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Compensation for Human Eggs Approved by Key California Senate Committee, But Not For CIRM Researchers

Posted: June 13, 2013 at 2:11 pm

Legislation that would permit women in
California to be paid for their eggs for scientific research
yesterday cleared a key state Senate committee and is likely headed
for the governor's desk.
The measure by Assemblywoman Susan
Bonilla,
D-Concord, was approved on a 6-1 vote by the Senate Health
Committee
and now goes to the Senate floor. Earlier, it passed the
Assembly on a 54-20 vote.
Some stem cell researchers and other
scientists have chafed under state restrictions that bar compensation
for eggs while that the same time fertility clinics are paying an average of $9,000 a session for eggs, with some prices going as high as $50,000.
However, the legislation will not
affect researchers using grants from the $3 billion California stem
cell agency. The agency's regulations bar compensation for eggs in
the research that it funds. That means that at least a two-tiered
research system would exist in California not to mention another tier
created by federal regulations that differ from both those of the
stem cell agency and those set by the legislation.
CIRM's restrictions are required by
Proposition 71, which created the agency in 2004, and cannot be
changed without a 70 percent vote of the legislature. Bonilla's bill
requires only a majority vote.
Bonilla's legislation is sponsored by
American Society for Reproductive Medicine, the chief industry
group for the largely unregulated fertility industry.
The analysis prepared for yesterday's
committee session summarized Bonilla's arguments for the measure in
this fashion:

“This bill seeks to create equity in
the field of medical research compensation by removing the
prohibition on compensation for women participating in oocyte (egg)
donation for medical research. All other research subjects are
compensated for their time, trouble, and inconvenience involved in
participating in research. AB 926 ensures that women are treated
equally to all other research subjects - allowing them to actively
evaluate their participation in research studies. Unfortunately, the
ban on compensation has had serious unintended consequences. It has
led to a de facto prohibition on women’s reproductive research in
California, adversely impacting the same women that the ban intended
to protect. With few oocytes donated, fertility research and
fertility preservation research has been at a standstill. This
greatly affects women suffering from fertility issues and women
facing cancer who would like to preserve their oocytes.”

A number of organizations are opposed
to the bill including the Center for Genetics and Society in Berkeley
and the Catholic Church. The bill analysis summarized some of the
opposition arguments in this fashion:

“Egg harvesting exposes healthy young
women to multiple synthetic hormones in order to produce many times
the normal number of eggs per cycle. One of the potential harms is
OHSS, which has resulted in hospitalizations and at least a few
documented deaths. These groups state that many experts remain
concerned about the long-term risks of these drugs, especially
their potential impact on infertility and various cancers.
Follow-up research on egg providers, which could establish the
frequency and severity of these adverse outcomes, is widely
recognized to be grossly inadequate.”

In addition to risk and religious
objections, opponents also argue that poor and minority women are
likely to be exploited by enterprises seeking their eggs to resell at
a profit.
No major stem cell research
organizations, including the California stem cell agency, have taken
a position on the bill. The legislation has received little public
attention, although The Sacramento Bee carried an article last March.
Ruha Benjamin, author of "People's Science" and assistant professor at Boston
University
, also wrote about the measure in April on the Huffington
Post
. Benjamin said,
UC Berkeley professor Charis
Thompson
 compares egg
donation to 'other kinds of physically demanding service work,'
arguing for a 'salary negotiation between the state agency (or
relevant employer) and the donor.' This, she contends, is a 'sensible
and dignified recognition of [the donor's] work, time, and effort.'
And instead of refusing compensation to women, Thompson suggests that
we 'direct our efforts to understanding and minimizing' the risks.
“Indeed. Now more than ever, we must
redouble our efforts, because the market in eggs appears to be
expanding from private reproduction to public research, and
increasingly overseas, if the surrogacy
industry
 is any indication of how 'cheaper' women become a
reserve army of bio-labor in less regulated regions.” 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SVuriAz87l0/compensation-for-human-eggs-approved-by.html

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Our Lady of Lourdes Medical Center & The Heart House Participating in Research Study Using Adult Stem Cells for …

Posted: June 12, 2013 at 7:49 pm

Camden, New Jersey (PRWEB) June 12, 2013

Our Lady of Lourdes Medical Center and The Heart House are participating in a clinical study to determine whether a patients own (autologous), adult, stem cells are safe and can relieve chronic chest pain caused by coronary artery disease, as well as increase their ability to walk/exercise.

