COFEPRIS leniency opens doors to stem cell therapies

NEW YORK, March 25, 2013 /PRNewswire/ --Celltex in Houston moved operations to Mexico early this year along with stem cell companies in India and China who have been inquiring about the Mexican market. According to ReHealth, COFEPRIS, which 2 years ago was closed to stem cell treatment has had a complete change of heart when they approached them again just about a month ago. ReHealth's core business is the development of autologous stem cells for diabetes types 1 and 2, COPD, cardiovascular diseases and sports injuries.

The Biopharma Mexico conference, from the 29th-30th October in Mexico City, will usher stem cell and regenerative medicine companies in the US , Europe and Asia into the Mexican market.

Join us and learn how to:

If you offer tools, consumables, reagents, products and services in stem cell development, contact us to find out how you can participate.

Biopharma Mexico will also bring together biotechs developing biologics, particularly bio-comparables and vaccines in the country.

Visit: http://www.terrapinn.com/biopharmamexico

About Terrapinn:

Terrapinn is a business media company. Our products are trade exhibitions, conferences, training solutions and electronic and print publications. More information and a schedule of our events can be found at http://www.terrapinn.com.

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COFEPRIS leniency opens doors to stem cell therapies

House advances bill requiring KU Medical Center to establish stem cell research center

Topeka A bill supported by abortion opponents that would require the Kansas University Medical Center to start a center on adult stem cell research was advanced by the House on Tuesday.

State Rep. David Crum, R-Augusta, described the bill as "pro-life," in that adult stem cell research has the "potential to establish cures that improve the quality of life and extend life."

But opponents of Senate Bill 199 said legislators shouldn't mandate KU start a center without any state funding while many of those same legislators also voted to cut funding to the school in the state appropriations bill.

And the opponents said KU did not ask for the bill and that traditionally the startup of a research and treatment center requires a lengthy planning process that brings together school leaders, researchers and the business community before approaching the Legislature.

"We are in uncharted territory," state Rep. Barbara Bollier, R-Mission Hills, said.

"Stem cell research and therapy is incredibly complex," Bollier said. "The doctors and researchers who are involved know what they are doing and they don't need us to set up a specific stem cell treatment center."

Bollier tried to add an amendment to the bill that she said was needed to tighten up legal issues on the research, but her proposal failed 40-74.

State Rep. Susan Concannon, R-Beloit, said it was proper for the Legislature to direct the universities.

"Maybe this would never happen because of the political questions involved," Concannon said. "The stem cell center would possibly never be built if not for the direction of the state."

The bill would require the KU Medical Center to establish the Midwest Stem Cell Therapy Center to advance adult, cord blood and related stem cell therapies.

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House advances bill requiring KU Medical Center to establish stem cell research center

New rules will regulate stem – cell therapy use

The Consumer By Linda Bolido Philippine Daily Inquirer

All the publicity about stem-cell therapy (SCT), including endorsements from some of the countrys most powerful people and brightest stars, has made it seem like a miracle cure, even a cure-all.

From the treatment of life-threatening medical problems to reversing the effects of aging, people are now beginning to look to SCTespecially if they can afford itfor salvation.

But, according to a doctor I know, there are actually only two proven applications for the therapy right now. The rest, at this stage, is really still experimental. People have, of course, volunteered for pioneering procedures, hoping for a cure for whatever ails them.

Education still needed

Thats well and good, as long as they are fully informed and give their unequivocal consent to being experimented on. The problem, however, is some people undergo the therapy without fully understanding it. And there are groups that seem to think that because they have Googled the therapy and read everything on the Net about it, they are capable of doing the procedure.

I mentioned in this column previously that even beauty parlors were offering to do SCT. Although it would be only for cosmetic purposes, the procedure is too new and complex to leave in the hands of beauticians.

Finally, the Department of Health has issued rules and regulations to regulate the SCT practice, a move warmly welcomed by the medical community, particularly the Philippine Medical Association and Philippine Society for Stem Cell Medicine, which expressed concern before that the popularity of SCT would lead to abuse and illegal practice if left unregulated.

