Docs seek stop to expensive, experimental stem cell therapy

By Philip C. Tubeza Philippine Daily Inquirer

MANILA, PhilippinesSaying that doctors were exacting exorbitant fees for what is still experimental medicine, the Philippine College of Physicians (PCP) launched Tuesday an online petition urging the Department of Health (DOH) to put a stop to experimental stem cell therapies in the country.

Human stem cell therapy for unproven indications is proliferating in the Philippines and posing serious safety issues to unknowing Filipinos The Philippine College of Physicians is alarmed by the false claims, misinformation and exorbitant fees for such stem cell treatments, read the petition on http://www.change.org.

The PCP urged the DOH to issue a cease and desist order to all doctors performing such therapies as the Philippine Health Insurance Corp. (PhilHealth) clarified that stem cell therapy was not covered by the governments universal healthcare program.

Cease and desist

We, the undersigned, call on the (DOH) to issue a cease and desist order to all doctors, clinics and hospitals that [offer] human stem cell therapy for unproven indications until scientific evidence to support claims of efficacy and safety are approved by the Food and Drug Administration, it said.

The PCP, the umbrella organization of Internal Medicine specialists in the country, said that transplanting human blood-forming stem cells to treat cancerous and noncancerous diseases of the blood was the most widely accepted clinical application of stem cell therapy.

The effectiveness and safety of human stem cell therapy has yet to be proven for heart, neurologic, skin, rheumatologic and gastrointestinal diseases, diabetes, hypertension, autism, cancer, aging and aesthetics, HIV/AIDS and other conditions, the group said.

Lack of evidence

Despite the lack of solid scientific evidence to support the [application] of human stem cell therapy for these conditions, reports of its use precisely for these conditions being received and exorbitant fees being paid by prominent personalities abound in media, the PCP said.

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Docs seek stop to expensive, experimental stem cell therapy

Therapy Cells, Inc Receives USA Patent Granted for Revolutionary Cell Therapy

CHEYENNE, WY- (ACCESSWIRE - August 20,2013) - Therapy Cells Inc (OTC Pink: TCEL) announces that on 13 February 2013, US patent US 11/702,895 was awarded to renowned scientist Dr Patrick Casey and Transplantation Ltd, for his transformational cell therapy, exclusively licensed to Therapy Cells Inc for use in human applications.

This revolutionary science dispenses with the traditional notion that cells cannot divide once they are fully mature. Dr Casey has shown that adult cells, given the right environment, can in fact divide and be grown in the laboratory. These new cells can then be used for transportation back to damaged tissue in the body, to enact tissue and organ healing.

The research team headed by Dr Casey has to date treated more than 80 horses including thoroughbreds, standardbreds, polo ponies and horses at the highest level of equestrian competition.

"With a growing level of trial success in horses, Therapy Cells' target is to gain FDA approval, and in short order have human applications in human tendons," Dr Casey says. "An initial valuation of $30 million USD for our science and technology has been appraised. FDA approval for clinical use of this technology in humans, will likely increase this factor by at least 10 times." The horse is an FDA approved model species for athletic injuries.

Dr Casey is a Veterinary graduate from Massey University (BVSc, 1988), and graduate from the University of California in 1992 with a Doctor of Philosophy (PhD, Comparative Pathology). During his time in the United States he also completed an Equine Surgical Internship at Hagyard-Davidson and McGee, Lexington, Kentucky, followed by a three year residency programme in Equine Reproduction, with a minor in Equine Medicine at UC Davis. In 1992, 1993, and 1994 he received a post-doctoral fellowship from the Equine Research Laboratory at the University of California, which allowed him to set up with the late, world renowned, Professor Liggins at the University of Auckland, New Zealand.

Since 2011, Dr Casey has been chief scientific consultant to a public company in the USA - Therapy Cells Inc (TCEL on the OTC Market).

This exciting Bio Tech/Med tech Company holds the exclusive technology that allows adult cells from a specific tissue (e.g. Achilles tendon) to grow again from an individual to enact repair and regeneration of that tissue, effectively by-passing the need for Stem Cell treatment.

"The financial and curative potential of this biotechnology platform is immediately obvious," states Dr Casey. "When we talk about regenerative procedures, the ability to rejuvenate tissues and organs with cultivated natural cell therapy, it's easy to understand how enormous the opportunity and the impact will be. The awarding of this US Patent for our transformational science is a significant milestone in the steps we have been taking to get our therapies to market."