The RENEW study, sponsored by Baxter Healthcare Corporation and endorsed by the FDA to support a Biologic License Application for investigational CD34+ cell therapy, is a Phase III clinical trial to test the safety and efficacy of CD34+ stem cells. The study is being conducted at only 50 sites in North America and will involve approximately 440 patients.

The Principal Investigator, Vijay Verma, MD, FACC, and Sub-Investigator Andrew Zinn, MD, both interventional cardiologists with Cardiovascular Associates of the Delaware Valley (The Heart House), performed the first procedure at Our Lady of Lourdes Medical Center on April 25, 2013. The patient suffers from severe refractory angina, with two of the three arteries that supply oxygen to the heart completely blocked and is unable to undergo conventional revascularization.

The patient suffers chest pain every day due to the blockages, said Dr. Verma. She has exhausted all other optimal therapies, including angioplasty, bypass surgery and enhanced external counter pulsation (EECP) to relieve the persistent chest pain.

Patients enrolled in the study are randomly assigned to undergo the procedure or receive the standard of care. Patients in the procedure group are blindly randomized to receive either the stem cells or a placebo.

Forty-eight hours prior to the procedure, Dr. Verma conducted Apheresis procedure to selectively withdraw cells from the patients bloodstream. These cells were sent to a special lab where CD34+ cells were extracted and sent back to the hospital for injection into the patients heart. Derived from bone marrow, CD34+ cells are comprised of endothelial progenitor cells, which may be able to regenerate heart tissue and develop into new blood vessels. Previous Phase I & Phase II clinical trials have shown that the administration of the CD34+ cells were safe, and a reduction in chest pain and increased ability to exercise was noted in people with myocardial ischemia, or lack of oxygen flow to the heart tissue.

During the nearly four-hour procedure, Dr. Verma and his team created an electrical map of the patients heart to locate the damaged area they believed might be causing the chest pain. Using a catheter threaded through the patients groin area to the heart, Dr. Verma injected the patients CD34+ stem cells into areas of heart muscle with poor blood circulation. Neither Dr. Verma nor the patient knows if the stem cells or a placebo were injected until after the trial is completed and data has been obtained and evaluated.

We will follow her for the next two years to see whether the injections improve her chest pain and her tolerance to exercise, said Dr. Verma.

To learn if you are eligible to participate in the study, visit http://www.renewstudy.com.

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Bank Your Stem Cells for Future Use

Posted: June 12, 2013 at 7:49 pm

Stem cells, the precursors to other kinds of cells in the human body, promise near-miracle medical treatments such as regenerating organs or repairing nerves.

But stem cell medicine is still in the early stages. Culturing the right kind of cell remains difficult and so far only a few procedures are FDA-approved. Odds are it will be several years before a wide range of ailments can be treated with stem cells.

For those who want to be ready for that day, some companies in the United States are offering people a chance to bank their stem cells for future use. That way when treatments are available, there will be stem cells ready to go that came from the patient's own body, eliminating the issue of rejection of donor cells. Meanwhile, the cells are presumably healthier, as they would have been collected from a younger, disease-free patient.

"With all these amazing advancements in the last few years, there will be stem cell therapies," said Vin Singh, founder and CEO of Grand Forks, N.D.-based Next Healthcare, which offers stem cell banking.

Next Healthcare is not the only bank out there. Other consumer stem cell banks which differ from the banks used by scientific institutions -- include Biolife Cell Bank of Dallas, NeoStem Inc., of New York, BioEden of Austin, LifeBank of Burnaby, British Columbia. There are many more: stem cell banking was a $435 million business in 2012, according to a report from IBISWorld.

Stem cells can become any kind of cell in the body; they are generalists. In the womb, embryonic stem cells turn into the cells that make up the organs, nerves, blood and bone. After birth, these cells exist in a person's body as so-called adult stem cells and can be found in all kinds of tissue as they play an important role in repair.

