NewsLife: DOH calls for registration of stem cell therapy operators
NewsLife - DOH calls for registration of stem cell therapy operators (Reported By: Noel Perfecto) - [August 12, 2013] For more news, visit: #9659;http://www.ptvne...

By: PTV PH

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NewsLife: DOH calls for registration of stem cell therapy operators - Video

By Christian V. Esguerra Philippine Daily Inquirer

La Union Rep. Eufranio Eriguel. Photo from congress.gov.ph

MANILA, PhilippinesA congressman has joined the call to regulate stem cell therapy administered in the country.

La Union Rep. Eufranio Eriguel has introduced House Bill No. 212, which would put up a bioethics advisory board that would establish ethical standards governing the practice of stem cell research and therapy.

Under the proposed Stem Cell Research and Therapy Act of 2013, the board shall be responsible for addressing contentious ethical, scientific and legal issues in stem cell and cell-based or cellular research and therapies.

There is much to be learned from stem cell therapy, its benefits and application in the cure of some of the most devastating diseases and conditions. As of now, the full promise of stem cell treatment remains unknown, Eriguel said in a statement.

But the cost far outweighs its benefits because it is very expensive and only a few physicians are trained to do stem cell procedures here in the Philippines.

In his proposal, the board will be headed by the health secretary and the National Transplant Ethics Committee, while the Food and Drug Administration director will serve as vice chairman.

A proposed institutional review committee will be tasked to approve stem cell and cell-based or cellular research and therapies based on existing Department of Health guidelines.

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Bill filed to regulate stem cell therapy in PH

By: Jet Villa, InterAksyon.com August 13, 2013 8:42 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines - The Department of Health (DOH) has given all health facilities practicing stem cell therapy and companies importing and producing stem cell products untilAug. 31to apply for accreditation and product registration, respectively.

Nick Lutero, director of the DOH-Bureau of Health Facilities and Services, said it will be considered illegal for facilities to do stem cell procedures if they fail to comply with the requirement.

Papatigil namin ang pag-conduct ng therapy. For those still continuing to practice, I think we have sufficient laws, particularly on the illegal practice of medicine. They could be criminally liable, he said in a chance interview.

Lutero lamented that only five hospitals have applied for registration although the DOH had issued the guidelines on this since March.

We have done preliminary visits sa mga hospitals na ito at mukang based sa initial inspection, merong sufficient compliance sa mga facilities, he said.

Companies importing and producing stem cell products, on the other hand, should apply for registration with the Food and Drug Administration, an agency attached to the DOH.

Products that will not be applied for registration will also be considered illegal after the deadline.

Experimental treatment not for free

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DOH gives health facilities engaged in stem cell therapy until Aug. 31 to register

Manila, Philippines -- Hospitals and health facilities offering stem cell therapy have until August 31 to apply for accreditation from the Department of Health (DoH).

DoH Secretary Enrique T. Ona said a number of hospitals in Metro Manila have already applied for accreditation to perform this "innovative" treatment that has not yet been accepted as standard mode of care in the country since it needs further tests and several more layers of research.

In the first mid-year convention of the Philippine Society for Stem Cell Medicine at the Manila Hotel yesterday, Ona reiterated that stem cell therapy is "the future of medicine."

"Stem cell therapy is not a cure-all medical treatment. Patients have yet to be presented first with standard of treatment, and in many cases, stem cell treatments have to be done in conjunction with other standard modalities of treatment," he said.

The Bureau of Health Facilities and Services (BHFS) of the DoH is accepting the applications for accreditation while a bio-ethics committee and a hospital-based review board will go over the applications and decide on their approval.

Five big hospitals in Metro Manila have already applied for accreditation, said Nick Lutero, chief of the BHFS.

Lutero said initial checks have revealed that these hospitals possess the required equipment needed for the treatment but they would still have to check on requirements set by the Food and Drug Administration (FDA) in relation to the practice.

Lutero said institutions that are offering stem cell treatments can still perform the procedures pending the approval of applications. However, once formal accreditations are already given, unaccredited institutions should cease offering stem cell therapy.