Contact:

Contact: Patrick Casey

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Therapy Cells, Inc Receives USA Patent Granted for Revolutionary Cell Therapy

Understanding the basics of stem cell therapy (First Part)

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Understanding the basics of stem cell therapy (First Part)

DOH 11 conducts surveillance on stem cell facilities in Davao Region

DAVAO CITY The Department of Health is set to conduct a surveillance of all establishments in the Davao Region that are offering stem cell treatments without the proper authorization.

At present there are no facilities in the Region that have been authorized by DOH to perform stem cell treatments, DOH 11 Licensing Officer Alex F. Daba said.

He said so far two clinics located in the city have applied for authorization.

The move is in accordance with Administrative Order 2013-0012 providing the Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Cell-Based or Cellular Therapies in the Philippines which was released by Health Secretary Enrique T. Ona on March 18, 2013.

As with any new technology there is a need to regulate stem cell treatment in order to protect the public from unscrupulous people who might not be properly trained and authorized to conduct the procedure, he said.

Daba said they have received reports that even here in the region, there are facilities including hospitals and clinics conducting the stem cell therapy.

However, he added, they still have to verify those reports through the conduct of the surveillance.

As of now all we can do is to comply with the surveillance and then create a master list of these facilities. They are set to meet with the different hospitals and clinics in Davao next week to inform these facilities about the new guidelines so that they will discontinue providing the said treatments, he said.

With the issuance of Onas order, he said, all unauthorized facilities providing stem cell treatment are advised to stop.

The primary goal of the AO is to prevent the introduction, transmission and spread of communicable disease by ensuring a minimum quality of service rendered by hospitals and other health facilities in human stem cell therapies, he said.

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DOH 11 conducts surveillance on stem cell facilities in Davao Region

International Stem Cell Corporation Enters Into Clinical Research Agreement for Parkinson's Disease Program

CARLSBAD, CA--(Marketwired - Aug 21, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell-based therapies, announced today that it has entered into a master clinical research agreement with Duke University to conduct clinical trials research in Parkinson's disease using ISCO's innovative neural stem cell product.

Mark Stacy, M.D., Vice Dean for Clinical Research, Neurology at Duke University School of Medicine and an internationally recognized leader in the field of Movement Disorders, including Parkinson's disease, will be the study's principal investigator. The research will be coordinated by the Duke Clinical Research Institute (DCRI), the world's largest academic clinical research organization, which is internationally recognized for conducting groundbreaking clinical trials.

"We are pleased to have the opportunity to conduct the clinical trials related to ISCO's investigational stem cell therapy in Parkinson's disease patients," said Stacy. "Duke has an exceptional clinical trials team and we look forward to characterizing and understanding the safety and efficacy profile of this agent in the clinical trials setting."

"We're tremendously excited to be working with such a world-class clinical research organization as Duke University," commented Dr. Ruslan Semechkin, Vice President of Research and Development at International Stem Cell Corporation. "Dr. Stacy and his team have made numerous significant contributions in the field of Parkinson's disease research which together with Duke's extensive clinical expertise in cell therapy clinical trials and the extensive patient population, gives us an outstanding opportunity to evaluate our revolutionary stem cell therapy."

Stacy has extensive clinical trials experience, primarily involving neuro-protective and neuro-regenerative therapies and developing biomarkers for early diagnosis in Parkinson's disease. He has published more than 100 peer-reviewed scientific papers in the field and has served as an advisor to a number of companies. He has participated in more than 100 clinical trials.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells. The hPNSC are self-renewing mulitpotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (1) differentiate into dopaminergic neurons and (2) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new and revolutionary opportunity for the treatment of Parkinson's disease, especially in cases where current dopamine-replacement approaches fail to adequately control the symptoms.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products.ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos.ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com.

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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International Stem Cell Corporation Enters Into Clinical Research Agreement for Parkinson's Disease Program

BioTime CEO Dr. Michael West to Give Keynote Address at the MSC 2013 Adult Stem Cell Therapy & Regenerative Medicine …

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, announced that Chief Executive Officer Michael D. West, PhD will give the keynote address at the MSC 2013 Adult Stem Cell Therapy & Regenerative Medicine conference on Monday, August 19, 2013, at 12:15 p.m. EDT in Cleveland, Ohio. Dr. West will discuss the potential use of embryonic mesenchymal progenitor cells, generated using BioTimes PureStemtechnology, in regenerative medicine and will contrast the properties of those cells with adult-derived mesenchymal stem cells. He will also discuss how those cells can be utilized in the search for genes potentially useful in induced tissue regeneration (iTR). The presentation will be available on BioTimes website at http://www.biotimeinc.com/scientific-presentations.