Certain medical therapies make use of a stem cell's unique ability to transform into other cells. For example, stem cells from umbilical cord blood are used to create healthy blood cells in order to treat certain forms of leukemia and stem cells collected from a patient's cornea are used in some types of corneal transplants. Doctors have used patients' own stem cells to partially rebuild tracheas.

To bank the stem cells, a person visits a doctor's office, where tissue samples are taken. Stem cells can theoretically come from anywhere, but usually a physician will take a small square of skin, a blood sample, a piece of fat via liposuction or even bone marrow. Some companies offer to bank stem cells from children's teeth as they lose them, and many places offer banking blood from the umbilical cords of newborns.

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ACT’s Dr. Robert Lanza to Deliver the Keynote Address at Brigham & Women’s Hospital Regenerative Medicine Center …

Posted: June 12, 2013 at 7:48 pm

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that its chief scientific officer, Robert Lanza, M.D., will be delivering the Keynote Address at the BWH Regenerative Medicine Center Inaugural Symposium, being held at Brigham & Womens Hospital in Boston on June 11. The Symposium will showcase an exciting array of research in regenerative medicine; highlighting the work of both nationally and internationally recognized investigators and that of the rising stars working in this domain. Dr. Lanzas address, titled Pluripotent Stem Cells Moving From Bench to Bedside, will take place at 4 p.m. EDT in the Bornstein Family Amphitheater & Cabot Atrium.

The newly formed Regenerative Medicine Center at Brigham & Womens Hospital is a marriage of stem cell biology with state-of-the-art engineering and nanotechnology, integrating the talents of engineers, physicists and mathematicians with those of biologists and clinicians. BWH investigators are nationally and internationally recognized for their contributions to advances in stem cell, regenerative medicine and tissue engineering research as recipients of prestigious awards, including elected members of numerous scientific and medical organizations. In addition to Dr. Lanzas Keynote Address, the Symposium will include sessions about Pluripotent Stem Cells & Basic Developmental Biology, Adult Stem Cells & Disease and Novel Technologies in Regenerative Medicine.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2012. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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Easy and effective therapy to restore sight: Engineered virus will improve gene therapy for blinding eye diseases

Posted: June 12, 2013 at 7:47 pm

June 12, 2013 Researchers at UC Berkeley have developed an easier and more effective method for inserting genes into eye cells that could greatly expand gene therapy to help restore sight to patients with blinding diseases ranging from inherited defects like retinitis pigmentosa to degenerative illnesses of old age, such as macular degeneration.

Unlike current treatments, the new procedure is quick and surgically non-invasive, and it delivers normal genes to hard-to-reach cells throughout the entire retina.

Over the last six years, several groups have successfully treated people with a rare inherited eye disease by injecting a virus with a normal gene directly into the retina of an eye with a defective gene. Despite the invasive process, the virus with the normal gene was not capable of reaching all the retinal cells that needed fixing.

"Sticking a needle through the retina and injecting the engineered virus behind the retina is a risky surgical procedure," said David Schaffer, professor of chemical and biomolecular engineering and director of the Berkeley Stem Cell Center at UC Berkeley. "But doctors have no choice, because none of the gene delivery viruses can travel all the way through the back of the eye to reach the photoreceptors -- the light sensitive cells that need the therapeutic gene.

"Building upon 14 years of research, we have now created a virus that you just inject into the liquid vitreous humor inside the eye, and it delivers genes to a very difficult-to-reach population of delicate cells in a way that is surgically non-invasive and safe. "It's a 15-minute procedure, and you can likely go home that day."

The engineered virus works far better than current therapies in rodent models of two human degenerative eye diseases, and can penetrate photoreceptor cells in monkeys' eyes, which are like those of humans.

Schaffer said he and his team are now collaborating with physicians to identify the patients most likely to benefit from this gene delivery technique and, after some preclinical development, hope soon to head into clinical trials.

Schaffer and John Flannery, UC Berkeley professor of molecular and cell biology and of optometry, along with colleagues from UC Berkeley's Helen Wills Neuroscience Institute and the Flaum Eye Institute at the University of Rochester in New York, published the results of their study on June 12 in the journal Science Translational Medicine.

