StemCell Therapy

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

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.

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DOH sets deadline for stem cell therapy accreditation

Stem Cell Therapy Treatment for Stroke by Dr Alok Sharma, Mumbai, India.
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Stem Cell Therapy Treatment for Transverse Myelitis by Dr Alok Sharma, Mumbai, India. - Video

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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Stem cell therapy shows promise in repairing brain damage

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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Foreign doctors need permit for stem cell therapy

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

Hello Doctor Zee 24 Taas Dr Nandini Gokulchandran talks about Stem Cell Therapy Treatments
Hello Doctor Zee 24 Taas Dr Nandini Gokulchandran talks about Stem Cell Therapy Treatments. Telecast on 23/6/2013 Stem Cell Therapy done at Dr Alok Sharma Ne...

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Stem Cell Therapy for Knees

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Discussing: My intro Stem Cell Therapy
This video explains my intro into the World of MS.

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Discussing: My intro Stem Cell Therapy - Video

NEW YORK, NY and PETAH TIKVA, ISRAEL--(Marketwired - Jul 29, 2013) - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that the European Commission has granted Orphan Drug Designation for NurOwn, the Company's stem cell therapy consisting of autologous bone marrow-derived mesenchymal stromal cells secreting neurotrophic factors, for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease.NurOwn received Orphan Drug Designation from the Food and Drug Administration (FDA) in 2011.

Orphan drugs benefit from 10 years market exclusivity in the European Union (EU) after marketing approval. Additional benefits for sponsor companies include reduced fees for various centralized activities including applications for marketing authorization, inspections and protocol assistance, as well as possible eligibility for EU grants and other R&D-supporting initiatives.

BrainStorm is currently conducting a Phase IIa dose-escalating trial with 12 ALS patients at the Hadassah Medical Center in Jerusalem, Israel. The company anticipates launching a Phase II multi-center trial at three leading institutions in the United States towards the end of 2013, pending FDA approval.

About BrainStorm Cell Therapeutics, Inc.BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the company's website at http://www.brainstorm-cell.com.

Safe Harbor Statement - Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements.The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov.These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements.The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm's NurOwn Cell Therapy Receives Orphan Drug Designation in the European Union for ALS

FAQ4 A Scientific Basis for Stem Cell Therapy
http://youtu.be/uf_toA9Nzuo With all the hype online and in the media today, it is easy to believe that Stem Cell therapy is ALSO #39;hype #39;, but it actually eme...

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FAQ4 A Scientific Basis for Stem Cell Therapy - Video

TULSA, Oklahoma -

A controversial therapy that's not available for humans is being used on their pets. Stem cells are helping dogs and cats heal faster and get rid of pain as the animals get older.

Mandy Clinton loves her dog and she'd do just about anything for her.

"I've had her for 14 years. She's my homegirl," Clinton said about Libbi.

But Libbi has come up with a hitch in her giddy up. She tripped while walking up the stairs and tore her ACL.

Clinton was looking into surgery when she learned about stem cell therapy and its ability to help dogs heal faster and reduce pain.

"I had no idea. I had no idea. It blew my mind, but I've had Libbi for 14 years, and so I was ready to do it if it was possible," she said.

Dr. Joe Landers at Heritage Veterinary Hospital will be performing Libbi's surgery on Wednesday.

They'll harvest stem cells from Libbi's stomach, process and stimulate them, then implant the stem cells on her leg joint.

"If you've ever cut your skin, deeply with a knife or something, you've had stem cell repair," said Dr. Joe Landers, DVM.

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Oklahoma Veterinarian Offering Stem Cell Therapy For Aging Pets

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(PRWEB) July 22, 2013

The Institute of Regenerative and Molecular Orthopaedics (IRMO), world-renowned stem cell therapy experts, applauds the use of stem cell therapy for treatment of spinal injuries. In recent times, stem cell therapy has been increasingly sought after to support treatments of various injuries, especially in the sports world. Its use in repairing spinal injuries comes as good news to the thousands of Americans currently living with spinal cord injuries who are seeking the latest in breakthrough medical solutions.

Stem cell therapy is of the most exciting and promising treatments in modern medicine. Inroads are made every day, as the many applications of stem cell treatments become better understood by medical professionals around the world. Experts, like Dr. Joseph Purita of the Institute of Regenerative and Molecular Orthopaedics, have been utilizing stem cell treatments for many years to treat sports injuries.

Recent scientific and technological advancements have made stem cell extraction relatively inexpensive and accessible. Today, medical professionals have unprecedented access to these remarkable cells and are increasingly applying them in new ways to better aid in the bodys repair process. This includes advances in platelet rich plasma therapy (PRP), a process that takes a concentration of a persons own plasma and injects it into areas in need of new growth and tissue repair.

