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

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

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

St. Luke’s qualifies use of stem cell therapies

Researches ongoing for Alzheimers disease, cancer

MANILA, Philippines -- St. Lukes said it will only endorse and make available established and safe stem cell therapies that have undergone rigorous, long-term clinical research.

The hospital is also now in the midst of gathering data on stem cell treatments through clinical research. It is also starting to establish guidelines in the use of stem cells derived from adult skin, fat, bone marrow, and other possible sources to address various medical conditions.

Our institution at this time will use stem cells as a standard treatment only when there is data to show its clinical outcomes, its safety features, said Dr. Joven R. Cuanang, St. Lukes senior vice president for medical affairs and chief medical officer.

This, amid the proliferation of stem cell therapies have in the Philippines that promise a virtual cure for a plethora of medical conditions from arresting aging to improving libido, as well as healing what were once considered incurable diseases such as cancer or degenerative diseases such as Parkinsons disease, diabetes, and multiple sclerosis, among others.

Nonetheless, these treatments may be harmful since they have yet to pass extensive clinical trials.

At present, St. Lukes Stem Cell Center uses stem cell as a standard of care for leukemias such as acute leukemia, chronic myolegenous leukemia, and myelodysplastic syndrome; myeloma; lymphomas; non-malignant hematologic diseases, and other bone marrow diseases.

The St. Lukes International Eye Institute also treats some ocular surface diseases using stem cells.

All other disease indications for stem cell and gene therapy remain to be on a clinical research level, as there are no long term studies, even abroad, to present to patients who are seeking them out, Cuanang said.

The hospital has also been able to establish clinical protocols for Alzheimers disease and spinal cord injuries. It said the results will be presented to the public when sufficient data has been gathered.

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St. Luke's qualifies use of stem cell therapies

Stem cell therapy–how profitable?

By Amads Ma. Guerrero Philippine Daily Inquirer

INFORMATION booth

You feel like you have entered an attractive boutique hotel in miniature; everything is neat, clean, almost spotless and sparkling.

This is the Asian Aesthetic Center in Katipunan Avenue, Quezon City (contact number: 7099565) across the Ateneo de Manila. The equipment is state-of-the-art, and there are two main wings: The Dermatology Wing and the Surgical Wing.

In the Dermatology Wing we have a Laser Room, Slimming Room, a Wellness Room and a Facial Treatment Room. The Surgical Room was what interested me mostbut only as a writer and not personally, because my cells are not dysfunctional (to my knowledge!).

Unfortunately, colleague Neilsen and I could not enter the Surgical Wing because a procedure was under way. In this wing, we were told, is a stem cell laboratory unit with the stem cell extractor and activator machines, and a recovery room, along with other amenities.

The clinic is cozy and family-run, you might say. It is headed by Dr. Amy B. Tinaza, a cosmetic surgeon and a stem cell specialist, and her partner (professional as well as personal) Dr. Jomar S. Tinaza, chief facial plastic surgeon and her husband. And the centers PR is a sister in law, Charlotte Tinaza.

The Tinaza couple head the Stem Cell Therapy Team, and there are also Medical, Surgical, Specialist and After-Care Teams.

So why did she (Dr. Amy) choose to be a stem cell specialist? Although stem cell therapy is at an early stage, I believe it is the future of medicine, she replies.

The centers stem cell therapy is the Autologous Fat Stem Cell, in which the stem cell is from the fat cells of the same patient, and transferred back to the patient once the stem cell is activated.

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Stem cell therapy–how profitable?

Judges side with FDA in rejecting stem cell device

WASHINGTON (AP) -- A federal appeals court has sided with the Food and Drug Administration in a case brought by medical device maker Cytori, ruling that the agency was correct to reject fast-track approval for two company devices used to process adult stem cells.

Cytori Therapeutics Inc. makes the Celution and StemSource devices which separate adult stem cells from fat tissue using a combination of spinning motions and chemical reactions. The company is studying the technology for a variety of medical uses, including breast reconstruction, burn healing and treating damaged heart tissue. The technology has even been adopted by some plastic surgeons, who claim adult stem cells can be injected into the face, breast and other areas to create a younger look.

Medical devices cannot be marketed in the U.S. without prior approval by the FDA.

Cytori asked the FDA in 2011 to approve the Celution and StemSource devices using a fast-track pathway reserved for devices that are similar to products already on the market. Cytori argued that its technology is similar to that used to process cells from blood and bone marrow.

The FDA rejected that argument and told the company it would need to apply through a more rigorous process that involves large studies with human participants.

A three-judge panel backed that decision in a ruling issued Friday.