More here:
DOH sets deadline for stem cell therapy accreditation

Two organizations of Filipino medical practitioners - the Philippine Medical Association (PMA) and the Philippine Society for Stem Cell Medicine (PSSCM) - are partnering to come up with ideas to help professionalize and organize the practice of stem cell therapy in the Philippines during their 1st Midyear Convention at the Historic Landmark Manila Hotel on August 12-13, 2013.

With the theme ''Current Status of the Practice of Stem Cell Therapy in the Philippines,'' the convention is expected to take up various issues surrounding stem cell therapy, which, despite the controversies, is increasingly becoming popular for treatment of certain illnesses. Among the scheduled topics for discussion in the convention are Food and Drug Administration Circular on Stem Cell Products, DOH Stem Cell Guidelines, Current Trends on Stem Cell Therapy, Clinical Use of Autologous, Adipose Derived Stem Cells, Photo-Activated Platelet-Rich Plasma for Orthopedic and Rehabilitation Applications, Umbilical Cord Blood and Cord Tissue for Stem Cell Therapy, Stem Cell Therapy in the Philippines other than for Cancer Rejuvenation, and Quality Control in Cell Transplantation.

Administrative Order 2013-0012 issued by the Department of Health (DOH) rules on the practice of stem cell, cell-based therapy, and accreditation of health facilities engaging in the treatment in the Philippines. The Professional Regulation Commission Board of Medicine (PRCBOM) requires foreign doctors wishing to practice stem cell therapy in the country to get a special temporary permit, citing their education, training, and clinical experience.

The PMA, the country's premier medical organization, has 70,000 members in 118 component medical societies, eight specialty divisions, 73 specialty and subspecialty societies, and 39 affiliate societies all over the archipelago, who advocate professional advancement and promote public health. The newly founded PSSCM is composed of physicians doing stem cell therapy and transplant. It is working closely with DOH, PRCBOM, and PMA to regulate the practice of Stem Cell therapy and protect patients.

We congratulate the Philippine Medical Association, headed by its President Dr. Leo O. Olarte, and the Philippine Society for Stem Cell Medicine, led by Dr. Rey Melchor F. Santos, in their coordinative efforts to educate and inform the public on the status of stem cell treatment as a novel medical approach in the Republic of the Philippines. CONGRATULATIONS AND MABUHAY!

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Editorial: Philippine Society for Stem Cell Medicine and Philippine Medical Association 1st Midyear Convention to be ...

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(Photo and caption from the stem cell agency blog item this morning.)

“The family was understandably upset
by the lack of consultation and in response the research team removed
the genome data from public access.”

“CIRM has benefited from these
efforts. We are currently supporting an initiative to collect tissue
samples from thousands of people with a range of incurable diseases
and create reprogrammed iPS cells from those tissues (here's
more about that initiative). These cells will be a resource for
scientists worldwide working to understand and treat diseases. Part
of this initiative includes a consent process to make sure people who
donate fully understand how their cells will be used. (This process
is formally called informed consent.) 

“The informed
consent process includes a form that identifies the purposes of the
research and describes the way cells will be used. We are also
developing education materials that will help potential donors
quickly and easily understand the basic aspects of research that will
be conducted with those cells. The end result of this collaboration
with our grantees will be a process that is truly informative to
donors.

“The informed consent process can’t entirely
eliminate all future questions on the part of the donor, but it does
ensure that donors have a chance to understand how their cells will
be used and what information will be made public—something
Henrietta Lacks and her family never had.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8PQGYcYpszg/california-stem-cell-agency-on-lacks.html

“It is important to note, however,
that we are responding to an extraordinary situation here, not
setting a precedent for research with previously stored,
de-identified specimens. The approach we have developed through
working with the Lacks family is unique because HeLa cells were taken
and used without consent, and gave rise to the most widely used human
cell line in the world, and because the family members are known by
name to millions of people.”

“Imagine if someone secretly sent
samples of your DNA to one of many companies that promise to tell you
what your genes say about you. That report would list the good news
(you’ll probably live to be 100) and the not-so-good news (you’ll
most likely develop Alzheimer’s, bipolar disorder and maybe
alcoholism). Now imagine they posted your genetic information online,
with your name on it. Some people may not mind. But I assure you,
many do: genetic information can be stigmatizing, and while it’s
illegal for employers or health insurance providers to discriminate
based on that information, this is not true for life insurance,
disability coverage or long-term care.

