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FDA urges hotels to guard vs stem cell therapy

By: Jet Villa, InterAksyon.com June 29, 2013 6:55 PM

A scientist working on stem cells in a laboratory. AGENCE FRANCE-PRESSE

InterAksyon.com The online news portal of TV5

MANILA, Philippines -- The Food and Drug Administration has asked hotels to guard against allowing stem cell therapy to be performed in their premises.

FDA acting director Dr. Kenneth Hartigan-Go said hotels may be held liable for guests found performing or undergoing stem cell therapy in their rooms.

Go pointed out that performing medical procedures like stem cell therapy in a non-health facility is illegal.

Under Republic Act 9711 or the Food and Drug Administration Act of 2009, violators face a fine of up to P500,000 plus closure of the establishment and jail terms.

In FDA Advisory 2013-012 issued May 15, the agency warned the pubic against "receiving unapproved stem cell preparations in non-health facilities."

"Patients who might receive stem cell preparations and therapy without prior FDA-Department of Health approval run the risks of contracting infectious diseases and severe complications which may lead to permanent disabilities, physical deformities, serious iatrogenic harm, autoimmune diseases and worst death, and without the benefit of health insurance coverage," the advisory said.

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FDA urges hotels to guard vs stem cell therapy

Palace warns public on stem cell therapy

MALACAANG warned Friday the public from seeking stem cell therapy following the complaint by a government official of feeling weaker after undergoing this kind of treatment.

In a press briefing, deputy presidential spokesperson Abigail Valte said that the Department of Health (DOH) will issue an administrative order regarding the stem cell treatments in the country.

"The DOH received several reports regarding the stand-alone clinics which are offering (stem cell therapies) for skin rejuvenation to make you look younger. That's why the DOH has already acted on it. It just happened that there was an incident that was highlighted," she said.

Dangerous Drugs Board chairman Antonio Villar has admitted of undergoing recently stem cell therapy in an upscale hotel in Makati City in the hope to cure bone pains. He claimed of spending around P900,000 for the treatment. But he said he only felt weaker after the therapy.

Valte said that the public should be aware that stem cell therapies are only being undertaken in the DOH-accredited hospitals and not in any hotel or stand-alone clinics.

She also said that those being accredited are the hospitals and not the doctors.

"Come August 31, hospitals should file their accreditation requirements for them to continue to offer this treatment, if they offer that (treatment). So there's an accreditation process," she explained.

Valte said that she was also told that stem cell treatment is geared toward a certain purpose and not "cure all" ailments.

There are also certain sources that are only allowed by the DOH, in particular, the Food and Drug Administration, she said.

The official also urged the public to inform the authorities of any establishments or medical practitioners who have been violating the law.

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Palace warns public on stem cell therapy

The prime of Charito Planas, 83, after stem cell therapy on the cheap

By Rima Jessamine Granali Philippine Daily Inquirer

Now she can literally walk a mile.

Lawyer Charito Planas, 83, used to have a hard time getting up. But she can now walk without pain, thanks to stem cell therapy that cost her only five figures.

While hospitals here and abroad charge millions for the treatment, a wellness center in Tagaytay offers the service 10 times cheaper, Planas said.

The cane I used to walk with is just an accessory now, for I walk freely, without pain, without limping, said Planas, a political and human rights activist who sought refuge in the United States during the Marcos martial law administration.

My heavily grey hair has now regained its ebony shade; my skinboth body and facial skinhas regained a youthful, shining glow; and my wrinkles are slowly fading away, she added.

Planas underwent six sessions of stem cell therapy from March to April at Green and Young Health and Wellness Center, owned by Dr. Antonia Carandang Park.

VIP patients

Former President Gloria Macapagal-Arroyo reportedly visited the Filipino physician a day after she was released from detention at Veterans Memorial Medical Center (VMMC) in Quezon City after posting a P1-million bail in July last year. She was taken back to VMMC in October.

Other well-known personalities, such as justices, physicians and a senator, also reportedly frequented the wellness center.

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The prime of Charito Planas, 83, after stem cell therapy on the cheap

Palace cautions public on stem cell treatment

by Natashya Gutierrez Posted on 06/28/2013 7:43 PM |Updated 06/28/2013 8:13 PM

SKIN REJUVENATION. One of the alleged benefits of stem cell treatment is skin rejuvenation, which helps make people look younger. Graphic by Teddy Pavon/Rappler

MANILA, Philippines - Malacaang on Friday, June 28, warned Filipinos about seeking stem cell therapy from unaccredited practitioners, a treatment 3 lawmakers received before they died and which is now being investigated as possible cause of their deaths.