The use of stem cell therapy in the treatment of spinal cord injuries presents probably the biggest challenge yet for proponents of the treatment. Researchers are increasingly using stem cells to hopefully better understand its capabilities. The hope for spinal cord injuries is that one day stem cells can be used to generate new passageways for nerve signals to connect to muscles. The more stem cells are used for treatment in spinal cord injuries, the closer the medical field will be to fulfilling this promise.

Headed by the world-renowned stem cell treatment pioneer, Dr. Purita, the Institute of Regenerative and Molecular Orthopaedics is continually advancing the world of stem cell therapy treatments. They are one of the few orthopedic practices in existence that utilizes stem cell therapy, and PRP therapy, with orthopedic surgery to maximize a patients recovery outcome. As more stem cell treatments are being used to treat spinal injuries, Dr. Purita and his group look forward to seeing what great strides are made in battling the crippling condition in the near future.

About Stem Cell Orthopedic: The Institute of Regenerative and Molecular Orthopaedics (IRMO) is a world-class orthopedic practice and stem cell facility staffed with seasoned board certified orthopedic surgeons. They differ from most orthopedic practices because they offer stem cells and platelet rich plasma (PRP) therapy in conjunction with surgery or as alternative to surgical procedures. They utilize state-of-the-art technology and the latest in stem cell research to best treat their patients. IRMO uses hematopoietic stem cells (HSC), which are found circulating in blood, fat, and bone marrow, to help repair the body. They are headed by Medical Director, Dr. Joseph Purita, a world-renowned pioneer in laser orthopedic surgery and graduate of the esteemed Georgetown University Medical School. For more information, visit http://www.stemcellorthopedic.com/ or follow them on Facebook, Twitter, or YouTube.

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Stem Cell Orthopedic Applauds Use of Stem Cell Therapy for Spinal Injuries

LAST week, we discussed the potential of medical tourism in the country which will also provide opportunities for destinations like Baguio once tapped, and subject to competitive and international standards and government/ regulatory requirements.

So much has been written and reported about Stem Cell Therapy including its extraordinary promises that research holds for the treatment of a wide range of diseases and conditions.

This week, lets delve deeper.

What is Stem Cell Therapy?

Cell Therapy has been interchangeably called many names such as cellular therapy, fresh cell therapy, live cell therapy, glandular therapy, or xenograph or xenotransplant therapy.

The International Society for Stem Cell Research (ISSCR) describes stem cell therapy as a treatment that uses stem cells, or cells that come from stem cells, to replace or to repair a patients cells or tissues that are damaged. The stem cells might be put into the blood, or transplanted into the damaged tissue directly, or even recruited from the patients own tissues for self-repair.

Stem Cells have been differentiated based on where in the body or what stage in development they come from. ISCCR has enumerated them as follows (source:www.isscr.org):

1. Adult Stem Cells or Tissue-specific Stem Cells. Many adult tissues contain stem cells that can replace cells that die or restore tissue after injury. Skin, muscle, intestine and bone marrow, for example, each contain their own stem cells. In the bone marrow, billions of new blood cells are made every day from blood-forming stem cells. Adult stem cells are tissue-specific, meaning they are found in a given tissue in our bodies and generate the mature cell types within that particular tissue or organ. It is not clear whether all organs, such as the heart, contain stem cells. The term adult stem cells is often used very broadly and may include fetal and cord blood stem cells.

Another type of adult stem cell is the mesenchymal stem cell. These are found in a number of tissues, including bone marrow, and may be able to produce bone, cartilage and fat. It is also possible that these or similar cells may aid in the regeneration of tissues. Extensive animal studies are currently ongoing to determine if these cells may be used for treatment of diseases such as arthritis and non-healing bone fractures. It is also possible that these or similar cells modulate the immune system in response to injury.

2. Fetal Stem Cells. Fetal stem cells are taken from the fetus. The developing baby is referred to as a fetus from approximately 10 weeks of gestation. Most tissues in a fetus contain stem cells that drive the rapid growth and development of the organs. Like adult stem cells, fetal stem cells are generally tissue-specific, and generate the mature cell types within the particular tissue or organ in which they are found.

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De Leon: Medical Tourism and the Future of Stem Cell Therapy (Part 2)

#39;The results are profound #39;; Stem cell therapy used to treat animal ailments
#39;The results are profound #39;; Stem cell therapy used to treat animal ailments.

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FAQ1-Stem Cell Therapy
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