Health Secretary Enrique Ona, in published reports, said the guidelines aimed to safeguard the welfare of our patients and the general public by making [sure] safe, effective and ethical stem-cell modalities and practices are within emerging international and global standards considering the very complex nature of this therapy.

Among other things, the rules restrict the use of genetically altered stem cells and tissues of human adults and the umbilical cord, fat-derived human stem cells and live animal stem cells.

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New rules will regulate stem - cell therapy use

Complete 2012-13 Induced Pluripotent Stem Cell Industry Report

DUBLIN, March 25, 2013 /PRNewswire/ --

Research and Markets has announced the addition of the "Complete 2012-13 Induced Pluripotent Stem Cell Industry Report" report to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )

Stem cell research and experimentation has been in process for well over five decades. Stem cells have the unique characteristics whereby they are able to divide and replicate repeatedly in addition to their being unspecialized with the ability to differentiate into specialized cell types. The possibilities that arise with the perfecting of cell replication has caused this area of exploration to remain on the forefront of scientific research, with ongoing hope that cures and treatment of diseases as well as reparative cell therapy, tissue regeneration and pharmacological testing on cell-specific tissue will one day become viable options within the medical community.

Traditionally, scientists have worked with both embryonic and adult stem cells. While the appeal of embryonic cells has been their ability to differentiate into any type of cell, there has been significant ethical, moral and spiritual controversy surrounding the use of embryonic cells for research. Although adult stem cells can differentiate slightly, they are typically limited to differentiation within their original tissue type, creating narrow options for their use.

Perhaps the most distinctive feature of this report are the breakthrough findings discovered as a result of surveying 293 researchers that identify as having induced pluripotent stem cells as their core research focus. Of the 293 respondents, 181 were U.S. based and 112 were international. These key survey findings reveal iPSC researcher wants and needs, technical preferences, and key factors influencing buying decisions. These vital findings can be used to direct the product development and product positioning decisions. Remember, to benefit from this lucrative product market, you need to anticipate and serve the needs of your clients, or your competitors will.

Key Findings Include:

- Charts, Timelines, Metrics and Financials for the iPSC Research Product Market

- Trends for iPSC Grants, Publications, Patents, and More

- 5-Year Market Projection Data for 2012-2017

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Complete 2012-13 Induced Pluripotent Stem Cell Industry Report

Stem cell treatment now available in Davao City

"STEM cell therapy is now in Davao City," announced by Dr. Luz P. Acosta, founding member of the Philippine Society for Stem Cell Medicine.

The stem cell treatment that is made available in the city is the internationally-recognized procedure approved by the Department of Health (DOH) and the Food and Drug Administration (FDA).

Acosta explained that the process starts with taking a collection of platelet-rich plasma (blood) and autologous adipose tissue (fat) from the patient.

From these, the stem cells are then isolated and activated through the use of machines technologically enhanced to perform such tasks.

She said the stem cells are then ready to be administered to the patient through local injections as needed. The whole process, she added, is done in approximately two to three hours, under local anesthesia. No hospital admission is required.

The body will not incur any adverse reactions, according to the medical expert, since only the patient's own cells are being used in the process, contrary to that of the controversial procedures which use fetal or animal stem cells that each pose ethical and religious issues or genetic and ancestral issues, respectively.

The revolutionary stem cell treatment, according to Acosta, has had documented success in the treatment of diabetes, autism, Alzeihmer's disease, liver cirrhosis, multiple sclerosis, erectile dysfunction, kidney diseases, and lung diseases.

"There is no longer a need for Dabawenyos to go out of the country or fly to Manila to receive treatment for various diseases which had previously rendered patients desperate and hopeless." Acosta said.

Published in the Sun.Star Davao newspaper on March 27, 2013.

