StemCell Therapy

By: InterAksyon.com August 9, 2013 10:02 AM

InterAksyon.com The online news portal of TV5

MANILA, Philippines - The controversy over unregulated stem cell procedures in the country, including the role of unlicensed foreign doctors, has reached Congress, from where several alleged victims of malpractice came. The vice chairman of the House blue-ribbon panel is set to deliver a privileged speech Monday ahead of hearings on the current state of things in the stem cell therapy practice in the country, where experts warned earlier the "fad-like" atmosphere poses serious threat to public health and safety.

Rep. Doy Leachon of Oriental Mindoro is expected to train his sights on, among others: the unethical practice of stem cell therapy without Food and Drug Administration (FDA) approval and on unapproved indications; the charging of exorbitant fees for still-experimental procedures; the criminal liabilities of doctors who prey on the miseries of desperate sick patients; a review of the potential conflict of interest, unethical conduct of self-promotion and violation of FDA rules in pushing stem cell therapy and charging of fees involving the Philippine Medical Association (PMA) and Philippine Society for Stem Cell Medicine (PSSCM).

Leachon wants the academe, ethics experts and the Philippine College of Physicians to shed light on the multidimensional controversy.

The House inquiry may also focus on the deaths of two congressmen who allegedly died after undergoing stem cell therapy; and the case of Dangerous Drugs Board chairman Antonio Villar, who developed adverse reactions.

Expected to be summoned to the House hearings, besides representatives of the PMA and PSSCM are officials of the FDA, Department of Health, PRC, Securities and Exchange Commission, Bureau of Immigration, Bureau of Internal Revenue and other stakeholders.

Earlier this week, the Professional Regulations Commission (PRC) served notice it would require special permits from foreign doctors who conduct stem cell procedures in the country. It warned that those failing to do so, as well as their local partners, face criminals charges for medical malpractice.

For his part, Leachon--saying a class suit is possible against doctors in cases where the stem cell therapy was found to have caused deaths and adverse reactions--encouraged patients victimized by "unscrupulous con artists and who developed side effects" to report to his office.

Leachon, a lawyer, was a TOYM awardee in public service in 2011.

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House panel trains sights on unregulated stem-cell therapy in PH

Stem cell therapy shows promise in repairing brain damage even hours after stroke occurs

Durham, NC Stroke is a major health concern and is a leading cause of death in the United States, according to the Center for Disease Control. Despite significant research efforts, developing treatments that ensure complete recovery for stroke patients poses an extreme challenge, especially when more than a few hours have passed between onset of the stroke and administration of treatment.

However, a new study released today in STEM CELLS Translational Medicine indicates that endothelial precursor cells, which are found in the bone marrow, umbilical cord blood, and as very rare cells in peripheral blood, could make a significant difference for these patients recovery even in the later stages of stroke. In animal studies, the treatment minimized the initial brain injury and helped repair the stroke damage.

Previous studies indicated that stem/progenitor cells derived from human umbilical cord blood (hUCB) improved functional recovery in stroke models, noted Branislava Janic, Ph.D., a member of Henry Ford Health Systems Cellular and Molecular Imaging Laboratory in Detroit and lead author of the study. We wanted to examine the effect of hUCB-derived AC133+ endothelial progenitor cells (EPCs) on stroke development and resolution in rats.

Dr. Janic and his team injected rats that had suffered strokes with the stem cells. When they later examined the animals using MRI, they found that the transplanted cells had selectively migrated to the injured area and that the stem cells stopped the tissue damage from spreading, instigated regeneration, and also affected the time course for stroke resolution. A significant decrease in lesion size also was observed, at a dose of 10 million cells, as early as seven days after the strokes onset.

This led us to conclude that cord blood-derived EPCs can significantly contribute to developing more effective treatments that allow broader time period for intervention, minimize the initial brain injury and help repair the damage in later post-stroke phases, Dr. Janic said.

The early signs of stroke are often unrecognized, and many patients cannot take advantage of clot-busting treatments within the required few hours after stroke onset, said Anthony Atala, M.D., editor of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. In this animal study, a combination of stem cells shows promise for healing stroke damage when administered 24 hours after the stroke.

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The full article, Intravenous administration of human umbilical cord blood derived AC133+ endothelial progenitor cells in rat stroke model reduces infarct volume magnetic resonance imaging (MRI) and histological findings, can be accessed at http://www.stemcellstm.com.