MSC 2013 Adult Stem Cell Therapy & Regenerative Medicine, August 19-21, 2013, is being held at the Cleveland Marriott Downtown at Key Center and is presented by Case Western Reserve University and the National Center for Regenerative Medicine.

About BioTime, Inc

BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine. Regenerative medicine refers to therapies based on stem cell technology that are designed to rebuild cell and tissue function lost due to degenerative disease or injury. BioTimes focus is on pluripotent stem cell technology based on human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells. hES and iPS cells provide a means of manufacturing every cell type in the human body and therefore show considerable promise for the development of a number of new therapeutic products. BioTimes therapeutic and research products include a wide array of proprietary PureStem progenitors, HyStem hydrogels, culture media, and differentiation kits. BioTime is developing Renevia (a HyStem product) as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. In addition, BioTime has developed Hextend, a blood plasma volume expander for use in surgery, emergency trauma treatment and other applications. Hextend is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements.

BioTime is also developing stem cell and other products for research, therapeutic, and diagnostic use through its subsidiaries:

Additional information about BioTime can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com.

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BioTime CEO Dr. Michael West to Give Keynote Address at the MSC 2013 Adult Stem Cell Therapy & Regenerative Medicine ...

U of L explores stem cell treatment for chronic heart pain

LOUISVILLE, Ky. (WDRB) --It's cutting edge research happening in Louisville that could make a world of difference for people suffering from chronic heart pain.

On a mild Monday morning Harry Dennery walked a steady pace on a treadmill inside the Rudd Heart and Lung Center at Jewish Hospital in Downtown Louisville. Dennery said, "I've had heart issues for the last 22 years. I had open heart surgery and then had a triple bypass and three of the four of them closed up. Then I had a couple more stints put in and the last two time I was in the cath lab both of then were blocked 100 percent." After ten minutes on the treadmill at a steady pace and a slow incline the 68 year old could take no more. He said he experienced, "Shortness of breath, discomfort in the chest and tightening in the throat." This is exactly what his doctors wanted to see.

Dr. Michael Flaherty said, " Angina is chest pan coming from the heat and so we're trying to provoke angina to find out at which level that occurs with him now and compare that to later to see if there's an improvement." Dennery is one of the first people being screened for the third phase of clinical trials on the University of Louisville's Renew study. Dr. Flaherty and Dr. Roberto Bolli are researching whether stem cells harvested from a person's own blood can treat chronic heart pain - when injected directly into the heart muscle. Flaherty said, "These chest pain syndromes come from blockages in the top of the heart called the coronary arteries. There's a hope that this change in microenvironment will be able to reconstitute blood vessels where they're not able to deliver blood efficiently."

Reports say Angina affects approximately ten million people in the United States. It is most often caused by stress and physical exertion. This is the only study of its type in Kentucky and one of 50 in North America.

Dennery doesn't yet know if he'll receive the stem cells, a placebo, or standard care but after dealing with a troublesome heart over the better part of two decades and says the idea of a forever fix is enough to make him try. "Because my theory is as long as medical science advances faster than my heart deteriorates, I got a shot."

For more information on being screen for participation in the study contact Tina Collins, brcoll01@louisville.edu, clinical research coordinator, at 502-587-4106.

Copyright 2013 WDRB News. All rights reserved.

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U of L explores stem cell treatment for chronic heart pain

Stem Cells Market Will Reach USD 119.51 Billion in 2018: Transparency Market Research

Albany, NY (PRWEB) August 19, 2013

According to a new market report published by Transparency Market Research, Stem Cells Market (Adult, Human Embryonic , Induced Pluripotent, Rat-Neural, Umbilical Cord, Cell Production, Cell Acquisition, Expansion, Sub-Culture)- Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012 - 2018, the market for stem cells was valued at USD 26.23 billion in 2011 and is expected to reach an estimated value of USD 119.51 billion in 2018, growing at a CAGR of 24.2% from 2012 to 2018.

