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Category Archives: Stem Cell Therapy

California Stem Cell Merger: Capricor and Niles Therapeutics

Posted: July 10, 2013 at 11:52 am

Capricor, Inc., a Beverly Hills company
benefiting from $27 million from the California stem cell agency,
this week announced that it is merging with Niles Therapeutic, Inc.,
of San Mateo.
Linda Marban
Capricor photo
The Capricor story and its treatment
for heart disease have been highlighted (see here and here) by the $3
billion state research agency, which is partially funding a clinical
trial for the firm. The firm sprang from work by Eduardo Marban of
Cedars-Sinai in Los Angeles, one of Capricor's founders. He received
$6.9 million for his early and current work. Capricor was awarded
$19.8 million more.
Capricor, a privately held firm, and
the publicly traded Niles announced on Monday that they were merging.
The new company will be known as Capricor Therapeutics, Inc., and will
be based in San Mateo.
The new firm will be publicly traded
with Capricor CEO Linda Marban as the new CEO.
The new board of directors will have
two members from Niles and seven from Capricor, including its
executive chairman, Frank Litvack, who was an unsuccessful candidate for chairman of the stem cell agency board in 2011.
The merger press release said that the
new company “should
have better access to capital, more potential for steady pipeline
development and more risk diversification."
On completion of the merger, a joint
press release said,

“Nile
will issue to Capricor stockholders shares of Nile common stock such
that Capricor stockholders will own approximately 90% of the combined
company's outstanding shares, and Nile stockholders will own
approximately 10%, calculated in each case on a fully-diluted basis
assuming the issuance of shares underlying options and warrants.
Options of Capricor will be assumed by Nile and become options to
acquire stock of Nile.”

Linda Marban said,

"Capricor's
and Nile's product portfolios complement each other well, as our
therapies will address both the underlying causes and debilitating
effects of heart disease. Capricor's CDCs are allogeneic cardiac
derived stem cells that aim to attenuate and potentially improve
damage to the heart that can result in heart failure, while Nile's
cenderitide is intended to treat patients following hospital
discharge from an acute episode of heart failure."

Niles' stock price stood at $0.04
recently. Its 52 week high was $0.20 and the 52-week low was $0.02.

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Stem Cell Therapy for Knee Pain: Safer than Surgery

Posted: July 10, 2013 at 3:41 am

TAMPA, Fla., July 9, 2013 /PRNewswire/ -- Stem Cell Therapy for knee joint pain has been involved in multiple clinical trials worldwide. In the United States trials for knee arthritis and back pain with degenerative disc disease have undergone safety trials and phase studies for effectiveness. The safety profile for stem cell therapy in joints has been proven. Adverse effects are not seen as related to the stem cells. These studies were conducted with allogenic (other people's) stem cells. Naturally, if using your own stem cells, the issues which may be raised from someone else's stem cells is not a concern, and are therefore even safer. There are no immune rejection issues or communicable diseases that can be obtained by using your own cells.

Stem Cell Therapy for joints also do not carry surgical risks such as anesthesia, there is no greater risk for other postoperative complications such as blood clots, infections, or need for revision surgery if it is unsuccessful. Dr. Dennis Lox, a Regenerative and Sports Medicine physician in the Tampa Bay, Florida area (www.drlox.com), comments, "Surgery for joint replacement does carry some significant risks, as this is a highly invasive surgery. Knee and other joint replacement surgery consent forms do include the complication of death. More common problems are infection and blood clots. Stem Cell Therapy injections for joints are no more difficult than injecting cortisone into the knee," states Dr. Lox."There is preparation involved to get to that point, however the injection can be a simple, same-day, office-based procedure."

Dr. Lox notes, "Stem Cell Therapy for joint repair has been used for acute and chronic injuries, knee meniscal tears, loss of knee joint cartilage, and to stop the progression of degenerative arthritis. Even avascular necrosis (AVN) or osteonecrosis has been treated with Stem Cell Therapy. The secondary arthritis from joint collapse in avascular necrosis (AVN) can be significant leading to knee joint replacement. The useof stem cells is becoming a more common alternative to joint replacement."

Dr. Lox further notes, "Some patients may have already had one knee joint replaced with a bad outcome, and wish to avoid a second knee replacement. Others may not be healthy enough. Some medical disorders such as bad hear ailments may preclude having a knee replacement. In these cases, having a regenerative medicine procedure is an attractive, conservative option. Patients who are not medically suited for joint or knee replacement are generally good candidates for Stem Cell Therapy. The pursuit of conservative options in patients who wish to avoid surgery for joint disorders, may find Stem Cell Therapy as an attractive alternative."

