StemCell Therapy

By David Cyranoski of Nature magazine

With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company.

The US Food and Drug Administration (FDA) has not approved any such stem-cell treatment for routine clinical use, although it does sanction them for patients enrolled in registered clinical trials. Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction.

There are certainly plenty of people eager to have the treatments. Texas governor Rick Perry, for instance, has had stem-cell injections to treat a back complaint, and has supported legislation to help create banks to store patients' harvested stem cells.

One company that has benefited from this buoyant climate is Celltex Therapeutics, which "multiplies and banks" stem cells derived from people's abdominal fat, according to chairman and chief executive David Eller. Its facility in Sugar Land, just outside Houston, opened in December 2011 and houses the largest stem-cell bank in the United States.

Celltex was founded by Eller and Stanley Jones, the orthopaedic surgeon who performed Perry's procedure, and it uses technology licensed from RNL Bio in Seoul. Because clinical use of adult-stem-cell treatments are illegal in South Korea, RNL has since 2006 sent more than 10,000 patients to clinics in Japan and China to receive injections.

Celltex says that although it processes and banks cells, it does not carry out stem-cell injections. It declined to answer Nature's questions about whether its cells have been used in patients. But there is evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases.

Public hype

In addition to the publicity surrounding Perry's treatment, a woman named Debbie Bertrand has been blogging about her experiences during a five-injection treatment with cells prepared at Celltex. Her blog (http://debbiebertrand.blogspot.com) hosts photographs of herself alongside Jones; Jennifer Novak, a Celltex nurse; Jeong Chan Ra, chief executive of RNL Bio; and her doctor, Jamshid Lotfi, a neurologist who works for the United Neurology clinic in Houston. Another photo is captioned: "My cells are being processed in here for my next infusion!!!" A third shows Bertrand, Lotfi and a physician called Matthew Daneshmand, who is, according to the caption, injecting Bertrand's stem cells into an intravenous drip, ready for the infusion. Nature has been unable to contact Bertrand.

Lotfi says that he has administered cells processed by Celltex to more than 20 people. "Five or six" -- including Bertrand -- have multiple sclerosis and "four or five" have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat -- containing roughly 100,000 mesenchymal stem cells -- from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection.

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Stem-Cell Therapy Takes Off in Texas

Women may make new eggs throughout their reproductive yearschallenging a longstanding tenet that females are born with finite supplies, a new study says. The discovery may also lead to new avenues for improving women's health and fertility.

A woman has two ovaries, which release eggs during her monthly ovulation.(Learn more about the human body.)

Previous research had suggested that a woman is born with all the egg cells she will ever have in her lifetime.

But in recent experiments, scientists discovered a new type of stem cell in the ovaries thatwhen grown in the labgenerates immature egg cells.The same immature cells isolated from adult mouse ovaries canturn into fertile eggs.

Stem cells,found in embryos and certain adult body tissues, have the potential to grow into many different types of cells.

(See"Liposuction Fat Turned Into Stem Cells, Study Says.")

The finding reinforces the team's previous experiments in mice, which had identified a new type of ovarian stem cell that renews a female mouse's source of eggs throughout its fertile years.

That study, published in the journal Nature in 2004, was the "first to reach the conclusion that this long-held belief in our fieldthat young girls are given a bank account at birth that you can no longer deposit eggs to, just withdraw fromwas no longer true," said study leaderJonathan Tilly.

By reinforcing these earlier results in people, the new study is a "big step forward" from the mouse work, emphasized Tilly, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital in Boston.

From a purely biological perspective, the concept that a woman would continually generate new eggs during her reproductive years makes sensesince men constantly replenish their sperm, Tilly added. (Read how men produce 1,500 sperm a second.)

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Women Can Make New Eggs After All, Stem-Cell Study Hints

SUNRISE, Fla., Feb. 28, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced that the company will conduct the ANGEL trial using adipose (fat) derived stem cell technology or LipiCell(TM) at the University of Miami Miller School of Medicine. Bioheart recently applied to the FDA to begin trials using adipose derived stem cells in patients with chronic ischemic cardiomyopathy.

"Dr. Joshua Hare and the University of Miami are world leaders in the field of stem cell research," said Mike Tomas, President and CEO of Bioheart. "We look forward to working with these acclaimed experts and bringing the LipiCell(TM) technology to patients in the U.S."

The clinical protocol of the ANGEL trial is designed to assess the safety and cardiovascular effects of intramyocardial implantation of autologous adipose derived stem cells (LipiCell(TM)) in patients with chronic ischemic cardiomyopathy. Joshua Hare, MD, Director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine is the principle investigator of the clinical program.

The Interdisciplinary Stem Cell Institute was established to capitalize on pioneering work in the use of adult stem cells for the repair of malfunctioning human organs. The goal of the Institute is to find new treatments for heart disease, neurological disease, bone disease, diabetes, cancer, eye diseases and other chronic, debilitating, or incurable diseases. University of Miami scientists have led in the development of procedures to extract adult stem cells and have conducted ground breaking research in cell-based therapy for the diseased human heart.

About Bioheart, Inc.

Bioheart is committed to maintaining our leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Our goals are to cause damaged tissue to be regenerated, if possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, we are focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Our leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function 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, 2010, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.

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Bioheart Announces University of Miami as Clinical Site for ANGEL Trial of LipiCell(TM)

Contrary to the belief that women are born with a finite number of eggs, there may in fact be a way to replenish the supply, a new study suggests.

Researchers have isolated stem cells from adult human ovaries that appear to be capable of producing eggs.

The new findings follow a number of recent studies that have suggested such stem cells exist in adult mice, and can give rise to healthy offspring in animals that have had their fertility destroyed by chemotherapy. However, these studies have been controversial, because they go against years of research suggesting otherwise, experts say.

In the new study, the researchers devised a more rigorous way to isolate these cells, and for the first time, suggested their existence in people.