"FDA concluded and explained that fat is not blood and that the difference matters. A court is ill-equipped to second-guess that kind of agency scientific judgment," states the opinion, written by Judge Brett Kavanaugh. "After careful review, we find FDA's assessment both reasonable and reasonably explained."

The ruling was signed by fellow Judges Janice Rogers Brown and David Sentelle of the U.S. Court of Appeals for the District of Columbia.

The judges noted that the study Cytori submitted to the FDA for approval included only 12 patients, too small for regulators to evaluate the safety and effectiveness of the technology.

Cytori downplayed the significance of the ruling Friday in an interview with The Associated Press, saying the company had effectively abandoned the shortcut approval pathway, known as the 510k process.

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Judges side with FDA in rejecting stem cell device

Catholic Church gives blessing to stem cell research

In the past 20 years, stem cell research has been thrust into the medical spotlight as celebrities like Michael J. Fox and Christopher Reeve have advocated for it. Also, numerous studies have shown stem cell therapies have successfully treated a plethora of diseases.

And now, with the release of The Healing Cell: How the Greatest Revolution in Medical History Is Changing Your Life, the Catholic Church has given its stamp of approval on adult stem cell research by discussing the many ways these therapies work for the greater good. In fact, Pope Emeritus Benedict XVI wrote the books introduction, which was co-authored by Dr. Robin Smith and Monsignor Tomasz Trafny, along with Max Gomez.

Stem cell therapy isnt anything new. Using bone marrow transplants to treat leukemia, which started more than 40 years ago, is essentially the same procedure. Through this process, doctors extract stem cells from the bone marrow and transplant them into the body to replace damaged cells caused by blood and bone marrow cancers. Sometimes cancer patients use autologous cells cells harvested from their own body and sometimes they use donated cells from another persons bone marrow.

Ethical concerns

Smith said when celebrities began speaking out on behalf of embryonic super cells, thats when the real buzz started.

Embryonic stem cells can become anything, any organ, Smith said. You have to destroy the embryo to get the cells, unless its from a stillborn fetus. Its hard to control that in a lab. So thats a little different from an adult stem cell, which is more mature. They exist in our bodies throughout our lifetime and go on to create just one or two specific things. All these clinical trials are looking at what cells should come from and where, in order to be treated.

Embryonic stem cells are derived from unused embryos initially intended for in vitro fertilization. However, because of the sheer number of embryos actually created and stored, there are many ultimately slated for destruction.

The ethical concerns come from whether or not to use embryonic stem cells for research. Some people and organizations, including the Catholic Church, feel even though these cells come from blastocysts, it is still destroying human life.

Scientists often counter-argue that if these embryos are going to be destroyed anyway why not put them to use for research and medicinal treatment?

Smith noted that currently, there are 4,300 adult stem cell trials, and only 26 embryonic stem cell trials.

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Catholic Church gives blessing to stem cell research

Cytori Loses Bid to Overturn FDA Bar on Stem – Cell Devices

Cytori Therapeutics Inc. (CYTX), a biotechnology company developing experimental burn treatment therapies, lost a U.S. appeals court bid to overturn the Food and Drug Administrations initial rejection of two medical devices that use fat as a source of stem-cell therapy.

The U.S. Court of Appeals in Washington upheld the FDAs decision that two devices submitted by Cytori for approval required more extensive testing before they could be released safely on the market.

The devices, called Celution and StemSource, arent substantially equivalent to currently marketed devices, which rely on blood or marrow cells, U.S. Circuit Judge Brett Kavanaugh wrote today in the 12-page opinion.

The FDA reasonably concluded and reasonably explained that the Celution and StemSource did not meet either the intended use requirement or the technological characteristics requirement for a substantial equivalence determination, Kavanaugh said in a ruling joined by circuit judges Janice Rogers Brown and David Sentelle.

In order to win approval for new medical devices through a more streamlined premarket notification process, the devices have to be similar to others already on the market and have similar uses, Kavanaugh said.

Cytori shares fell as much as 3 percent on the news before recovering to $2.77 in New York trading, unchanged from yesterdays close.

Cytoris experimental therapy takes adipose tissue, or body fat, from a patient and through its device separates the adult stem and regenerative cells. The San Diego, California-based company last year won a $4.7 million U.S. government contract to develop a stem cell therapy to treat burns caused by thermal or radioactive bombs.

Testing the technology in a clinical trial and getting approval may take five years, Chief Executive Officer Christopher Calhoun said in an interview with Bloomberg Television Sept. 28. The company is testing its therapy for other soft tissue damage, as well as cardiovascular disease, Calhoun said.

To contact the reporter on this story: Sara Forden in Washington at sforden@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

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Cytori Loses Bid to Overturn FDA Bar on Stem - Cell Devices