About Dr. Dennis Lox Dr. Lox practices in the Tampa Bay Florida area. Dr. Lox is a Sports and Regenerative Medicine Physician, who specializes in the use of regenerative and restorative medicine to assist in treating athletic and arthritis conditions. Dr. Lox may be reached at (727) 462-5582 or visit Drlox.com.

http://www.drlox.com

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HIV Clinical Trial Hailed by California Stem Cell Agency

Posted: July 9, 2013 at 4:03 pm

The
California stem cell agency today scored what it called an “important
milestone” with the announcement of the start of a clinical trial
involving a therapy to help protect persons infected with HIV from
the effects of the virus.
The
trial is partially funded from a $20 million award from the stem cell
agency, which is known as CIRM, to researchers
at UCLA and Calimmune, a Tucson, Az.,
company. Calimmune's share of the award was $8.2 million.
Alan
Trounson, president of the $3 billion state agency, said in a
statement,

“CIRM
funding of this Phase l/ll trial is an important milestone for us.
One of our goals is to support research that moves the most promising
science out of the lab and into clinical trials in people. To be able
to do that with a disease as devastating as HIV/AIDS highlights the
importance of our funding and the potential impact it could have on
the health of people around the world.”

The
trial was announced by Calimmune this morning. The company said,

“The
first patient has begun treatment in a Phase I/II clinical trial
designed to determine whether a pioneering genetic medicine approach
can help to protect individuals infected with HIV from the effects of
the virus. The study, “Safety
Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1
Infection,”
utilizes a gene medicine called Cal-1, developed in the lab of Nobel
Laureate Dr. David
Baltimore and
by Calimmune.”

Baltimore
served on the CIRM board from 2004 until June 6, 2007. He resigned
from the board about
18 months before the application process began for the grant round
that ultimately funded Calimmune, a company he helped to found. He is currently chairman of the Calimmune board. 
Asked
for comment, Jeff Sheehy, a member of the CIRM governing
board and communications director for AIDS research at UC San
Francisco, said,

"This
trial will hopefully offer several important insights into the safety
and feasibility of genetically modifying blood forming stem cells in
an HIV patient as a potential therapy.  We are very early in
this research, and with this Phase I trial's goal of establishing
safety and the risks involved, I applaud the courage and altruism
demonstrated by the patients who are willing to participate in this
study."

The Calimmune
press release said
the principal investigators on the clinical trial are Ron
Mitsayasu of
UCLA and Jacob
P. Lalezari of Quest
Clinical Research of
San Francisco. Quest is currently soliciting patients for the
clinical trial as well as UCLA. (Persons interested in participating
in the trial can find email contacts at
this website.
Twelve are needed.)
The
principal investigators on the CIRM award are Irvin Chen of
UCLA and Geoff Symonds of Calimmune.  

Here are links to the CIRM press release on the subject and the agency's blog item.

(An earlier version of this story did not include the fact that Calimmune's share of the CIRM award was $8.2 million or the links to the agency press release and blog.)

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Purtier NZ Live Stem Cell Therapy presented by Dr Chen – Video

Posted: July 8, 2013 at 10:45 pm


Purtier NZ Live Stem Cell Therapy presented by Dr Chen
For Live demo and discussion: Call John 90036287 / Daphne 91455217.

By: petty joy

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Purtier NZ Live Stem Cell Therapy presented by Dr Chen - Video

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6 things you need to know about stem cell therapy

Posted: July 8, 2013 at 10:45 pm

by Buena Bernal Posted on 07/06/2013 9:06 PM |Updated 07/08/2013 2:15 PM

DOH ON STEM CELL. (Left) Health Secretary Enrique Ona and (right) FDA Director Kenneth Hartigan-Go talks to Rappler about stem cell therapy. Photos by Rappler/Naoki Mengua

MANILA, Philippines (UPDATED) Rappler talked to Department of Health (DOH) Secretary Enrique Ona and Food and Drug Administration (FDA) Director Kenneth Hartigan-Go to clarify the governments stance on stem cell therapy.

Stem cell therapy or regenerative medicine is a medical intervention that uses the bodys repair cells to substitute old cells. It is done for medical and aesthetic purposes that are still being investigated, according to the health secretary.