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Stem cell treatment now available in Davao City

ViaCord Releases 250th Cord Blood Stem Cell Unit

WALTHAM, Mass.--(BUSINESS WIRE)--

ViaCord, PerkinElmers family cord blood and tissue preservation business, announced today the release of its 250th umbilical cord blood stem cell unit for use in medical treatments and clinical trials. For nearly 20 years, ViaCord has released life-saving stem cells for disease therapies using a proven method of processing and cryopreserving cord blood. To date, ViaCord has released more units for use in medical treatments and clinical trialsthan any other family bank.

Reaching this milestone is a testament to our dedication to improving the quality of life for families, said Morey Kraus, Chief Scientific Officer, ViaCord. The benefits of cord blood banking are constantly evolving as research, some of which ViaCord has been instrumental in supporting, continues to expand the number of diseases treated. We are excited to continue to assist families who have chosen to bank their newborns stem cells.

Cord blood stem cells have been used in the treatment of nearly 80 diseases, and more than 30,000 treatments have been conducted worldwide using cord blood stem cells. ViaCord has released stem cells for the treatment of diseases ranging from acute lymphoblastic leukemia, thalassemia major and sickle cell disease. ViaCords 250th unit was used to treat a patient currently enrolled in the Duke Translational Medicine Institutes Cerebral Palsy Autologous Cord Blood clinical trial conducted at Duke University Medical Center. In this clinical trial, researchers are investigating the potential benefits of autologous reinfusion of cord blood stem cells for children with cerebral palsy.

ViaCord has preserved the umbilical cord stem cells of more than 300,000 newborns. ViaCords family cord blood and cord tissue services currently offer expectant families the opportunity to bank their baby's umbilical cord blood and tissue for potential medical use by the child or a related family member. Through its Sibling Connection Program, ViaCord also provides the opportunity for expectant parents, who have an eligible child in need of a transplant, to receive cord blood and cord tissue stem collection, processing and five years of storage, at no cost.

Please visit http://www.viacord.com for more information.

About PerkinElmer, Inc. PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The company reported revenue of approximately $2.1 billion in 2012, has about 7,500 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at http://www.perkinelmer.com.

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ViaCord Releases 250th Cord Blood Stem Cell Unit

Howard Leonhardt to Present 25 Years of Experience With Stem Cell Transplantation at 28th Annual Interventional …

SNOWMASS, Colo., March 26, 2013 /PRNewswire/ -- Howard Leonhardt of Bioheart, Inc., and Leonhardt Ventures will be presenting his team's experience with stem cell transplantation at the 28th Annual International Symposium of Interventional Cardiology. The conference, which will explore a comprehensive approach to the percutaneous management of structural heart disease and coronary and peripheral vascular disease, will be held at the Westin Hotel in Snowmass Village, Colo., from March 24 - 29, 2013. Leonhardt's presentation, titled "25 Years' Experience With Myoblast Transplantation" and listed as Oral Abstract Session VI in the program, will take place Thursday, March 28, from 7 - 10 a.m.

Over the past 25 years, Bioheart's research and trials in stem cell transplantation for treating heart failure have revealed the following:

For more information on the 28th Annual International Symposium of Interventional Cardiology, see http://www.interventionalcardiol.com. To learn more about Bioheart's advances in regenerative medicine, visit http://www.bioheartinc.com.