If true, the findings could have  implications for women's fertility treatments. Currently, women who choose to undergo in vitro fertilization (IVF) for infertility must endure hormone injections so doctors can retrieve eggs for fertilization, said study researcher Jonathan Tilly, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital. But if researchers could isolate egg-producing stem cells from ovaries, it might be possible to conduct that whole process outside the body, Tilly said.

"That whole program of IVF… becomes a non-necessity," Tilly said.

The study is published online today (Feb. 26) in the journal Nature Medicine.

Egg stem cells

In the new study, Tilly and colleagues isolated egg-producing stem cells from human ovary tissue by targeting a protein found on the surface of only these cells. In dishes, the cells grew into cells that had properties of human eggs. For instance, they had half the genetic material of other cells in the body.

Next, to show the stem cells could produce eggs, the researchers placed a gene into the stem cells that made them glow green, placed the stem cells into human ovarian tissue (taken during a biopsy), and grafted this tissue into mice. One to two weeks later, this tissue contained egg cells glowing green, showing they had formed from the stem cells, the researchers said.

The researchers don't yet know if these egg cells could be fertilized to produce children. The United States does not allow human eggs to be fertilized for research purposes. The researchers also don't know whether these egg-producing stem cells are active throughout a woman's life, or only when they receive a particular signal, Tilly said, although the researchers have a follow-up study planned to address this question.

The number of egg-producing stem cells appear to be quite minute. In mice, they make up about 0.014 percent of all cells in the ovary, Tilly said.

Still a controversy

"It's very novel and it's very exciting," said Dr. Sandra Carson, professor of obstetrics and gynecology, at Brown University's Women & Infants Hospital, who was not involved in the study.

"It certainly makes sense that there would be those stem cells still there," said Carson, noting men have stem cells that produce sperm throughout life.

However, other researchers say the new paper does not resolve the controversy of whether egg-producing cells exist in adult ovaries.

"I would like to see better characterization of this very small pool of cells that may be present in the ovary," said Dr. Marco Conti, professor and director of the Center for Reproductive Sciences at the University of California, San Francisco. Conti noted that some properties of the egg-producing cells described in this study do not match descriptions from previous studies.

And the paper still does not address whether these cells have any role in adult humans.

"There is no real functional evidence that this pool of cells indeed contributes to [egg formation] in the adult," Conti said.

But if these cells do in fact work in the way the researchers suspect, it might be possible to grow and mature them in an environment that resembles an ovary, Carson said.

In addition, unlike human eggs, these stem cells can be frozen without damage, Tilly said, so it may be possible to store them for future use.

Tilly is a co-founder of OvaScience, Inc, which has licensed the commercial potential of these findings for development of new fertility-enhancing procedures.

Pass it on:  Women's ovaries may contain stem cells that are capable of producing eggs after birth.

This story was provided by MyHealthNewsDaily, a sister site to LiveScience. Follow MyHealthNewsDaily staff writer Rachael Rettner on Twitter @RachaelRettner. Find us on Facebook.

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Stem Cells in Women's Ovaries May Produce New Eggs, Study Finds

Heston Blumenthal is set to serve up a 207,000 'test-tube' burger later this year.

The tasty meal will be the first beef patty ever created in the laboratory thanks to the efforts of Dutch stem cell scientist Dr Mark Post, from the University of Maastricht.

Speaking at the annual meeting of the American Association for the Advancement of Science (AAAS) in Vancouver, Canada, Dr Post said: 'In October we're going to provide a proof-of-concept showing that with in-vitro methods, out of stem cells we can make a product that looks like and feels and hopefully tastes like meat.

'That first hamburger is going to cost 250,000 euros.'

After experiments which progressed from mouse meat to pork, it will make a grand public entrance in October.

The current plan is for Blumenthal to cook it for a mystery guest, to be chosen by the research project's anonymous funder.

The minced meat will have been grown from bovine muscle and fat stem cells cultured in Dr Post's laboratory.

Currently Dr Post is still working with unappetising half-millimetre thick strips of lab-grown meat that are pinky-yellow in colour.

But he is confident that over the course of this year he will produce a burger virtually indistinguishable from one bought in the high street.

The research has a serious aim - to address the problem of unsustainable livestock farming.

'These animals are very inefficient in the way they convert vegetable matter to animal protein,' he said.

Test Tube Burger Is 'Petri Dish' Of The Day

1 Comments

The research aims to address the problem of unsustainable livestock farming

3:57am UK, Monday February 20, 2012

Heston Blumenthal is set to serve up a 207,000 'test-tube' burger later this year.

The tasty meal will be the first beef patty ever created in the laboratory thanks to the efforts of Dutch stem cell scientist Dr Mark Post, from the University of Maastricht.

Speaking at the annual meeting of the American Association for the Advancement of Science (AAAS) in Vancouver, Canada, Dr Post said: 'In October we're going to provide a proof-of-concept showing that with in-vitro methods, out of stem cells we can make a product that looks like and feels and hopefully tastes like meat.

'That first hamburger is going to cost 250,000 euros.'

After experiments which progressed from mouse meat to pork, it will make a grand public entrance in October.

The current plan is for Blumenthal to cook it for a mystery guest, to be chosen by the research project's anonymous funder.

The minced meat will have been grown from bovine muscle and fat stem cells cultured in Dr Post's laboratory.

Currently Dr Post is still working with unappetising half-millimetre thick strips of lab-grown meat that are pinky-yellow in colour.

But he is confident that over the course of this year he will produce a burger virtually indistinguishable from one bought in the high street.

The research has a serious aim - to address the problem of unsustainable livestock farming.

'These animals are very inefficient in the way they convert vegetable matter to animal protein,' he said.

'Cows and pigs have an efficiency rate of about 15%, which is pretty inefficient. Chickens are more efficient and fish even more.

'Meat demand is going to double in the next 40 years. Right now we are using 70% of all our agricultural capacity to grow meat through livestock.

'You can easily calculate that we need alternatives. If you don't do anything meat will become a luxury food and be very, very expensive.'