“'That is private family
information,” said Jeri Lacks-Whye, Lacks’s granddaughter. “It
shouldn’t have been published without our consent.'”

“This has wrapped in it science,
scientific history, ethical concerns, the bringing together of people
of very different cultures, a family with all the complications that
families have.”

“Under the pact, two descendants of
Ms. Lacks will serve on a six-member panel with scientists to review
proposals from researchers seeking to sequence the DNA of cell lines
derived from her tumor or to use DNA profiles of such cells in their
research. That gives family members a highly unusual voice in who
gets access to personal health information.

Terms call for controlled access to the
genomic data and credit to the Lacks family in papers and scientific
presentations based on the research done with the DNA data.”

“The only reason I was involved in
this is because scientists did this without the family’s consent
and then it got all of this press coverage, and no one asked the
question, 'Did the family give consent?' So I sort of waded back
in.”

“That OpEd that I
wrote was the first time I’d ever publicly expressed an opinion,
which was, 'Really?!? Are we going to continue to not ask the Lacks
family questions?' I was kind of shocked in a sense that nobody
thought to raise that issue.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7XRzMDgIWjo/skloots-collins-and-more-on-henrietta.html

“They later discovered that the cells
could thrive in a lab, a feat no human cells had achieved before.

"Soon the cells — nicknamed HeLa cells
— were being shipped from Baltimore around the world. In the 62
years since — twice as long as Ms. Lacks’s own brief life — her
cells have been the subject of more than 74,000 studies, many of
which have yielded profound insights into cell biology, vaccines, in
vitro fertilization and cancer.”

“For 62 years, (Lacks') family has
been left out of the decision-making about that research. Now, over
the past four months, the National
Institutes of Health has come to an agreement with the Lacks
family to grant them control over how Henrietta Lacks’s genome is
used.”

“(T)the Lacks family was robbed.
Scores of companies profited to the tune of tens of millions of
dollars from products they made derived from Henrietta Lacks'
cancerous cells. Maybe this will provide some impetus to a wider
consideration of the rights patients are entitled to when their
tissues are cloned and disseminated to other researchers and
ultimately put to use in profit-making ventures.”

“At the very least, this family needs
to be financially compensated for the anguish of their discovery and
for the time and energy they've put into pursuing their rights. In my
opinion, they also deserve a portion of any commercial gain that's
been made using the HeLa cells. It is only through having to give
away money that the powerful learn manners.”

“It is absolutely true that
scientists have had a blind spot when it came to the human element of
the HeLa cells.”

“Allowing a market in eggs for
research would reach beyond the current pool to target women who may
be motivated by dire need. How many low-income women might consider
selling their eggs, multiple times, to feed their children or pay the
rent?”

“Prospective egg donors must
assimilate a great deal of information in the informed consent
process, yet it remains difficult to determine the extent of their
actual understanding of egg donation and its potential risks.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/oncdCzO4V18/the-henrietta-lacks-story-and-eggs.html

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1ThJSyU8BBU/californians-top-list-of-stem-cell.html

 "Duane was captivated by the possibilities that innovation provides in improving the world in which we live." 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Bui3CXvil70/memorial-services-friday-for-duane-roth.html

Duane Roth, Connect photo

“On behalf of all the CIRM family, we
mourn the loss of our colleague and dear friend Duane Roth. 
Throughout his tenure with us, he was one of the true stewards of the
mission, offering countless insights on the role of industry in the
world of regenerative medicine and how best and efficiently to drive
therapies through to patients.  He was unfailingly a voice of
reason and optimism and always sought to find ways to make things
happen, refusing to take 'no' for an answer.  Though one of 29
Board members, his extensive participation as co-Vice Chair of the
Board, co-chair of Intellectual Property and Industry Engagement
Subcommittee and a member of our Executive Committee gave Duane a
singularly important and resonant voice in our organization. 
His passing will be deeply felt by all of us as well as by the many
patients and other CIRM stakeholders whom he touched over the years. 
We send our deepest sympathies to Renee, Duane's brothers and the
rest of the Roth family.”

“Contributions in Roth’s name can
be made to Pedal
the Cause, a fund-raiser for cancer research that Roth supported.
More than $10,000 has been raised since Roth's accident."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/58gRzPR09kU/cirms-roth-dies-following-bike-accident.html

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