About Leonhardt Ventures: Since 1983 Leonhardt Ventures http://www.leonhardtventures.com has a strong history of inventing, developing, backing and bringing to market leadership products for treating heart and cardiovascular disease. Over 200,000 patients have been treated to date with Leonhardt inventions. In the 1980s, the group developed market leadership in patented polyurethane balloon catheters including drug, stem cell and radiation delivery systems. In the 1990s, they developed over 20 additional devices including the first commercially successful stent graft for aortic aneurysm repair (TALENT Taheri-Leonhardt Stent Graft). The team completed the first ever truly percutaneous repair of an aortic aneurysm without surgery in Melbourne, Australia, in 1995, and published the first paper on thoracic aortic dissection repair with stent grafts in The New England Journal of Medicine in 1999. Other firsts for the team include the first conformance-sealing stent graft, the first above renal fixation stent graft, the first customized-to-fit individual patient stent grafts, the first multi-stage low-profile stent graft, the first removable stent graft, the first foam and bioglue sealing cuff for stent grafts, and the first use of muscle stem cells to reinforce aortic wall necks after stent graft placement. The team developed and patented the first percutaneous heart valve, intravascular lung catheter, the Pro-Cell intracavity stem cell delivery system and the MyoCath line of stem cell delivery catheters. Leonhardt-patented inventions include the first heart pacemaker able to recruit repairative stem cells to damaged heart tissue (MyoStim Pacers). In 2001, the team led the world's first non-surgical case of stem cell repair of damaged heart muscle in a human patient with Bioheart MyoCell. That led to the first Phase III double-blinded, randomized, placebo-controlled trial for stem cells growing new contractile muscle in post-heart-attack tissue in advanced heart failure patients, with results published in the American Heart Journal: Bioheart MyoCell resulted in 95.7 meters improvement in exercise capacity over placebo (minus 4 meters decline). The team is preparing to complete the first-ever biological pacemaker implantation in a human patient within the next 12 months (BioPace).

About Bioheart, Inc.Bioheart is focused on completing its Phase II/III MARVEL study for MyoCell in treating advanced heart failure. The product candidate has been in clinical trials since May 2001. The company believes, after 10 years of clinical trials that followed pre-clinical studies dating to 1988, that it may be on the final leg toward qualifying to apply for a biologics license-approval FDA panel review. Approximately 130 more patients are needed in the randomized, double-blinded, placebo-controlled MARVEL Phase II/III Part II study. MyoCell is a clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the intended purpose of improving cardiac function and quality of life in chronic heart failure patients.

For more information on Bioheart, visit http://www.bioheartinc.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2012, and its Quarterly Reports on Form 10-Qs.

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Howard Leonhardt to Present 25 Years of Experience With Stem Cell Transplantation at 28th Annual Interventional ...

Stem – cell ruling riles researchers

A naked woman joined protesters in Rome calling for stem-cell therapy for all incurably ill patients.

Benvegn/Guaitoli/Cimaglia/Jpeg FOTOSERVIZI

Clinics that offer unproven stem-cell treatments often end up playing cat and mouse with health regulators, no matter which country they operate in. In Italy, however, one such treatment now has official sanction. The countrys health minister, Renato Balduzzi, has decreed that a controversial stem-cell treatment can continue in 32 terminally ill patients, mostly children even though the stem cells involved are not manufactured according to Italys legal safety standards.

The unexpected decision on 21March has horrified scientists, who consider the treatment to be dangerous because it has never been rigorously tested. In the opinion of stem-cell researcher Elena Cattaneo of the University of Milan: It is alchemy.

The decision followed weeks of media pressure to authorize compassionate use of the therapy, which was developed by the Brescia-based Stamina Foundation and has been repeatedly banned in the past six years. Now, patient groups are pushing for the treatment to be available to anyone with an incurable illness. Hundreds protested in Rome on 23March, including a naked woman with pro-Stamina slogans painted on her skin.

Stamina Foundation president Davide Vannoni, a psychologist at the University of Udine, says that the publicity around the treatment has won him 9,000 new patients. He hopes that further modifications to the law will allow him to expand the therapy.

A month ago, an investigatory television programme, The Hyena, reported that children with incurable diseases such as spinal muscular atrophy were being denied supposedly important treatment, and Italian show-business personalities joined the call to relax rules on stem-cell treatment.

In Italy, the compassionate use of as-yet-unapproved therapies is allowed on an emergency basis for dying individuals who have no other options, and the national health service must provide them for free. The law requires that health authorities approve the quality of such therapies, but some of its terms are ambiguous, says Amedeo Santosuosso, a Milanese judge and a professor at the University of Pavia who specializes in science and law. That has been the underlying problem in the Stamina debacle, he says. In the case of the Stamina Foundation therapy, there is no suggestion that it might be efficacious, so in my opinion compassionate use is not legitimate.