In time, he expected the cost of test-tube meat to be brought down to affordable levels. It may then present consumers with the same kind of choice they currently have between buying battery farm or free range eggs.

The process of making test tube meat involves first obtaining the stem cells and allowing them to proliferate around 30-fold. Every muscle cell is accompanied by four or five stem cells.

The stem cells are grown in a culture medium containing all the nutrients and vitamin 'food' they need.

To construct three dimensional tissue, the cells are mixed with a collagen gel in a culture dish containing velcro 'anchor points'.

Between the anchor points, they self-organise into fully-fledged chunks of muscle. An important step is to make them contract using electrical stimulation.

Finally the beef strips are harvested, minced up, and moulded into a patty. To make the burger more realistic, the muscle meat is mixed with fat grown the same way from a different kind of stem cell.

Three thousand pieces of muscle are combined with around 200 pieces of fat.

Dr Post refuses to reveal the identity of the private individual financing the research, who wants to remain anonymous.

But he said he was a well known figure with 'deep pockets'.

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Test-tube burger 'petri dish' of the day

Celebrity chef Heston Blumenthal is the favourite to cook the $A250,000 hamburger made from stem cells.

THINKSTOCK

THE world's first hamburger made with a synthetic meat protein derived from bovine stem cells will be publicly consumed this October after being prepared by a celebrity chef, according to the inventor of the artificial mince.

Heston Blumenthal is the favourite to be asked to cook the $250,000 hamburger, which will be made from 3,000 strips of synthetic meat protein grown in fermentation vats.

Dr Mark Post, of Maastricht University in the Netherlands, said the anonymous backer of his research project had not yet decided who would get to eat the world's most expensive hamburger, which will unveiled at a ceremony in Maastricht.

Dr Post told the American Association for the Advancement of Science that a hamburger made from artificial beef protein was a milestone in the development of novel ways to meet the global demand for meat, which is expected to double by 2050.

"In October we're going to provide a 'proof of concept' showing that with in vitro culture methods that are pretty classical we can make a product out of stem cells that looks like, and hopefully taste like, meat," Dr Post said.

"The target goal is to make a hamburger and for that we need to grow 3,000 pieces of this muscle and a couple of hundred pieces of fat tissue. As long as it's a patty the size of a regular hamburger, I'm happy with it," he said.

A handful of researchers has been working for the past six years on the technical problem of extracting stem cells from bovine muscle, culturing them in the laboratory and turning them into strips of muscle fibres that can be minced together with synthetic fat cells into an edible product.

The technical challenges have included giving the meat a pinkish colour and the right texture for cooking and eating, as well as ensuring that it feels and tastes like real meat.

Dr Post admitted to being nervous about the final result. "I am a little worried, but seeing and tasting is believing," he said.

Although some animals still have to be slaughtered to provide the bovine stem cells, scientists estimate that a million times more meat could be made from the carcass of a single cow, compared with conventional cattle rearing. As well as reducing the number of beef cattle, it would save the land, water and oil currently need to raise cattle for the meat trade, Dr Post said.

"Eventually, my vision is that you have a limited herd of donor animals that you keep in stock in the world. You basically kill animals and take all the stem cells from them, so you would still need animals for this technology."
One of the economic incentives behind the research is the increasing cost of the grain used to feed much of the world's cattle. This is helping to drive up the cost of meat.

"It comes down to the fact that animals are very inefficient at converting vegetable protein [either grass or grain] into animal protein. Yet meat demand is also going to double in the next 40 years," he said.

"Right now we are using about 70 per cent of all our agricultural capacity to grow meat through livestock. You are going to need alternatives. If we don't do anything, meat will become a luxury food and will become very expensive.

"Livestock also contribute a lot to greenhouse gas emissions, more so than our entire transport system. Livestock produces 39 per cent of the methane, 5 per cent of CO2 and 40 per cent of all the nitrous oxide. Eventually we'll have an 'eco-tax' on meat."

Growing meat in fermentation vats might be better for the environment. And it might be more acceptable to vegetarians and people concerned about the welfare of domestic livestock, Dr Post said. "There are many reasons why people are vegetarian. I've talked to the Dutch vegetarian society, which has said that probably half of its members will eat this meat if it has cost fewer animal lives and requires less intensive farming," Dr Post said. Growing artificial meat would also allow greater control over its makeup. It will be possible, for example, to alter the fat content, or the amount of polyunsaturated fats vs saturated fats, according to Dr Post.

"You can probably make meat healthier," he said. "You can probably trigger these cells to make more polyunsaturated fatty acids, just like grass-fed beef has more polyunsaturates than grain-fed beef. You could make any type of meat, you could make mixed meats. I'm pretty sure you could even make panda meat."

Dr Post declined to reveal who his backer was, except to say that he was well known but not a celebrity - and not British. "It's a very reputable source of money," he said. "He's an individual. There may be two reasons why he wants to remain anonymous: as soon as his name is associated with this technology he will draw the attention to himself and he doesn't really want to do that."

Dr Post added: "And the second reason is that he has the image of whatever he does turns into gold and he is not sure that may be the case here so he doesn't want to be associated with a potential failure."

LAB-GROWN MEAT THE CASE FOR AND AGAINST:
 

Pros

Billions of animals would be spared from suffering in factory farms and slaughterhouses Would reduce the environmental impacts of livestock production, which the UN's Food and Agriculture Organisation estimates account for 18 per cent of greenhouse-gas emissions Could reduce by 90 per cent the land- and water-use footprint of meat production, according to Oxford University research, freeing those resources for more efficient forms of food production Would provide a more sustainable way to meet demand from China and India, whose growing appetite for meat is expected to double global meat consumption by 2040 Lab-grown meat could be healthier - free of hormones, antibiotics, bacteria such as salmonella and E.coli, and engineered to contain a lower fat content Would reduce the threat of swine and avian flu outbreaks associated with factory farming

Cons

Consumers may find the notion of lab-grown meat creepy or unnatural - a "Frankenstein food" reminiscent of the Soylent Green at the heart of the 1973 sci-fi film of the same name For some vegetarians, in vitro meat will be unsatisfactory as it perpetuates "meat addiction" - rather than focusing on promoting non-meat alternatives, and changing our meat-heavy diet Although the fat content can be tinkered with, other risks of eating red meat, such as an increased threat of bowel cancer, remain It's not cruelty-free - animals will still have to be slaughtered to provide the bovine stem cells There could be unforeseen health consequences to eating lab-grown meat As a highly processed, "unnatural" foodstuff, lab-grown meat is a step in the wrong direction for "slow-food" advocates, and others who believe the problems in our food system have their origins in the distance between food production and the consumer

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Blumenthal to cook $250,000 burger?

