b-ii) prioritizes research with the greatest potential for clinical benefit;

To read Executive Order 13435 in it’s entirety:

http://repairstemcell.wordpress.com/2009/04/09/executive-order-13435-expanding-approved-stem-cell-lines-in-ethically-responsible-ways/

On 9 March 2009, President Obama revoked Executive Order 13435; by Executive Order 13505:

Sec. 4.  General Provisions.  (b)  Executive Order 13435 of June 20, 2007…IS REVOKED.

To read Executive Order 13505 in it’s entirety:

http://repairstemcell.wordpress.com/2009/04/09/executive-order-13505-of-march-9-2009-removing-barriers-to-responsible-scientific-research-involving-human-stem-cells/

To make it clearer, here is what this all means:

Obama effectively revoked research of stem cells that are non-embryonic and revoked the prioritization of research with the greatest potential for clinical benefit.

With this one unpublicized action, which was not covered by any significant media source, Obama assassinated any hope of Stem Cell Treatments in US for at least 10 years.  Is it coincidence that this happened just when the US was waking up to the benefits of ASC and iPSC and their ability to treat illnesses?

Some may argue that the NIH has 120 days from March 9^th to “issue new NIH guidance on such research” but there are at least two problems with this argument:

1.  Obama effectively limits the power of the NIH by mandating the guidelines be “consistent with this order.”

2.  The FDA’s position is: adult stem cells are drugs, subject to FDA regulation and requiring clinical trials.

http://repairstemcell.wordpress.com/2009/03/27/fda-part-5-adult-stem-cells-are-a-drug/

You can NOT get adult stem cells in the US today even if they are from your own body.  By FDA definition, you can only get drugs derived from stem cells and seeing as how the typical drug development process takes 7-12 years and ½ a billion dollars…

I wouldn’t hold your breath.

Executive Order 13435 – Expanding Approved Stem Cell Lines in Ethically Responsible Ways

Friday, June 22, 2007

Part III

The President

Executive Order 13435-Expanding

Approved Stem Cell Lines in Ethically Responsible Ways

Presidential Documents

34591

Federal Register

Vol. 72, No. 120

Friday, June 22, 2007

Title 3-

The President

Executive Order 13435 of June 20, 2007

Expanding Approved Stem Cell Lines in Ethically

Responsible Ways

By the authority vested in me as President by the Constitution and the

laws of the United States of America, and to provide leadership with respect

to research on pluripotent stem cells derived by ethically responsible techniques

so that the potential of pluripotent stem cells can be explored without

violating human dignity or demeaning human life, it is hereby ordered

as follows:

Section 1. Research on Alternative Sources of Pluripotent Stem Cells. (a)

The Secretary of Health and Human Services (Secretary) shall conduct and

support research on the isolation, derivation, production, and testing of

stem cells that are capable of producing all or almost all of the cell types

of the developing body and may result in improved understanding of or

treatments for diseases and other adverse health conditions, but are derived

without creating a human embryo for research purposes or destroying, discarding,

or subjecting to harm a human embryo or fetus.

(b) Within 90 days of this order, the Secretary, after such consultation

with the Director of the National Institutes of Health (Director), shall issue

a plan, including such mechanisms as requests for proposals, requests for

applications, program announcements and other appropriate means, to implement

subsection (a) of this section, that:

(i) specifies and reflects a determination of the extent to which specific

techniques may require additional basic or animal research to ensure

that any research involving human cells using these techniques is clearly

consistent with the standards established under this order and applicable

law;

(ii) prioritizes research with the greatest potential for clinical benefit;

(iii) takes into account techniques outlined by the President’s Council

on Bioethics, and any other appropriate techniques and research, provided

they clearly meet the standard set forth in subsection (a) of this section;

(iv) renames the ”Human Embryonic Stem Cell Registry” the ”Human

Pluripotent Stem Cell Registry;” and

(v) adds to the registry new human pluripotent stem cell lines that clearly

meet the standard set forth in subsection (a) of this section.

(c) Not later than December 31 of each year, the Secretary shall report

to the President on the activities carried out under this order during the

past fiscal year, including a description of the research carried out or supported

by the Department of Health and Human Services, including the

National Institutes of Health, and other developments in the science of

pluripotent stem cells not derived from human embryos.

Sec. 2. Policy. The activities undertaken and supported by and under the

direction of the Secretary shall be clearly consistent with the following

policies and principles:

(a) the purposes of this order are (i) to direct the Department of Health

and Human Services, including the National Institutes of Health, to intensify

peer reviewed research that may result in improved understanding of or

treatments for diseases and other adverse health conditions, and (ii) to

promote the derivation of human pluripotent stem cell lines from a variety

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of alternative sources while clearly meeting the standard set forth in section

1(a) of this order;

(b) it is critical to establish moral and ethical boundaries to allow the

Nation to move forward vigorously with medical research, while also maintaining

the highest ethical standards and respecting human life and human

dignity;

(c) the destruction of nascent life for research violates the principle that

no life should be used as a mere means for achieving the medical benefit

of another;

(d) human embryos and fetuses, as living members of the human species,

are not raw materials to be exploited or commodities to be bought and

sold; and

(e) the Federal Government has a duty to exercise responsible stewardship

of taxpayer funds, both supporting important medical research and respecting

ethical and moral boundaries.

Sec. 3. Interpretation of this Order. (a) For purposes of this order, the

term ”human embryo” shall mean any organism, not protected as a human

subject under 45 CFR 46 as of the date of this order, that is derived by

fertilization, parthenogenesis, cloning, or any other means from one or more

human gametes or human diploid cells.