Harnessing a benign virus for gene therapy

Three groups of researchers have successfully restored some sight to more than a dozen people with a rare disease called Leber's congenital amaurosis, which leads to complete loss of vision in early adulthood. They achieved this by inserting a corrective gene into adeno-associated viruses (AAV), and injecting these common but benign respiratory viruses directly into the retina. The photoreceptor cells take up the viruses and incorporate the functional gene into their chromosomes to make a critical protein that the defective gene could not, rescuing the photoreceptors and restoring sight.

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Easy and effective therapy to restore sight: Engineered virus will improve gene therapy for blinding eye diseases

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Merksamer Makes Only Bid For Stem Cell Agency Lobbying Contract

Posted: June 12, 2013 at 1:25 pm

Only one of California's lobbying firms
is interested in working for the California stem cell agency – at
least interested enough to put in a bid.
However, that is likely more of a
function of the small size of the contract – $65,000 – and the
entrenched nature of CIRM's existing lobbyist – Nielsen, Merksamer,
Parrinello, Gross & Leoni LLP
– one of the state Capitol's
larger lobbying firms with $5 million in billings last year.
The firm touted its longstanding
connection to the $3 billion agency in its 21-page proposal in
response to a CIRM RFA this spring. The firm has been with CIRM since
2005.
Nielsen Merksamer's proposal also noted
a couple of other interesting aspects of the continuing arrangement.
CIRM will run out of money for new grants in 2017, and Nielsen
Merkasamer said,

“Furthermore, as a premier
legislative advocacy and (Nielsen's italics) ballot measure
law ?rm, Nielsen Merksamer can actively and effectively assist CIRM
as it contemplates returning to the voters for additional funding.”

The proposal also suggested that it can
conceal information that normally would be public record. The firm
said,

“Another unique advantage offered by
Nielsen Merksamer is that, unlike the vast majority of lobbying ?rms,
since we are a full-service law ?rm, our relationships with our
clients are subject to the attorney-client privilege.”

CIRM used such a technique in 2012 and 2008 in matters involving its budget and PR advice.
Nielsen Merksamer also said,

“(N)o one understands CIRM’s 'total
picture' better than Nielsen Merksamer. Not only has Nielsen
Merksamer been representing CIRM before the Legislature for the past
decade, but Nielsen Merksamer was also one of the principal drafters
of the aforementioned Proposition 71—which brought CIRM to life.
The depth of Nielsen Merksamer’s familiarity with, and
understanding of, CIRM’s mission and structure, the challenges it
faces, and the promise it holds simply cannot be matched by any other
legislative advocate.”

The firm said it would not need the
$65,000 offered by CIRM but would charge only $49,200 annually, about the same as
it has been paid for several years. Steve Merksamer and Gene Erbin,
who drafted portions of Proposition 71, would handle most of CIRM's
affairs. John Moffatt and Missy Johnson would also be available.
The firm's proposal outlined several
instances where it successfully killed legislation opposed by CIRM.
You can read about them in their proposal below.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/kTRN6kUuSDk/merksamer-makes-only-bid-for-stem-cell.html

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The Global Stem Cells Group – Video

Posted: June 12, 2013 at 10:44 am


The Global Stem Cells Group
Welcome to the Global Stem Cells Group, a Company positioned to become the worldwide leader in Cellular Medicine. We provide a substantial array of solutions...

By: StemCellsGroup

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Stem cells treatment for avascular necrosis (AVN) in India – Video

Posted: June 12, 2013 at 10:44 am


Stem cells treatment for avascular necrosis (AVN) in India
Stem cell treatment treatment of AVN in India can cure early AVN. AVN is a condition that affects young patients. Often the cause is unknown. It invariably p...

By: ALAMPALLAM VENKATACHALAM

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Mayo puts stem cells to the test on infant’s heart defect

Posted: June 11, 2013 at 5:47 pm

Published 1:43pm Monday, June 10, 2013

ROCHESTER Every year, about 1,000 babies are born in the United States with half a heart a rare defect that requires a series of risky surgeries and, even then, leaves the infants with a strong likelihood that their hearts will wear out prematurely.