11-01-2012 16:32 One doctor's desire to improve patient care led to the creation of BioLife Cell Bank. Renowned craniofacial surgeon, Dr. David G. Genecov, was dissatisfied with having to subject patients to multiple liposuction procedures in order for them to experience the optimal results and benefits of fat grafting (transferring fat from one location in the body to another). He and his team developed a way to remove fat and stem cells and successfully store them for recurring, future use for patients like Angela with Parry Romberg Syndrome--and now for use in cosmetic and therapeutic treatments. BioLife Cell Bank in Dallas is the first in the world to preserve fat and stem cells for future use in cosmetic and regenerative medical treatments. Fat (and the stem cells within it) are extracted through liposuction and sent to BioLife Cell Bank in a special kit. BioLife processes and cryopreserves the cells so that they are available for future use in a variety of reconstructive, aesthetic and therapeutic treatments. http://www.biolifecellbank.com

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BioLife Cell Bank - Beginnings - Video

(CNN) -

If you're concerned about the ethics of livestock production but don't want to become a vegetarian, consider this: It may be possible to grow meat in a petri dish.

Dr. Mark Post, professor of vascular physiology at the University of Maastricht in the Netherlands, is working on creating meat from bovine stem cells. And he's planning to unveil a burger created this way in October, he said Sunday at the annual meeting of the American Association for the Advancement of Science in Vancouver.

Croplands and pastures occupy about 35% of the planet's ice-free land surface, according to a 2007 study in Proceedings of the National Academy of Science.

"Meat consumption is going to double in the next 40 years or so, so we need to come up with alternatives to solve the land issue," Post said.

Post's financial backer, whose identity Post would not disclose, is providing 250,000 euros (about $330,000) toward the development of this hamburger. And the financier has the right to choose who will be the lucky person to taste this futuristic burger, Post said.

The scientists say their creations are not quite at the level of hamburger, though -- samples from cultures are currently about 3 centimeters (1.2 inches) long and weigh only half a gram. That's too small to cook. Post hasn't tasted it yet himself.

To get the samples bigger and more burger-looking, scientists may grow them on a spherical surface. Eventually they'd like to be able to create big slabs of meat, Post said.

The color is pinkish-yellowish, and Post and colleagues would like to make it look more appetizing in a natural way. Meat in typical hamburgers gets its color partly from blood. One way to make the stem-cell meat more authentic-looking is to use caffeine to coerce the cells to produce more myoglobin, a type of protein that carries iron and oxygen.

Apart from the "meat," scientists need to grow fat separately, for the juiciness and taste of the final product.

Right now the process doesn't involve harming animals -- researchers are using leftover materials from slaughterhouses. But in the future, the process could use animals that would be killed so that all of their stem cells could be harvested, he said.

You could get about 1 million times as many burgers from a single cow using these stem cell methods as you would from traditional processes, Post said.

But obviously Post's process is expensive and requires a lot of effort.

So how long will it take until the process of making stem cell burgers becomes more efficient than regular burgers?

With the resources Post and colleagues have right now, it's never going to happen, he says. With unlimited resources, it would still take 10 to 20 years.

Copyright 2012 by CNN NewSource. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Effort aims to create meat from bovine stem cells

A Panamanian-led, multidisciplinary research team has published the first description of non-expanded fat stem cells in the treatment of rheumatoid arthritis patients. "Autologous Stromal Vascular Fraction Therapy for Rheumatoid Arthritis: Rationale and Clinical Safety," which appears in the January publication of the International Archives of Medicine, followed 13 rheumatoid arthritis patients who were treated with their own fat-derived stem cells.

Dallas, TX (PRWEB) February 21, 2012

A Panamanian-led, multidisciplinary research team has published the first description of non-expanded fat stem cells in the treatment of rheumatoid arthritis patients. "Autologous Stromal Vascular Fraction Therapy for Rheumatoid Arthritis: Rationale and Clinical Safety," which appears in the January publication of the International Archives of Medicine, followed 13 rheumatoid arthritis patients who were treated with their own fat-derived stem cells.

Treating arthritis with fat-derived stem cells has become commonplace in veterinary medicine over the past five years with over 7,000 horses and dogs treated by publication contributor Vet-Stem, a San Diego-based company. The objective of the joint Panamanian-US study was to determine feasibility of translating Vet-Stem's successful animal results into human patients.

Observing no treatment associated adverse reactions after one year, the team concluded that its protocol should be studied further to determine efficacy in the treatment of rheumatoid arthritis. Their publication details the rationale for the use of fat derived stem cells in treatment of autoimmune conditions and is freely available at: http://www.intarchmed.com/content/pdf/1755-7682-5-5.pdf

“Key to advancement of any medical protocol is transparent disclosure of rationale, treatment procedures and outcomes to the research community in a peer-reviewed and IRB-compliant manner,” said Dr. Jorge Paz Rodriguez, Medical Director of the Stem Cell Institute and research team leader. “While we have previously published case studies on the use of fat stem cells in multiple sclerosis patients, and one rheumatoid arthritis patient, this is the first time that comprehensive follow-up has been completed for a larger cohort of patients,” he added.

An important distinction that separates this particular approach from those which are being explored by several international investigators is that the fat stem cells were not grown in a laboratory, affording a substantially higher level of safety and protocol practicality.