Asked why the treatment was allowed in the market despite no definitive curative and preventive benefits, FDA's Hartigan-Go said authorities never allowed the treatment to begin with.

Its just there. Now, the DOH under Secretary Ona's leadership took action," he said.

(READ: DOH: Stem cell therapy not yet proven to be curative)

On March 18, the DOH issued the rules and regulations for the accreditation of health facilities engaging in human stem cell and cell-based or cellular therapies in the Philippines.

The FDA has also released a circular on Monday, Jully 8, regarding the guidelines on registering stem cell-based products. The circular covers all products with a "claim, label, or poster" that says stem cells.

(READ: FDA Circular: Registration of Stem Cell-Based Products)

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6 things you need to know about stem cell therapy

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Eggs and Cash: Stem Cell Agency Considering Easing Restrictions on Stem Cell Lines Derived Using Payments

Posted: July 7, 2013 at 10:12 pm

The California stem cell agency is
moving to remove an absolute ban on use of stem cell lines derived
from eggs from women who have been paid to provide them.
The action comes as state legislation
is headed for Gov. Jerry Brown's desk that would permit payments for
eggs to be used in research that is not funded by the agency. The measure (AB926) would not alter the separate ban on egg payments
involving research funded by the $3 billion stem cell agency.
Under a proposal that will come before the agency's standards group July 24, CIRM's governing board could
approve the use of stem cell lines derived as a result of payment to
women. Board action would be based on whether stem cell lines would
“advance CIRM's mission” and would follow a staff evaluation
involving scientific and ethical issues.
Over recent years, stem cell
researchers around the country have reported that they are not able
to obtain sufficient eggs without payment. And earlier this year,
paid egg providers were used in research in Oregon that cloned human stem cells, a feat that researchers have struggled with for years.
A CIRM staff report said that the
Oregon research has “generated scientific interest among CIRM
grantees and the desire to utilize derived SCNT lines. CIRM’s
current policy prohibits the use of the (Oregon) SCNT lines because
oocyte donors were financially compensated. CIRM requests the Medical
and Ethical Standards Working Group (SWG) revaluate this prohibition
with regard to CIRM grantees ability to utilize the resulting lines
in light of recent scientific and policy developments.”
Last month, the California Stem Cell
Report queried the agency concerning earlier, sketchy information onthe CIRM blog about a possible change in its compensation rules. We
asked whether the agency was considering “sidestepping” the ban
on compensation. Kevin McCormack, a CIRM spokesman, said, “No, not
at all.” He said it would be premature to elaborate until a firm
proposal was ready.
The staff proposal to be considered on
July 24 said,

“Proposition 71’s 'prohibition on
compensation' compels the ICOC(the agency's governing board) to adopt
standards 'prohibiting compensation to research donors.' This
requirement has been consistently interpreted to prohibit the use of
CIRM funds to financially compensate oocyte (or other cell or tissue)
donors. In 2006, this interpretation was extended to exclude from
use, in CIRM-funded research, any stem cell line where research
donors were financially compensated, even if the derivation was done
without the use of CIRM funds. Proposition 71, however, does not
compel the ICOC (the agency's governing board) to prohibit the use of
stem cell lines where financial compensation is provided to the
oocyte donors, provided that CIRM funds are not used to compensate
the donors or derive the lines.”

The July 24 meeting will be held in San
Francisco. No remote teleconference locations have been announced.  If approved, the changes would likely be considered July 25 by the full agency board.

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California Legislation Removing Ban on Payments for Eggs for Research Heads to Governor

Posted: July 7, 2013 at 8:40 pm

Legislation to allow women in
California to be paid for their eggs for scientific research is on
its way to Gov. Jerry Brown following final legislative approval last
week.
Sponsors of the bill, a national
fertility industry organization, expect the governor later this month
to sign the measure, which would go into effect next year.
The measure, AB 926 by Assemblywoman
Susan Bonilla, D-Concord, would repeal a ban on payments to women who
provide eggs for scientific research. However, the measure would not
affect the ban on payments to egg providers in research funded by the
$3 billion California stem cell agency. That ban is covered by a
separate legal provision. Stem cell researchers around the country have complained that they they cannot get eggs without payment.
Women in California can be paid for
providing eggs for reproductive purposes. According to a legislative analysis, payments can run as high as $50,000 for women with special
characteristics but average around $9,000 for each session, which can
generate more than one egg.
The sponsor of the legislation is the
American Society for Reproductive Medicine of Alabama, whose members
represent a wide swath of the $5 billion-a-year fertility business.
The measure would open new business avenues for the industry.
Bonilla argues that the measure allows women to be treated on the same footing as men who provide sperm for
research and would encourage more research into reproductive health issues.
Opponents argue that the safety of the
egg production procedures has not been well-established including
their long-term impact. They also argue that allowing payment would
lead to exploitation of poor and minority women.
The bill received its final
legislative approval on July 1 when the Senate passed it on a 24-9
vote.