Now, the Mayo Clinic has received federal approval for a first-of-its kind clinical study to see if stem cells from the babies own umbilical cords can strengthen their underdeveloped hearts and extend their lives.

If it works, the new technique could buy these children time as scientists scramble for a cure for the congenital defect called hypoplastic left heart syndrome.

The Mayo study, which will begin as soon as 10 eligible candidates can be enrolled, could also pave the way for additional breakthroughs in stem cell treatments that would help the 19,000 children born each year with other heart defects. But for the time being, the doctors at Mayo are keeping their focus on those babies who need the most help now.

We are not here to build an academic career out of science and technology, said Dr. Timothy Nelson, director of Mayos HLHS research program. Were really here to make a difference in childrens lives who are living today with unmet needs.

Christina DeShaw of Clive, Iowa, was pregnant with fraternal twins when she learned during an ultrasound procedure that the left side of her daughters heart was not developing properly.

The world just started spinning, DeShaw said. Our lives were forever changed from that moment on.

DeShaw and her husband, Brad Weitl, sought help from the Mayo Clinic for the baby they named Ava Grace.

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Mayo puts stem cells to the test on infant’s heart defect

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Mayo Clinic First in US to Test Stem Cells in Pediatric Congenital Heart Disease Patients

Posted: June 11, 2013 at 5:47 pm

Released: 6/11/2013 2:00 PM EDT Source Newsroom: Mayo Clinic

June 11, 2013

MULTIMEDIA ALERT: Animation of the surgical procedure as well as audio and video of Drs. Nelson and Burkhart are available for download from the Mayo Clinic News Network.

http://www.mayoclinic.org/news2013-rst/7521.html

Newswise ROCHESTER, Minn. -- Mayo Clinic has announced the first U.S. stem cell clinical trial for pediatric congenital heart disease. The trial aims to determine how stem cells from autologous umbilical cord blood can help children with hypoplastic left heart syndrome (HLHS), a rare defect in which the left side of the heart is critically underdeveloped.

The trial will test the safety and feasibility of delivering a personalized cell-based therapy into the heart of 10 infants affected by HLHS. Today, treatment for babies born with HLHS involves three heart surgeries to redirect blood flow through the heart, or transplantation. The surgeries -- designed to provide adequate blood flow in and out of the heart, allowing the body to receive the oxygen-rich blood it needs -- are typically performed over the first few years of life. For this study, stem cells from newborns with HLHS will be collected from the umbilical cord following birth. The cord blood will be sent to a Mayo Clinic lab for processing, where the stem cells will be separated from the other cells in the blood. The stem cells will then be frozen for preservation. During the babys second surgery for HLHS -- typically performed at 4 to 6 months of age -- the stem cells will be injected into the heart muscle.

We want to see if these stem cells will increase the volume and strength of the heart muscle to give it greater durability and power to pump blood throughout the body, says Harold Burkhart, M.D., a pediatric cardiovascular surgeon with the Mayo Clinic Childrens Center.

About 960 babies are born with hypoplastic left heart syndrome each year in the U.S., the Centers for Disease Control and Prevention estimates. In this syndrome, the left side of the heart cant properly supply blood to the body because the lower left chamber (left ventricle) is too small or, in some cases, may not exist, Dr. Burkhart says. In addition, the valves on the left side of the heart (aortic valve and mitral valve) dont work properly, and the main artery leaving the heart (aorta) is smaller than normal, he says.

The care of these children with HLHS has been continuously improving since the first surgical procedure became available three decades ago, yet cardiac transplantation continues to be the limiting factor for far too many individuals, says Timothy Nelson, M.D., Ph.D., director of the Todd and Karen Wanek Family Program for HLHS in Mayo Clinics Center for Regenerative Medicine. Applying stem cell-based regeneration may offer a viable solution to help these children develop new tissues and grow stronger hearts.

# # # About Mayo Clinic Mayo Clinic is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. For more information, visit http://www.mayoclinic.com and http://www.mayoclinic.org/news.

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