Related Report: Microscopy Devices Market http://www.transparencymarketresearch.com/microscopy-market.html

The market growth is majorly attributed to therapeutic research activities led by government support worldwide owing to the growing number of patients with chronic diseases across the globe. In addition, rising awareness of regenerative treatment options and growing importance of stem cell banking services are also fostering the growth of the market. Apart from these, development of medical tourism hubs in developing nations such as India and China and in turn migration of patients from developed nations such as the U.S. and Europe for quality treatment at significantly lower prices will also serve the market as a driver especially for the Asian stem cells market.

Related Report: Microscopes Market http://www.transparencymarketresearch.com/microscopes-market.html

The stem cells market will be driven by rising proportion of patients with neurological and other chronic conditions and rising disposable incomes of patients induced by economic growth of Asian regions in the next five years In addition, increasing dependence on stem cells for drug discovery and screening will boost the growth of the market in the future. Increased outsourcing of contract research and clinical trials to developing Asian regions will further encourage growth of the stem cells market.

Browse: http://udallas.academia.edu/transparencymarketresearch/Papers

Adult stem cells held majority share of the overall stem cells market in 2011 at over 80%. This is due to less laborious procedure of harvesting, and less probability of contamination during expansion and sub-culture of adult stem cells. However, fewer post-transplant complications and lesser risk of graft vs. host reaction from the recently introduced induced pluripotent stem cells will lead to its rapid inclusion in research activities and help the global induced pluripotent stem cells market to grow at a relatively faster CAGR during the forecast period.

Regenerative medicine dominated the stem cells market by applications in 2011, and is expected to maintain its leading position till 2018. Considerable research activities and the resultant developed therapies in neurology will drive the stem cells market in the forecast period.

Browse the full report with TOC at http://www.transparencymarketresearch.com/stem-cells-market.html/.

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Stem Cells Market Will Reach USD 119.51 Billion in 2018: Transparency Market Research

Stem cell mobilization now a reality

Inside Out By Cory Quirino Philippine Daily Inquirer

Stem cell therapy is the star of cutting-edge medical technology. Weve read about stem cell therapy but are confused about how it really works and why this special therapy should be considered for future use.

Every time the body is exposed to stress (i.e., a body part is injured), stem cells are automatically released to respond to the problem. Their mission is to repair and regenerate damaged cells. This is a biological event that alerts stem cells found in the blood, bone marrow adipose fat, brain, to take immediate action.

And whether one is sick (as in down with flu) or emotionally traumatized, stem cells still do their job of neutralizing and fixing the imbalances within the body.

However, when a person has a serious medical challenge, there may not be enough stem cells available to do the serious job of healing.

In short, available stem cell supply may not be effective to create a life-changing/saving impact.

The question is: How does one get enough stem cells in generous quantities to cause major healing?

There are methods used by clinics here and abroad to mobilize an army of stem cells. A chat with Dr. Samuel Bernal (tel. no. 9881000 loc. 6307/6551) proved enlightening as he said that stem cell mobilization is now no longer an impossibility, but a reality.

Daily habits matter

What you do every day can stimulate or delay stem cell activity.

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Stem cell mobilization now a reality

Stem Cell Markets

NEW YORK, Aug. 19, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Stem Cell Markets http://www.reportlinker.com/p090979/Stem-Cell-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy

A stem cell is an extraordinary type of cell that has the ability to self-renew for long periods of time and to differentiate into specialized cells under appropriate physiological or experimental conditions. Traditionally, stem cells have been classified as either embryonic, adult (tissue-specific or cord blood) stem cells. Recent understanding of stem cell biology may provide new approaches for the treatment of a number of diseases as well as tissue/organ injuries, including cardiovascular disease, neurological disease, musculoskeletal disease, diabetes and hematopoietic disorders. Stem cell fate is determined by both intrinsic regulators and the extra-cellular environment (niche), and their expansion and differentiation ex vivo are generally controlled by growing them in a specific configuration (monolayer or three-dimensional culture).

This process, which is vital to enable stem cells to be used for therapeutic purposes, is called differentiation. Differentiation is a process involving unspecialized cells progressing to become specialized cells with restricted developmental potential. The purpose of this TriMark Publications report is to describe the specific market segments of the medical research space using stem cells for research and development (R&D) purposes.

This study reviews all of the generally accepted analytical methods that are currently in use today for preparing and using stem cells. It examines the use of stem cells in developing new therapies for disease.

1. Overview 14

1.1 Statement of the Report 14 1.2 Scope of This Report 15 1.3 Methodology 15 1.4 Executive Summary 16

2. Biology of Stem Cells 20

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Stem Cell Markets