Vannoni says that he developed the therapy after having successful stem-cell treatment for a virus-induced facial paralysis in 2004 in Russia. He invited a Russian and a Ukrainian scientist to Turin to develop the method and says that Stamina has since treated 80 or so patients including people with Parkinsons disease, Alzheimers and muscle-wasting disorders. He has not published the outcomes or precise details of his therapy, which uses the mesenchymal stem cells from bone marrow that differentiate into bone, fat and connective tissue. In his protocol, the cells are extracted from patients, manipulated in the laboratory and then re-infused.

Vannoni acknowledges that he has not published outcomes but says that the method is far from alchemy. Each treatment uses five types of cell, he explains, with their claimed characteristics tuned to replace damaged tissue or to secrete molecules that could reduce inflammation, fight infection or promote blood-vessel growth. Whatever the disease, one of the types of cell is going to have the right effect, he says.

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Stem - cell ruling riles researchers

Amniotic fluid stem cells repair gut damage

Public release date: 24-Mar-2013 [ | E-mail | Share ]

Contact: Jenny Gimpel jenny.gimpel@gosh.org 44-020-723-93043 University College London

Stem cells taken from amniotic fluid were used to restore gut structure and function following intestinal damage in rodents, in new research published in the journal Gut. The findings pave the way for a new form of cell therapy to reverse serious damage from inflammation in the intestines of babies.

The study, funded by Great Ormond Street Hospital Children's Charity, investigated a new way to treat necrotizing enterocolitis (NEC), where severe inflammation destroys tissues in the gut. NEC is the most common gastrointestinal surgical emergency in newborn babies, with mortality rates of around 15 to 30 per cent in the UK.

While breast milk and probiotics can help to reduce the incidence of the disease, no medical treatments are currently available other than surgery once NEC sets in. Surgical removal of the dead tissue shortens the bowel and can lead to intestinal failure, with some babies eventually needing ongoing parenteral nutrition (feeding via an intravenous line) or an intestinal transplant.

In the study, led by the UCL Institute of Child Health, amniotic fluid stem (AFS) cells were harvested from rodent amniotic fluid and given to rats with NEC. Other rats with the same condition were given bone marrow stem cells taken from their femurs, or fed as normal with no treatment, to compare the clinical outcomes of different treatments.

NEC-affected rats injected with AFS cells showed significantly higher survival rates a week after being treated, compared to the other two groups. Inspection of their intestines, including with micro magnetic resonance imaging (MRI), showed the inflammation to be significantly reduced, with fewer dead cells, greater self-renewal of the gut tissue and better overall intestinal function.

While bone marrow stem cells have been known to help reverse colonic damage in irritable bowel disease by regenerating tissue, the beneficial effects from stem cell therapy in NEC appear to work via a different mechanism. Following their injection into the gut, the AFS cells moved into the intestinal villi - the small, finger-like projections that protrude from the lining of the intestinal wall and pass nutrients from the intestine into the blood. However, rather than directly repairing the damaged tissue, the AFS cells appear to have released specific growth factors that acted on progenitor cells in the gut which in turn, reduced the inflammation and triggered the formation of new villi and other tissues.

Dr Paolo De Coppi, UCL Institute of Child Health, who led the study, says: "Stem cells are well known to have anti-inflammatory effects, but this is the first time we have shown that amniotic fluid stem cells can repair damage in the intestines. In the future, we hope that stem cells found in amniotic fluid will be used more widely in therapies and in research, particularly for the treatment of congenital malformations. Although amniotic fluid stem cells have a more limited capacity to develop into different cell types than those from the embryo, they nevertheless show promise for many parts of the body including the liver, muscle and nervous system."

Dr Simon Eaton, UCL Institute of Child Health and co-author of the study, adds: "Once we have a better understanding of the mechanisms by which AFS cells trigger repair and restore function in the gut, we can start to explore new cellular or pharmacological therapies for infants with necrotizing enterocolitis."

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Amniotic fluid stem cells repair gut damage