Deputy Presidential Spokesperson Abigail Valte said the public should take precaution, since it's not the cure-all for illnesses. "The so-called cure all is fake. There is no treatment that will cure all of your ills, Valte told reporters in response to questions about stem cell treatments.

She reiterated the Department of Health's (DOH) reminder to choose DOH-accredited hospitals for the treatment, warning clinics and hospitals that offer it without accreditation. Let me repeat, its the hospital that must be accredited, not the doctor. Not the individual. Those stand-alone clinics, they cannot get accreditation from the DOH. So that is our warning to our fellowmen, Valte said.

According to Valte, hospitals must file for accreditation with the DOH by August 31 to continue offering the treatment.

Earlier this week, the Philippine Medical Association (PMA) released a press statement saying it suspects that 3 solons of the 15th Congress may have died because of stem cell treatments from unauthorized doctors in Germany. The PMA said it would investigate the deaths.

The congressmen were not named by PMA, but among those who died recently were Bohol Rep Erico Aumentado, Camiguin Rep Pedro Romualdo and Negros Occidental Rep Ignacio Arroyo.

Don't seek treatment

At least one government official, Dangerous Drugs Board chairman Antonio Villar, has admitted he had stem cell therapy.

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Palace cautions public on stem cell treatment

Philippines government to crack down on unaccredited stem cell treatment

Manila: The government is poised to launch a crackdown on establishments offering stem cell treatment without proper accreditation amid reports that at least two lawmakers had died after undergoing such medical procedure.

Health Secretary Enrique Ona said a number of commercial establishments had mushroomed across the country offering stem cell therapy, however, only a few of these are properly accredited by the Department of Health.

Reports quoted Ona as saying that patrons are putting their lives at risk by getting service from these practitioners instead of government accredited establishments.

The crackdown on unlicensed clinics and hospitals providing these kind of medical services in the country came in the wake of reports that two lawmakers and a government executive had died after undergoing stem cell therapy.

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According to Dr Leo Olarte, President of the Philippine Medical Association, the three had separately undergone stem cell therapy to cure their respective illnesses, particularly liver cancer, heart disease and pneumonia. The three were all senior aged.

We were told that the two died one year after undergoing the medical procedures while the third passed away only recently, he said.

At least one of the patients, received treatment from a doctor who had studied in Germany who is known to use stem cells taken from non-human sources such as rabbits and sheep.

Stem cell therapies is a relatively new field in medicine, and according to Olarte, they should only be performed in government-accredited hospitals and clinics and the cells should only be taken from the patient to minimise the risk of rejection.

Rejection, the process wherein the patients own antibodies react of a foreign cell, can be fatal to the patient.

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Philippines government to crack down on unaccredited stem cell treatment

Pluripotent stem cell-derived neurons may be a viable Parkinson’s disease treatment

Public release date: 28-Jun-2013 [ | E-mail | Share ]

Contact: Robert Miranda cogcomm@aol.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Putnam Valley, NY. (Jun. 28 2013) A team of researchers from Rush University, Yale University, the University of Colorado and the St. Kitts Biomedical Research Foundation transplanted human embryonic stem cells into primate laboratory animals modeled with Parkinson's disease and found "robust survival" of the cells after six weeks and indications that the cells were "well integrated" into the host animals. The study appears as an early e-publication for the journal Cell Transplantation, and is now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/pre-prints/ct1000wakeman.

"Parkinson's disease was one of the first neurological disorders to be studied for potential replacement of lost neurons," said Dr. D. Eugene Redmond of Yale University School of Medicine. "Since the 1970s there has been significant progress with learning the required gene expression, growth factors and culture conditions for differentiating cells into apparent dopamine neurons."

However, the researchers noted that transplanted dopamine neurons have not produced "long-lasting midbrain specific neurons when transplanted into rodents or monkeys" and there have only been pilot reports of functional improvement.

According to the study authors, their study tested the long-term survival and functional benefit of apparent dopamine neurons in monkeys modeled with Parkinson's disease. As with other studies, their results found that the gene expression of the rate limiting synthetic enzyme for dopamine production, tyrosine hydroxylase (TH), was "transient" after transplantation, raising questions about the optimal cell stage and culture environment that favor graft survival and the factors that could impact cell transplantation. Once more, a more robust immunosuppression regimen than employed in other primate studies resulted in better cell survival.

