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Stem-cell treatment not a cure-all, charging patients for clinical study unethical – 21 doc groups

By: Jet Villa, InterAksyon.com August 11, 2013 8:10 AM

REUTERS FILE PHOTO

InterAksyon.com The online news portal of TV5

MANILA - Twenty-one medical organizations have already signed a position statement, calling for stricter regulations of stem cell products and physicians doing the transplant.

These are the: Philippine College of Physicians, Philippine College of Geriatric Medicine, Philippine Society of Allergy, Asthma and Immunology, Philippine Society of Hematology and Blood Transfusion, Philippine Society of Nephrology, Philippine Neurological Society,

Philippine Society of General Surgeons, Philippine College of Surgeons, Philippine Heart Association, Philippine Society of Endocrinology and Metabolism, Philippine Society of Medical Oncology, Diabetes Philippines, Philippine Society of General Medicine, Philippine Society for Vascular Surgery,

Philippine College of Chest Physicians, Philippine Rheumatology Association, Philippine Society of Gastroenterology, Philippine Society for Microbiology and Infectious Diseases, Philippine Academy of Rehabilitation Medicine, Philippine Society of Nuclear Medicine, and Academy of Filipino Neurosurgeons.

The groups have called on the Department of Health and the Food and Drug Administration to issue clearer regulations for stem cell therapy for practicing clinicians to safeguard the health of Filipinos.

Stem cell therapy for unproven indications is proliferating in the Philippines and posing serious safety issues to unknowing clients, they said.

(We are) alarmed by these uncontrolled practices which may include false claims, misinformation, and exorbitant fees, the added.

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Stem-cell treatment not a cure-all, charging patients for clinical study unethical - 21 doc groups

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

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

Andrew Madoff Battling Stage-Four Cancer, Receives Donor Infusion After Stem Cell Transplant

By Nicole Weisensee Egan

08/09/2013 at 04:15 PM EDT

On Wednesday, Madoff received a donor lymphocyte infusion in hopes of salvaging the stem cell transplant he received on May 29th, after several rounds of chemotherapy and radiation to treat his mantle cell lymphoma.

"Things were humming along nicely, but then one of the components of the transplant started failing," he says. "We kind of waited it out a couple of weeks to see if it would fail entirely."

His situation did not improve, which led to the donor infusion on Tuesday.

"This will hopefully prevent it from failing," he says. "If they didn't do this, it would certainly have failed."

With doctors saying there is only a 50/50 chance that the infusion will work, Madoff insists he is trying to stay positive.

"It's hard. It's been a long road. I've been receiving treatment since January, and it's a lot," he says, ticking off, "Six rounds of chemotherapy, then radiation, then more chemo before the transplant, then the transplant itself."

Madoff, whose stage one cancer (confined to a single lymph node), was originally diagnosed in 2003, now has stage four cancer, which has spread throughout his body. He revealed his recurrence of the disease to PEOPLE earlier this year, after his condition had been diagnosed during his annual checkup last October.

He says that after the PEOPLE story ran he received hundreds of emails and letters of support from total strangers.

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Andrew Madoff Battling Stage-Four Cancer, Receives Donor Infusion After Stem Cell Transplant

Stem Cell Therapy Shows Promise in Repairing Brain Damage Even Hours After Stroke Occurs

Durham, NC (PRWEB) August 09, 2013

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. ###

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.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS (http://www.StemCells.com), in its 31th year, is the world's first journal devoted to this fast paced field of research. The Oncologist (http://www.TheOncologist.com), also a monthly peer-reviewed publication, in its 18th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

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Stem Cell Therapy Shows Promise in Repairing Brain Damage Even Hours After Stroke Occurs

Stem Cell Therapeutics Acquires an Exclusive Option to License Prostate Cancer Stem Cell Assets

TORONTO, ONTARIO--(Marketwired - Aug 9, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS)(SCTPF), a biopharmaceutical company developing cancer stem cell-related therapeutics, today announced that it has entered into an option agreement to exclusively license worldwide rights to a series of prostate cancer stem cell assets from the University of York, United Kingdom. The assets originate from research funded by Yorkshire Cancer Research (YCR) and conducted in the YCR Cancer Research Unit, University of York, under the direction of Professor Norman Maitland. Stem Cell Therapeutics (SCT) intends to work closely with the Maitland group, leveraging its internal scientific strengths and its existing global network of collaborators.

"This agreement provides Stem Cell Therapeutics with an opportunity to evaluate several highly promising therapeutic targets, all of which are expressed on prostate cancer stem cells, as well as on other types of cancers," added Dr. Bob Uger, SCT's Chief Scientific Officer. "Much of the York group's research is focused on hypothesis testing using powerful multicellular in vitro models and xenograft in vivo models of tumour development/metastasis. We will extend this research into the generation of monoclonal antibodies to these targets, with an ultimate goal of identifying new therapeutic development candidates."

Dr. Maitland's research group is focused on the development and aetiology of human prostate cancer. They have compiled gene expression profiles for various cell types present in prostate tumors and in normal prostate tissue, and have mined these data for genes and signaling pathways that affect cell fate. This has demonstrated that heterogeneity within human prostate cancers is due to two independent events: carcinogenic changes and aberrant differentiation. Exploiting knowledge of the genetic signature of prostate cancer stem cells, the Maitland group has identified novel avenues for treatment which could delay, or even prevent, tumour recurrence. The group has also shown that prostate cancer stem cells have an active resistance mechanism to many conventional therapies, such as radiotherapy and chemotherapy. These latter therapies are directed against the majority of cells in the tumour (the most differentiated cells), but do not affect the minority population, which are the cancer stem cells. Thus, prostate cancer stem cells form a root for post therapy recurrence.