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Challenge to WARF hESC Patents Cites Recent U.S. Supreme Court Decision

Posted: July 7, 2013 at 2:59 am

Patents on human embryonic stem cells
are being challenged in a new legal filing that cites the recent U.S.
Supreme Court decision that barred the patenting of human genes.
The stem cell case involves the
Wisconsin Alumni Research Foundation (WARF), which holds the patents on the
much-heralded work performed by Jamie Thomson  at the University of Wisconsin. The lawsuit was filed
by the Public Patent Foundation of New York City on behalf of
Consumer Watchdog, a nonprofit group in Santa Monica, Ca. Jeanne
Loring, director of the Center for Regenerative Medicine at the
Scripps Research Institute, is also involved along with Alan
Trounson, president of the California stem cell agency. The agency
itself is not a party.
This week's filing follows the
so-called Myriad decision last month by the nation's highest court which said,

“Myriad did not create anything. To
be sure, it found an important and useful gene, but separating that
gene from its surrounding genetic material is not an act of
invention.”

"WARF did not create or alter the
properties inherent in stem cells any more than Myriad created or
altered the genetic information encoded in the DNA it claimed.” 

The legal filing came in an appeal of
an earlier decision by the U.S. Patent Office. The Public Patent
Foundation, which was a successful party in the Myriad case, did the earlier legal work on the challenge to the WARF patents as well as this
week's appeal.
The appeal, prepared by Dan Ravicher,
said the WARF patents have "put a severe burden on taxpayer-funded
research in California.”
Trounson released a statement saying,

“We don't want to do anything that
gets in the way of finding treatments for some of the biggest killers
today, so we feel that all patients with all kinds of diseases
deserve to have access to these kinds of cells.”

Loring was quoted in a Consumer Watchdog press release as saying,

"Human embryonic stem cells hold
great promise for advancing human health, and no one has the ethical
right to own them.”

John M. Simpson of Consumer Watchdog
said,

 “The best course if WARF truly
cares about scientific advancement would be to
simply abandon these over-reaching patent claims.”

A story by Bradley Fikes in the San
Diego U-T cited intellectual property attorney Lisa Haile of DLA
Piper as saying,

“A successful use of the Myriad case
as a precedent for throwing out the foundation’s patent would open
the door to similar challenges in just about any biotech product
using material derived from life.”

WARF made no immediate comment.

Other stories on the WARF challenge
appeared in the Milwaukee Journal, Genomeweb and the LaCross Tribune. 

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California Legislation, Human Egg Sales and Profits

Posted: July 7, 2013 at 2:59 am

California legislation to allow women
to be paid for their eggs for scientific research is sailing toward
final passage literally swaddled in motherhood and apple pie
arguments. Missing from the debate is a key reason behind
the bill – building profits for what some call the “baby
business.”

The legislation is touted as providing
equal treatment for women, permitting them to be paid for supplying
eggs for stem cell and other research, much as men are paid for
sperm. It also would put women who sell their eggs for research on an
equal economic footing with women who sell their eggs for fertility
treatments, which is currently permitted under state law. Payments to
those women range from an average of $9,000 to as much as $50,000,
according to a legislative analysis of the bill.

 Assemblywoman Susan Bonillla,
D-Concord, author of the bill(AB926), says,

“It is time to let women, just as any
other research subject, make an informed decision as to
participation, and justly compensate them for doing so.”

She also says that the ban on payments
has had serious impact on fertility research. In a legislative bill analysis, she says,

“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.”