“This work signifies Panama's emergence into the burgeoning field of translational medicine,” commented Dr. Ruben Berrocal Timmons, the Panamanian Secretary of Science and publication co-author. “We are proud to have attracted and collaborated with internationally-renowned stem cell clinical researchers such as Dr. Michael Murphy and Dr. Keith March from the Indiana University School of Medicine Center for Vascular Biology and Medicine, Dr. Boris Minev from the University of California, San Diego Moores Cancer Center, Dr. Chien Shing Chen from Loma Linda University Behavioral Medicine Center and Dr. Bob Harman from Vet-Stem. By leveraging their vast, collective clinical experience with Panamanian scientific infrastructure and know-how, we are striving to develop effective, internationally recognized stem cell procedures that will be accepted the world over.”

The treatment procedure involves a mini-liposuction, collection of the fat's cellular component, processing to obtain a population of cells that includes stem cells, freezing the cells in preparation for quality control, and subsequent re-administration of the cells into patients.

The Panamanian-US group has previously shown that there is a specific type of T cell, called the T regulatory cell, associated with fat stem cells, which is capable of suppressing pathological immunity. Their current theory, which is described in detail in the publication: http://www.ncbi.nlm.nih.gov/pubmed/20537320, is that the T regulatory component of the fat is capable of slowing down or suppressing the “autoimmune” reaction, while the stem cell component causes formation of new tissue to replace the damaged joints.

About the Stem Cell Institute

Founded in 2006 on the principles of providing unbiased, scientifically-sound treatment options, the Stem Cell Institute has matured into the world’s leading adult stem cell therapy and research center. In close collaboration with universities and physicians world-wide, the institute’s doctors treat carefully selected patients with spinal cord injury, osteoarthritis, heart disease, multiple sclerosis, rheumatoid arthritis and other autoimmune diseases. Doctors at The Stem Cell Institute have treated over 1000 patients to-date.

For more information on stem cell therapy:

Stem Cell Institute Web Site: http://www.cellmedicine.com

Facebook: http://www.facebook.com/stemcellinstitute

Blogger: http://www.adult-stem-cell-therapy.blogspot.com

Stem Cell Institute

Via Israel & Calle 66

Pacifica Plaza Office #2A

San Francisco, Panama

Republic of Panama

Phone: +1 800 980-STEM (7836) (USA Toll-free) +1 954 636-3390 (from outside USA)

Fax: +1 866 775-3951 (USA Toll-free) +1 775 887-1194 (from outside USA)

###

Jay Lenner
jdlenner@cellmedicine.com
1-800-980-7836
Email Information

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Panamanian-US Scientific Research Supports Using Fat Stem Cells to Treat Rheumatoid Arthritis

Pet stem cells frozen and banked for future

ORLANDO, Fla. -

Eight Central Florida veterinary clinics are offering up a new procedure that could save or greatly improve a pet's life.

MediVet America has set up a holding center at the company's Nicholasville, Ken., lab to freeze and store pet stem cells for future use.  Clinical studies have shown the cells can be viable for decades.

The procedure extracts stem cells from the animal's own fat tissue. The cells are then treated and used for aging dogs and cats struggling with arthritis or degenerative disease for several years, with good results.

By "cryobanking," the healthy cells, they will be ready if needed in the future.

"Banking stem cells is like having an extra insurance policy for your pet," explained Jeremy Delk, CEO of MediVet America.

Dr. Daniel Evers of ValuVet is taking part in a pet stem cell project in Central Florida to determine if the stem cells are actually causing cartilage regeneration.

Twelve pets will be selected for the study, which will include two separate MRI scans to determine how effective the stem cell treatments are for pets struggling with joint issues.

[SHARE YOUR PHOTOS: Picture-perfect pets]

Normally, the initial cost is $420, with a $150 annual storage fee. Owners whose pets are selected will get a discount on the stem cell procedure. Pet owners interested in the procedure can contact Erica Kent at erica@medivet-america.com or call 386-748-4251.

Copyright 2012 by ClickOrlando.com. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Pet stem cells frozen and banked for future

Pet stem cells frozen and banked for future

ORLANDO, Fla. -

Eight Central Florida veterinary clinics are offering up a new procedure that could save or greatly improve a pet's life.

MediVet America has set up a holding center at the company's Nicholasville, Ken., lab to freeze and store pet stem cells for future use.  Clinical studies have shown the cells can be viable for decades.

The procedure extracts stem cells from the animal's own fat tissue. The cells are then treated and used for aging dogs and cats struggling with arthritis or degenerative disease for several years, with good results.

By "cryobanking," the healthy cells, they will be ready if needed in the future.

"Banking stem cells is like having an extra insurance policy for your pet," explained Jeremy Delk, CEO of MediVet America.

Dr. Daniel Evers of ValuVet is taking part in a pet stem cell project in Central Florida to determine if the stem cells are actually causing cartilage regeneration.

Twelve pets will be selected for the study, which will include two separate MRI scans to determine how effective the stem cell treatments are for pets struggling with joint issues.

[SHARE YOUR PHOTOS: Picture-perfect pets]

Normally, the initial cost is $420, with a $150 annual storage fee. Owners whose pets are selected will get a discount on the stem cell procedure. Pet owners interested in the procedure can contact Erica Kent at erica@medivet-america.com or call 386-748-4251.

Copyright 2012 by ClickOrlando.com. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Pet stem cells frozen, banked for future

05-01-2012 13:13 BioLife Cell Bank co-founder and medical director, Dr. David G. Genecov discusses how BioLife fat and stem cell banking originated. BioLife Cell Bank in Dallas is the first in the world to preserve fat and stem cells for future use in cosmetic and regenerative medical treatments. Fat (and the stem cells within it) are extracted through liposuction and sent to BioLife Cell Bank in a special kit. BioLife processes and cryopreserves the cells so that they are available for future use in a variety of reconstructive, aesthetic and therapeutic treatments. http://www.biolifecellbank.com

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Dr. Genecov Shares How BioLife Cell Bank Was Born - Video

20-01-2012 10:50 University of Pittsburgh announces a new finding from their stem cell research. The aging process is stalled using young stem cells from the fat of young mice. Published in Nature Communications and reported on Fox TV, Dr. Niedernhofer and Dr. Huard expressed their excitement on the possibilities of this new research.