(b) For purposes of this order, the term ”subjecting to harm a human embryo”

shall mean subjecting such an embryo to risk of injury or death greater

than that allowed for research on fetuses in utero under 45 CFR 46.204(b)

and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b))

as of the date of this order.

(c) Nothing in this order shall be construed to affect any policy, guideline,

or regulation regarding embryonic stem cell research, human cloning by

somatic cell nuclear transfer, or any other research not specifically authorized

by this order, or to forbid the use of existing stem cell lines deemed eligible

for other federally funded research in accordance with the presidential policy

decision of August 9, 2001, for research specifically authorized by this

order.

Sec. 4. General Provisions. (a) This order shall be implemented consistent

with applicable law and subject to the availability of appropriations.

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(b) This order is not intended to, and does not, create any right, benefit,

or privilege, substantive or procedural, enforceable at law or in equity,

by any party against the United States, its departments, agencies, or entities,

its officers, employees, or agents, or any other person.

THE WHITE HOUSE,

June 20, 2007.

Executive Order 13505 of March 9, 2009 – Removing Barriers to Responsible Scientific Research Involving Human Stem Cells

Wednesday, March 11, 2009

Part IV

The President

Executive Order 13505-Removing Barriers to Responsible Scientific Research Involving Human Stem Cells

Memorandum of March 9, 2009-

Presidential Signing Statements

Memorandum of March 9, 2009-

Scientific Integrity

Presidential Documents

10667

Federal Register

Vol. 74, No. 46

Wednesday, March 11, 2009

Title 3-

The President

Executive Order 13505 of March 9, 2009

Removing Barriers to Responsible Scientific Research Involving

Human Stem Cells

By the authority vested in me as President by the Constitution and the

laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. Research involving human embryonic stem cells and human

non-embryonic stem cells has the potential to lead to better understanding

and treatment of many disabling diseases and conditions. Advances over

the past decade in this promising scientific field have been encouraging,

leading to broad agreement in the scientific community that the research

should be supported by Federal funds.

For the past 8 years, the authority of the Department of Health and Human

Services, including the National Institutes of Health (NIH), to fund and

conduct human embryonic stem cell research has been limited by Presidential

actions. The purpose of this order is to remove these limitations on scientific

inquiry, to expand NIH support for the exploration of human stem cell

research, and in so doing to enhance the contribution of America’s scientists

to important new discoveries and new therapies for the benefit of humankind.

Sec. 2. Research. The Secretary of Health and Human Services (Secretary),

through the Director of NIH, may support and conduct responsible, scientifically

worthy human stem cell research, including human embryonic stem

cell research, to the extent permitted by law.

Sec. 3. Guidance. Within 120 days from the date of this order, the Secretary,

through the Director of NIH, shall review existing NIH guidance and other

widely recognized guidelines on human stem cell research, including provisions

establishing appropriate safeguards, and issue new NIH guidance on

such research that is consistent with this order. The Secretary, through

NIH, shall review and update such guidance periodically, as appropriate.

Sec. 4. General Provisions. (a) This order shall be implemented consistent

with applicable law and subject to the availability of appropriations.

(b) Nothing in this order shall be construed to impair or otherwise affect:

(i) authority granted by law to an executive department, agency, or

the head thereof; or

(ii) functions of the Director of the Office of Management and Budget

relating to budgetary, administrative, or legislative proposals.

(c) This order is not intended to, and does not, create any right or benefit,

substantive or procedural, enforceable at law or in equity, by any party

against the United States, its departments, agencies, or entities, its officers,

employees, or agents, or any other person.

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Sec. 5. Revocations. (a) The Presidential statement of August 9, 2001, limiting

Federal funding for research involving human embryonic stem cells, shall

have no further effect as a statement of governmental policy.

(b) Executive Order 13435 of June 20, 2007, which supplements the August

9, 2001, statement on human embryonic stem cell research, is revoked.

THE WHITE HOUSE,

March 9, 2009.

Yale Daily News – Yale gets stem cell grants

Yale gets stem cell grants

Florence Dethy, Published Wednesday, April 8, 2009

The economy may be down, but for 12 Yale researchers, things are looking up.

A dozen Yale researchers have received $3.9 million in grant funding for research on human embryonic stem cells, The Connecticut Department of Health announced April 1st.

Indeed, after weathering federal cuts to research under former President George W. Bush ’68, stem cell research may be on the rise nationally, though Yale stem cell researchers say they have faring well for some time. On March 9 President Barack Obama retracted the federal stem cell ban enacted. While the repeal will open up a significant new source of federal funding, researchers interviewed said, they added that at Yale they have been benefiting for four years from a 2005 Connecticut law designed specifically to circumvent the federal ban.

via Yale Daily News – Yale gets stem cell grants.

Obama Withdraws Funding for Stem Cell Research CONTRADICTING His Own Speeches!

Just wanted to add one more small media outlet that covered this article and saw the significance of it.

“Obama Assasinates any Hope of Stem Cell Treatments in US

THIS IS THE MOST IMPORTANT ARTICLE OF THE LAST 6 MONTHS!! and I can’t even believe it!!
————————————————–
Just when the US was waking up to the benefits of ASC and iPSC and their ability to treat illnesses…
OBAMA PULLS FUNDING FOR BOTH ADULT & INDUCED PLURIPOTENT STEM CELLS!!!
————————————————–

EMBRYONIC STEM CELLS = ZERO TREATMENTS FOR ZERO DISEASE

ADULT STEM CELLS = 120+ TREATMENTS FOR 120+ DISEASES

INDUCED PLURIPOTENT STEM CELLS = LIKELY ALL OF THE BENEFITS OF ADULT & EMBRYONIC PUT TOGETHER.”

http://repairstemcell.wordpress.com/2009/03/13/obama-assasinates-any-hope-of-stem-cell-treatments-in-us/