About STEM CELLS Translational Medicine: STEM CELLS TRANSLATIONAL MEDICINE (SCTM), published by AlphaMed Press, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices.

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MANILA - Foreign doctors are now required to secure a permit to perform stem cell therapy in the country or face criminal liability.

The Professional Regulation Commission (PRC)s Board of Medicine (BOM) made the announcement yesterday, explaining that the requirement is part of government efforts to regulate the practice of stem cell therapy in the country to ensure the safety of patients.

In a statement, the BOM said foreign physicians who intend to practice stem cell therapy here must obtain special temporary permit from the PRC to avoid being charged with medical malpractice.

Even local doctors who have aided foreign physicians illegal practice of stem cell therapy shall be also held criminally liable, the BOM added.

To secure the special temporary permit, a foreign doctor must submit proof of education and actual practice in the field of stem cell therapy and current license authenticated by the Philippine embassy and the embassy in the country of origin.

The board said physicians should have acquired the necessary education, supervised training and extensive clinical experience prior to performing the treatment. It noted that the argument that stem cell therapy falls under the general practice of medicine since it only involves injection of stem cell solution is erroneous.

As professionals, physicians should be able to conduct self-assessment and self-evaluation regarding what they can and what they should not do, they added.

The BOM also noted that stem cell therapy should be practiced only in hospitals and clinics licensed by the Department of Heath for assurance that these medical facilities have the necessary manpower and equipment to prevent risks and hazards to patients.

The board also warned patients desiring to undergo stem cell therapy abroad to first verify the status of clinics and hospitals as well as practitioners from regulatory authorities.

Earlier, the Food and Drug Administration and the Philippine Medical Association (PMA) reported receiving numerous complaints of foreign doctors performing stem cell therapy in hotels and other non-medical facilities. The PMA said foreign doctors injected patients with animal-based stem cells at P1 million per shot, but these foreigners are not even licensed to practice medicine in the country.

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By: Jet Villa, InterAksyon.com August 6, 2013 4:34 PM

InterAksyon.com The online news portal of TV5

MANILA, Philippines - Amid a flurry of reports about unregulated procedures that have led to serious injury or even deaths, the Professional Regulation Commission (PRC) is now requiring foreign doctors wishing to practice stem cell therapy in the Philippines to obtain a special temporary permit (STP).

In a position statement, the Professional Regulatory Board of Medicine (PRBOM) said foreign doctors must submit proof of education, training and clinical experience and actual practice in the field of stem cell therapy, plus a current license to practice authenticated by the Philippine Embassy/Consulate in the country of origin when they apply for the special permits.

The board warned: Any foreign physician who practices the professionwithout a STP will be criminally liable for illegal practice of medicine.And, it added, those who have aided and abetted the foreign physicianspractice of the profession are also criminally liable.

The position paper was signed by PRBOM chairman Dr. Edgardo Fernando and members doctors Miguel Noche Jr., Florentino Doble, Restituto de Ocampo, Jose Cueto Jr., and Mildred Pareja.

Controversy hounds new group

The position statement on stem cell therapy was issued amid a growing rift among doctors over recent controversial cases, including several lawmakers who had procedures done, but whose conditions worsened.

One newly-founded group of doctors doing stem-cell transplant, the Philippine Society of Stem Cell Medicine (PSSCM), has been pitted by the controversy against the Philippine College of Physicians, Philippine Society of General Internal Medicine (PSGIM), Philippine Society of Hematology and Blood Transfusion (PSHBT) andPhilippine College of Chest Physicians (PCCP). The latter groups all believe thatPSSCM's practices are unethical as it charges huge fees from patients for stem cell procedures that are still under clinical trial.

The PRBOM has backed the Department of Health in issuing Administrative Order 2013-0012 providing the guidelines for stem cell, cell-based therapy in the country. "The practice of stem cell therapy does not constitute standard care at the present time. The claim that it offers cure to numerous diseases and conditions has not been proven through scientific research and documentation, the PRBOM said. Right now, it said, "there is difficulty verifying claims of practitioners and institutions regarding the effectivity ofavailable treatment modalities.

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PRC: Foreign docs doing stem cell therapy in PH must get special temporary permits

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