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New Report from University of Pittsburgh Regarding Stem Cells and Anti Aging - Video

Would you like fries with that? British celebrity chef Heston Blumenthal could be flipping test-tube burgers.

LURKING in a petri dish in a laboratory in the Netherlands is an unlikely contender for the future of food. The yellow-pink sliver is state-of-the-art in lab-grown meat and a milestone on the path to the world's first burger made from stem cells.

Dr Mark Post, the head of physiology at Maastricht University, plans to unveil a complete burger - produced at a cost of more than $290,000 - this October.

He hopes Heston Blumenthal, the chef and owner of the three Michelin-starred Fat Duck restaurant in Berkshire, southern England, will cook the offering for a celebrity taster.

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A new meaning to instant meals ... food in a test-tube.

The project, funded by a wealthy, anonymous, individual, aims to slash the number of cattle farmed for food and reduce one of the major contributors to greenhouse gas emissions.

''Meat demand is going to double in the next 40 years and right now we are using 70 per cent of all our agricultural capacity to grow meat through livestock,'' Dr Post said.

''You can easily calculate that we need alternatives. If you don't do anything meat will become a luxury food and be very, very expensive.''

Livestock contribute to global warming through unchecked releases of methane, a gas 20 times more potent than carbon dioxide.

At the American Association for the Advancement of Science meeting in Vancouver, Dr Post said the burger would be a ''proof of concept'' to demonstrate that ''with in-vitro methods, out of stem cells we can make a product that looks like and feels and hopefully tastes like meat.''

Dr Post is focusing on making beef burgers from stem cells because cows are among the least efficient animals at converting the food they eat into food for humans.

Dr Post and his team have so far grown thin sheets of cow muscle measuring 3 centimetres long, 1.5 centimetres wide and half a millimetre thick. To make a burger will take 3000 pieces of muscle and a few hundred pieces of fatty tissue, that will be minced together and pressed into a patty.

Each piece of muscle is made by extracting stem cells from cow muscle tissue and growing them in containers. The cells are grown in a culture medium containing foetal calf serum, which contains scores of nutrients the cells need to grow.

Guardian News & Media

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At $290,000 test-tube burger is a taste of what's to come

Prototype burger will cost ?220,000 to produce

By Fiona Macrae Science Correspondent

Last updated at 10:16 PM on 19th February 2012

The world’s first test-tube burger will be ready to eat within months.

It will look, feel and, it is hoped, taste, like a regular quarter-pounder, its creator Mark Post told the world’s premier science conference.

He plans to unveil the hamburger in October - and hopes celebrity chef Heston Blumenthal will cook it, although he has yet to approach him.

Tasty: A small sample of the lab-grown 'meat' which Dutch stem cell scientist Dr Mark Post believes everyone will want to eat

The ‘ethical meat’ will would be kinder to the environment than the real thing, reduce animal suffering and help feed the world’s burgeoning population.

But it will be far from cheap with the prototype burger costing ?220,000 to produce.

Professor Post says that ‘everyone’ will want to eat the burgers, which, despite their vast initial cost could eventually be priced to match that of real meat.

However, it remains to be seen whether a public that likes to think of its chops, steaks and sausages as having their roots in nature will take to meat made in test-tubes.

The Maastricht Univeristy professor has spent the last six years trying to turn stem cells - ‘master cells’ with the power to turn into all other cell types - into meat.

Real thing: But the new meat  could be an ethical alternative to beef

He first attempts involved mouse burgers. He then tried to grow pork in a dish, producing strips with the rubbery texture of squid or scallops, before settling on beef.

A four-step technique is used to turn stem cells from animal flesh into a burger.

First, the stem cells are stripped from the cow’s muscle.

Next, they are incubated in a nutrient broth until they multiply many times over, creating a sticky tissue with the consistency of an undercooked egg.

This ‘wasted muscle’ is then bulked up through the laboratory equivalent of exercise - it is anchored to Velcro and stretched.

Finally, 3,000 strips of the lab-grown meat are minced, and, along with 200 pieces of lab-grown animal fat, formed into a burger.

The process is still lengthy, as well as expensive, but optimised, it could take just six weeks from stem cell to supermarket shelf.

Yesterday, Professor Post told the American Association for the Advancement of Science’s annual conference in Vancouver that he has so far made a strip of beef measuring 3cm by 1.5cm by 0.5cm.

This beef is ‘pinkish to yellow’ in colour - but he is confident of having a full-sized and properly coloured burger by the autumn.

The professor, who is funded by an anonymous but highly-successful benefactor, said: ‘It’s not quite ready, it’s going to be presented in October.

‘We are going to provide a proof of concept, showing that out of stem cells you can produce a product that looks like and feels like and hopefully tastes like meat.

‘Seeing and tasting is believing.’ Sausages and other processed meat products could swiftly follow, although pork chops and sirloin steaks will be much more problematic.

Other possibilities include synthetic versions of the meat from are animals such as pandas and tigers.

Meats could also be made extra-healthy by boosting their content of ‘good’ fats.

Far fewer animals would have to be kept to satisfy the appetite for meat.

The stem cell’s extraordinary ability to grow and multiply means that a cells taken from a single cow could produce a million times more burgers than if the animal was slaughtered for meat.

Choice: Professor Post hopes experimental chef Heston Blumenthal will have a go at cooking his new invention

Researchers say they realise that many will find the idea of eating lab-grown meat unnatural - but point out that the livestock eaten at the moment is often kept in cramped conditions and dosed with chemicals or antibiotics.

However, the fact that the source material comes from animals who will likely have slaughtered means that not all vegetarians will be happy with the product.

The fledgling technology was highlighted in discussion paper about current and future demands on livestock production published recently by the Royal Society, Britain’s most prestigious scientific body.