"Our results demonstrate that pluripotent stem cell line-derived neurons retain the capacity to robustly survive and respond to cues in the primate brain," they wrote. "The absence of TH expression indicates that other methods may be necessary to produce and maintain the proper midbrain dopaminergic form of the cells in vivo."

While their study demonstrated robust survival of the cells, the researchers said that longer term studies are required to better understand what factors may impact long-term function replacement and whether they demonstrate significant reversal of parkinsonism, tumor formation or dyskinesias, the latter being a side effect of current treatments for Parkinson's Disease.

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Pluripotent stem cell-derived neurons may be a viable Parkinson's disease treatment

Palace: ‘Cure-all’ stem cell therapies not true

MANILA - Hospitals in the Philippines offering stem cell treatment should be accredited by the Department of Health, Malacaang said Friday. Deputy presidential spokesperson Abigail Valte said hospitals must file the needed requirements for accreditation beginning August 31.

The DOH will issue an administrative order regarding this in the wake of reports that three politicians died after undergoing the treatment abroad. Ang ina-accredit po ng DOH ay mga ospital para po doon sa mga ganitong treatment and come August 31, kailangan na pong mag-file ng mga ospital noong kanilang accreditation requirements for them to continue to offer this treatment, kung sakaling meron na po sila. So may accreditation process po yan, Valte said. She warned the public against individuals or clinics that claim they are authorized to conduct stem cell operations and those that claim they are capable of giving cure-all stem cell treatments. Uulitin po natin, yung ospital po yung ina-accredit hindi po yung doktor. Hindi po individual. Yung mga stand-alone clinic po, hindi po yan pwedeng magpa-accredit sa DOH so yun po yung isang warning po natin doon sa ating mga kababayan, Valte said. Isa pa pong interesting point, mula po sa DOH: Yung stem cell treatment daw po is geared toward a certain purpose. Yung mga sinasabi pong mga cure-all ay peke po yun. Wala pong ganoong treatment that will cure all of your ills much less your love problems. Pero meron pong mga kinds po ng mga stem cell treatment. Meron ho tayong nung prohibited, iyong galing po sa embryo at saka mga plant products. Meron po tayo nung restricted, galing po yan sa humans pero nagkakaroon ng genetic manipulation at kailangan po, yung mga produktong meron po nyan, kailangan ho iyan ng clearance mula po sa FDA. At yung mga allowed naman po, yung stem cells na galing sa humans, from the individual himself who is to be treated, the patient, or from donors.

She said the public may report to the DOH any violation. Pag meron ho kayong mga nakitang tingin ninyo ay lumalabag, i-report po natin sa DOH kasi pwede po silang ipasara, or pwede pong masuspende iyong lisensiya ng any medical practitioner na nage-engage doon sa mga pinapagbawal po ng Department of Health pagdating po dito sa stem cell treatment. So huwag po tayong magpapaloko. Ang ospital po ang pwedeng may accreditation para mag-facilitate po ng mga stem cell treatments, she said.

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Palace: 'Cure-all' stem cell therapies not true

Probe on stem cell treatments sought

MANILA -- A Visayan lawmaker sought a congressional inquiry Saturday parallel to the investigation conducted by medical groups on the stem cell treatments done in the country.

Malacaang earlier warned the public against stem cell therapy following the recent incident involving a lawmaker who undergone the treatment but has experienced other health problems.

Western Samar Representative Mel Senen Sarmiento sought for the inquiry following the deaths of two lawmakers which are linked to complications brought by the treatment.

The late Bohol Representative Erico Aumentado and Pedro Romualdo of Camiguin supposedly died after undergoing the stem cell treatment overseas

"I will definitely ask for a congressional inquiry, parallel to any other investigations by government agencies and independent medical groups. This concerns public safety. I am also concerned about reports of stem cell treatments being done in the country," Sarmiento said.

It was reported that the Philippine Medical Association (PMA) and the Philippine Society for Stem Cell Medicine (PSSCM) is conducting an investigation as to the circumstances of the death of three politicians who went to Germany for the treatment.

Dr. Leo Olarte, PMA's president and PSSCM's spokesperson refused to name the politicians pending the result of the investigation.

The PMA and the PSSCM had also warned Filipinos about the safety of the treatment being done by German doctors in five-star hotels for P1 million using xenogenic or animal-based stem cell therapy.

"This is definitely a very anomalous situation which the DOH (Department of Health) should seriously look into considering the health hazards it could inflict on public safety and health. Congress, in consultation with all concerned government agencies and private entities, should act promptly," Sarmiento said.

Sarmiento said the government should come out with a national policy on the medical issue.

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Probe on stem cell treatments sought