Bonilla is carrying the measure on
behalf of an industry group, the American Society for Reproductive Medicine of Alabama. The fertility or baby business, which is largely
unregulated, brings in about $5 billion annually in the United
States from something like 500 clinics. It has grown rapidly over the
last couple of decades, but is likely heading for a soft spot.
Little public information is available
on the Internet discussing the industry's economic challenges.
However, demographic studies show that the size of the key market
for fertility services is stagnating. A 2012 report by the federal
government projects that the number of women in the 35 to 44 age
group, prime consumers of fertility services, is likely to grow only
0.5 percent from 2010 to 2020. And since that forecast was made, the
Census Bureau has downgraded its projections for total population
growth.
Bonilla's legislation effectively adds
a new, potential revenue stream for the industry. Fertility clinics
would be able to buy the eggs and then resell them to researchers,
adding premiums for eggs from women with special characteristics. The bill would also add a tool for bringing down the cost of fertility
treatments, which can run as much as $12,000 to $17,000 a round or
more and require several rounds, according to the NIH. Clinics could discount those prices for some women, bringing in
new customers, if they agree to authorize the use of excess eggs for
scientific research.
None of this appears necessarily
pernicious. What is pernicious is the absence of discussion of the
economics of the legislation. Without a full understanding of all
that is at stake, including economic issues and motivations,
legislators, the governor and the public are hard-pressed to make
good decisions about a significant change in California law.
Opponents of the legislation have
raised serious questions about the treatment of women by fertility
clinics, noting that the bill would turn egg providers into “vendors”
– not patients of the clinics. The Center for Genetics and Society
in Berkeley has captured the arguments in opposition including
testimony before a Senate committee hearing early in June.
Jennifer Schneider, a physician who
lost a 31-year-old daughter to cancer seven years after the younger
woman sold her eggs three times, told lawmakers,

“Unlike infertile women who are
considered patients, egg donors are treated as vendors( (her italics).
When they walk out of the IVF clinic, no one keeps track of them. 
My daughter’s death was not reported. The long-term risks of egg
donation are unknown."

Sindy Wei, a former egg provider and
now a physician with a Ph.D. in biology, testified that she wound up
in an intensive care unit after 60 eggs were extracted from her in
2001. She said,

“I fear that cases like mine are
buried deep by fertility centers concerned about their image. An
industry thriving on profits and reputation has little incentive to
report adverse events, or protect the health and medical rights of
donors.”

Where is the $3 billion California stem
cell agency on all this? The agency has not taken a position on the
bill nor have any major research organizations. The measure does not
change the law affecting agency-funded research, which bans the use of
compensation for eggs in its research. Enactment of the law, however, would
create a two-tier stem cell research standard in California, one for
scientists not constrained by the payment ban and another for those
who could use the full range of research tools. Some stem cell
researchers may well think that they have become disadvantaged as a
result.

(Editor's note: An earlier version of this article said the IVF business generated $4 billion in revenues annually. More recent estimates place it at $5 billion.)

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Stem cell therapy can be done in PH — PMA President

Posted: July 5, 2013 at 7:46 pm

Manila, Philippines -- Philippine Medical Association (PMA) President Dr. Leo Olarte said yesterday Filipinos need not go abroad or seek foreign consultation if they want to undergo stem cell therapy to cure an ailment.

Olarte warned of the risks and complications involved in stem cell therapy when improperly administered, citing the case of a government official who complained of feeling weak after the procedure was performed on him by a group of foreign medical team inside a posh hotel in Mandaluyong City.

The PMA chief said there are local experts who are capable of performing safe and reliable stem cell treatments in the country using the patient's own stem cells.

The other day, a lawyer for Dangerous Drugs Board (DDB) Chairman Antonio Villar faced the media and revealed that her client is filing charges against the foreign medical team who performed the procedure on him.

Lawyer Claire Pagayanan said the lead doctor who performed the stem cell therapy was from Germany while the other two doctors and nurses who assisted him were from Thailand.

Villar reportedly paid 15,000 euros or approximately P1.2 million for the procedure.

"Doctors who perform this therapy should be licensed by the Philippine Food and Drugs Administration. Before foreign doctors could perform here, they should apply for a license from the Professional Regulation Commission," he said. Those who fail to do so will be in "clear illegal practice of medicine in violation of the Medical Act of 1959," Olarte added.

For his part, PMA spokesperson Dr. Mike Aragon lamented how colonial mentality has affected the decision-making process of some Filipinos. "Maybe they are not well-informed about stem cell therapy, or it is the colonial mentality. Many of us think that if it is foreign, it is something good," Aragon said.

In the country, the only Department of Health (DoH)-approved stem cells that can be used for treatment are the patient's own stem cells harvested from his or her blood, bone marrow and fat.

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