The paper’s author, Professor Philip Thornton, of the International Livestock Research Institute in Edinburgh, wrote: ‘This is one example of something that could happen in the future that could have a very big impact on agriculture and livestock production.

‘There are some advantages to the idea. For example, you could reduce the number of live animals substantially and that would reduce greenhouse gas production.

‘There might be human health benefits because the health and safety issues associated with meat could be much better controlled.

‘But are people going to eat it? People’s tastes have changed a lot over the years and eventually this may be something that is widely taken up.’

Cautioning about the economic impact on farmers, the professor said: ‘If you are talking about large-scale reductions in numbers of livestock, there are large-scale implications and we’d have to look very carefully to see if the benefits would outweigh some of the problems that might arise.’

It will be at least ten years before the artificial meat is produced on an industrial scale and has satisfied the safety testing necessary for it be placed on supermarket shelves.

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Test tube burgers could hit kitchens this year after scientists create meat with taste of quarter-pounder

JANIE McCAULEY PHOENIX— The Associated Press Published Saturday, Feb. 18, 2012 5:50PM EST

Bartolo Colon had no idea how he would bounce back from a stem-cell procedure that saved his career.

Two years ago, fat and bone marrow stem cells were collected from Colon and injected into his troublesome right elbow and shoulder in an innovative and unproven technique. Colon had no idea how it would turn out, but he responded and spent 2011 with the Yankees.

“I was a little bit nervous,” he said in Spanish. “I didn't know what the result would be.”

Now, Colon is getting a new start back in the AL West with the Oakland Athletics, whose pitchers and catchers reported to spring training Saturday.

The fact he is pitching another season with a fresh arm? “Incredible,” he says.

Colon received a handshake and hug from new teammate and outfielder Jonny Gomes after completing his physical. The pitcher proclaimed himself healthy and appreciative of another shot at age 38.

“He continues at his age to be a power pitcher,” manager Bob Melvin said following a four-hour meeting of the A's brass. “He's a cagey veteran, he knows what he has to do each and every year to make some adjustments to keep on top of his game like he has. ... We felt he was the right fit here based on the guys we had a chance to get.”

The 2005 AL Cy Young Award winner went 8-10 with a 4.00 ERA in 29 appearances and 26 starts in his 14th big league season after missing all of 2010.

“My health is good,” he said. “No problems. I'm ready to play for Oakland.”

Colon signed a $2 million, one-year contract last month to join a rotation that lost two top pitchers this offseason. All-Star left-hander Gio Gonzalez got traded to the Washington Nationals, while Trevor Cahill was dealt to the Arizona Diamondbacks. Closer Andrew Bailey is also gone, sent to Boston in late December.

Colon said he will embrace being a veteran presence for the young A's, whose roster still could change over the next week. The A's are considering signing slugger Manny Ramirez, who would have to sit out the first 50 games for his second violation of baseball's drug policy.

“Definitely possibilities,” Melvin said. “I'm not certain that we're done on what our roster's going to look like. I think we've shown this offseason that we're not afraid to make some moves.”

Gomes, who lives in Arizona during the offseason, showed up early to get going — and make a few more introductions for those he didn't meet at FanFest last month.

“This is the time of year you want to get out of the batting cage and get out of the weight room and put some cleats on,” Gomes said. “You know your feet are going to hurt and your calves are going to cramp.”

Everybody knows there's plenty to get done in an abbreviated spring. Oakland opens the season with two games in Japan next month against the Mariners, who started at spring training a week ago. The A's opted to wait.

Melvin said he would typically try to get position players 60 to 65 at-bats during Cactus League play before the season starts, but “we're not going to try to cram that into 21 games.”

The emphasis will be to get as much work done each day while minimizing players' time standing around between drills.

“Oh, we're rusty,” reliever Jerry Blevins halfway joked while signing autographs for a couple of diehard fans in the bleachers after playing Frisbee at Phoenix Municipal Stadium with 6-foot-6 starting candidate Tyson Ross.

Dallas Braden is upbeat entering the spring. Braden, who threw a perfect game on May 9, 2010, against Tampa Bay, is encouraged by his progress following surgery May 17 to a repair a torn capsule in his left shoulder.

While Braden is ahead of schedule in his recovery, his best guess is that he will be ready to return in mid-April or shortly thereafter. Melvin said it could be early May for Braden, who will be treated cautiously.

Braden threw his fourth bullpen of the winter Thursday and is slated for another on Monday. He praised the training staff for being “lights out.”

“Just being able to throw a baseball pain-free has been tremendous,” Braden said. “The last two years I had been throwing in pain, not with pain but in pain. That's tough to do. I take my bullpens very seriously. To be getting back to a position where I can learn again from my work, that's Christmas for me. Everything points to positive.”

Braden has some other business to attend to this spring. He wears No. 51, and that has been the jersey number for new outfielder Yoenis Cespedes, the Cuban defector who this past week agreed to terms on a $36 million, four-year contract.

“For $35.5 million he can have No. 51,” Braden said with a chuckle. “I'm going to put that on his locker. I don't know if we go much lower than that. Do you really want No. 51?”

Perhaps Colon will be up for a swap as he is No. 52. He has surprised even himself considering he's still pitching after all the years of injury problems.

“It is a surprise for me,” he said. “I didn't know I was going to come back and pitch.”

Melvin is confident in Colon, saying, “If he's pitching at the level he is at this age he's doing something right.”

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Bartolo Colon eager to pitch for A's

Public release date: 16-Feb-2012
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Contact: Anne Craig
anne.craig@queensu.ca
613-533-2877
Queen's University

A new process for transforming discarded human fat into a soft-tissue substitute for use in reconstructive surgery is laying the groundwork for creating an Ontario-based regenerative medicine initiative focused on developing products for reconstructive and cosmetic surgery.

"Human fat is an abundant and accessible source of stem cells and proteins that can be used in tissue engineering," says Lauren Flynn, Queen's University chemical engineer who pioneered the process. "We use tissues that are normally discarded during surgery, to develop non-immunogenic structures that have shown great promise in promoting natural soft tissue regeneration."