"This commercial partnership should be the ultimate outcome for all charity-supported cancer research. We plan to exploit more than 10 years of research into prostate cancer stem cells in York to develop new treatments for the benefit of patients here and around the world," commented Professor Maitland. "Our unique approach, supported by Yorkshire Cancer Research, has studied fragments of real tumors donated by men with prostate cancer, and has provided new insights into how the rare stem cells work, and more importantly, how we can kill them. With the collaboration and expertise of Stem Cell Therapeutics, a company dedicated to cancer stem cell R&D, we can at last produce the actual drugs and biological agents to achieve our goal."

The execution of the definitive license agreement is subject to final due diligence and certain conditions being met by SCT over the next 6-9 months. The license agreement will contain customary terms and provisions for assets at this stage of development, including an initial license consideration, milestone payments, royalties on sales and sublicensing terms.

"We consider ourselves fortunate to have secured these assets from such a preeminent cancer stem cell research group. Dr. Maitland has long been considered a world-authority in prostate cancer research and we look forward to working closely with both him and his colleague, Dr. Anne Collins," remarked SCT's CEO, Dr. Niclas Stiernholm. "This development is a continuation of our strategy to build individual programs and collaborations around strong scientific minds with demonstrated global leadership in the cancer stem cell arena."

About Cancer Stem Cells:

The cancer stem cell (CSC) concept postulates that the growth of tumors is driven by a rare population of dedicated cells that have stem cell-like properties, including self-renewal. While the bulk of a tumor consists of rapidly proliferating cells and differentiated cells, neither of which is capable of self-renewal, a small population of CSCs provides for long-term maintenance of the cancer. Although the CSC concept was first postulated in the 1960s, it wasn't until 1994 that proof of their existence was demonstrated, when Dr. John Dick and colleagues in Toronto isolated CSCs (known as leukemic stem cells, or LSCs) from bulk acute myeloid leukemia cells. More recently, CSCs have been identified in many other human malignancies, including solid tumors such as bladder, brain, breast, colon, ovarian and prostate cancers. There is accumulating evidence that CSCs are resistant to conventional chemotherapies and radiation. Thus, CSCs are thought to be responsible for a phenomenon well known to oncologists: most patients will experience an initial response to conventional chemotherapies but will ultimately relapse. To cure cancer, CSCs need to be destroyed, but the current armament of therapies is poorly equipped to do so.

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (SCT) is a biopharmaceutical company dedicated to advancing cancer stem cell discoveries into novel and innovative cancer therapies. Building on over half a century of leading and groundbreaking Canadian stem cell research, the company is supported by established links to a group of Toronto academic research institutes and cancer treatment centers, representing one of the world's most acclaimed cancer research hubs. The Company has two premier preclinical programs, SIRPaFc and a CD200 monoclonal antibody (mAb), which target two key immunoregulatory pathways that tumor cells exploit to evade the host immune system. SIRPaFc is an antibody-like fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and several other tumors. The CD200 mAb is a fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumors. SCT's clinical stage programs include the recently in-licensed program focused on the structure of tigecycline, which is currently being evaluated in a multi-centre Phase I study in patients with acute myeloid leukemia (AML), as well as TTI-1612, a non-cancer stem cell asset that recently completed a 28-patient Phase I trial in interstitial cystitis ("IC") patients. For more information, visit: http://www.stemcellthera.com.

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Stem Cell Therapeutics Acquires an Exclusive Option to License Prostate Cancer Stem Cell Assets

Stem cell therapy shows promise in repairing brain damage

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.

###

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

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


Stem Cell Therapy Treatment for Transverse Myelitis by Dr Alok Sharma, Mumbai, India.
Improvement seen after Stem Cell Therapy Treatment for Transverse Myelitis by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy PT assessment: Objectively : 1) Grade 3-4 spasticity in...

By: Neurogen Brain and Spine Institute

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

Blackburn resident launches campaign to help find Asian stem cell donors

Blackburn resident launches campaign to help find Asian stem cell donors

8:30am Thursday 8th August 2013 in News By Chloe Glover, Reporter

Saima Ashraf with her plea for Rayaan

A MAJOR drive to encourage the Asian community to donate stem cells has been launched in East Lancashire to help save the life of a young boy.

Blackburn resident Saima Ashraf, 30, has spearheaded the campaign to find a donor for six-year-old Rayaan Siddiqui after being shocked to find out that fewer than three per cent of Asian people in the UK were on the stem cell donor register.

Rayaan, from Welling, in Kent, who was diagnosed with a rare type of blood cancer, has a fight against time to find a donor to treat the condition called hemophagocytic lymphohistiocytosis.

With a need for stem cells almost identical to his own for treatment to be effective, the best chance of finding a suitable match lies within someone of his own ethnic background.

Ms Ashraf, who works as an auditor at Thornton General, was compelled to head the search in Lancashire after hearing about his condition on a radio show.

According to recent statistics, only 50 per cent of people with the disease ever manage to find a matching donor.

She will hold a drive in conjunction with Delete Blood Cancer UK in Blackburn on August 31 to register people who will then be checked to see if they provide a match for Raayan.

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Blackburn resident launches campaign to help find Asian stem cell donors