Dr. Flynn's technology can be used in repairing or replacing damaged or missing soft tissue caused by traumatic injury, burns, congenital defects or tumour resections such as in breast cancer surgery. The process removes the cells and other components from fat leaving behind a component that, when implanted in the body, can stimulate the regeneration of healthy soft tissue.

Further development of the technology is possible through $192,500 in funding from MaRS Innovation Medical Sciences Competitive Proof of Principle. The program is part of the Ontario Centres of Excellence Institutional Proof of Principle program.

###

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Queen's soft tissue replacement technology gets a funding boost

Just before 10 a.m. Tuesday, Jake — a hobbling, 12-year-old yellow Labrador retriever — went into surgery at the Stanley Veterinary Clinic in Overland Park with crippling arthritis, no longer able to run without pain or even walk down stairs.

He had already been on months of medications that seemed to turn the normally happy dog sad. And hip and joint replacements costing tens of thousands of dollars were not feasible, said owners Mike and Elizabeth LeBlanc of Leawood.Still, their 8-year-old daughter, Mia, had just one request at Christmas. “All I want is for Jake to feel better,” she wrote.So, on Tuesday morning, Jake became one of the first canines in the Kansas City area to undergo a somewhat new and controversial procedure in which stem cells were harvested from the fat of his own body and then injected into his joints. The expectation is that within a few weeks the cells will regenerate missing cartilage and turn his arthritic joints healthy again.“It’s amazing,” said veterinarian Les E. Pelfrey, who conducted the procedure. “A few weeks later, these guys are running up and down.”The stem-cell procedure, which has gained notice in recent years with anecdotal stories of success on YouTube and cable television, remains controversial not only for its quick adoption in veterinary clinics nationwide, but also because some researchers say it remains scientifically unproven and expensive, at $1,800 or more per treatment.“Let me tell you one thing,” said James L. Cook, a professor of orthopedics at the University of Missouri’s College of Veterinary Medicine. “I don’t want to write off stem cells. Stem cells may hold the key for truly restorative medicine.”In horses, stems cells have been shown to help rejuvenate damaged tendons and other problems. They are being tested for cardiac problems.“But in the joints for dogs with arthritis? No way,” Cook said. “I would never recommend anyone get this done.”Stem cells essentially are the equivalent of young and impressionable cells whose genetic gears have yet to determine their fate. Because they are so young, they theoretically can turn into any kind of cell, from cartilage to neurons. In humans, stem cells have long been held out as possible therapy for diseases such as Parkinson’s.The problem, Cook said, is that although a few studies have shown that the injection of stem cells into arthritic canine joints does reduce pain, compared with “control” dogs not injected with stems cells, no studies have convincingly shown that stems cells are any better at helping dogs than the current, and less expensive, standard of care. That typically involves a combination of weight loss, pain medications and, when necessary, injections of hyaluronic acid, a slippery substance that often goes missing in arthritis. Those injections, given a couple of times a year, cost less than $100 each.Moreover, even if the stem cells work, no one knows at this point how long the improvement will persist, although some vets have noted benefits lasting a year or more.“We know for sure that it (stem cell injections) does have some palliative effects. It can make symptoms better,” Cook said. “And we do know for sure that it does not regenerate cartilage in arthritic joints. The palliative effects are not as good, or no better, than hyaluronic acid injections.”That is far from the case being made by companies now promoting stem-cell therapy in dogs, or owners who believe in it.A number of stem-cell companies have emerged in recent years. Chief among them are Vet-Stem, based in Poway, Calif., and MediVet America, a division of MediVet, based in Sydney, Australia, which notes that it is currently conducting studies on canines, stem cells and cartilage regeneration.Both use largely similar technologies and methods. At the vet’s office, the dog undergoes a quick procedure in which a bolus of fat about the size of a golf ball is taken from above the shoulder.The fat is processed and treated with chemicals to extract millions of stem cells. Some of those cells are then injected into a dog’s damaged joints; the rest enter the body through an intravenous line into the bloodstream.One prime difference between the Vet-Stem and MediVet systems is that Vet-Stem costs about $3,000 or more.Vet-Stem requires the veterinarian to ship the fat sample to California, where it is processed and sent back for injection. Several dogs in the Kansas City area have been injected with stem cells from Vet-Stem.The MediVet system costs pet owners about $1,800. It provides veterinarians with a kit to process the stem cells in their own offices over about four hours. Dogs are injected with stems cells on the same day the fat is removed. The pet typically goes home the next day.In Topeka, the University Bird and Small Animal Clinic has used the MediVet kit and system with what it says are positive results on about 40 dogs since November 2010. A veterinarian there, Larry Snyder, helped train Pelfrey in Overland Park.Snyder came to the clinic two weeks ago to perform the procedure on another hobbled yellow Labrador retriever, Milo, owned by dentist Jon Finley and his wife, Sharon, in Leawood.“Dr. Pelfrey and Mrs. Finley didn’t tell me how much this procedure was going to cost,” Jon Finley said, “and I’d rather you not tell me. No matter what, he’s walking better, standing upright, feeling better. I can’t help but think he’s going to get better and better.”Jake’s owner said that, whatever the outcome, she knows that the procedure is not a cure.“I’m hoping this gives him a better quality of life,” Elizabeth LeBlanc said. “I got him when he was just 6 weeks old. He was such a blessing. It will be worth it, even if I can give him one more great summer.”

To reach Eric Adler, call 816-234-4431 or send email to eadler@kcstar.com.

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First local dogs receive ‘amazing’ stem-cell therapy

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Posted February 14, 2012

SUNRISE, Fla., -- Bioheart, Inc. (BHRT.OB) announced today that it has acquired the worldwide exclusive rights to Ageless Regenerative Institute's adipose (fat) derived therapeutic cell technology for use in the cardiac field.

"The Ageless adipose stem cell technology will allow us to broaden our portfolio of product candidates for cardiac patients," said Mike Tomas, President and CEO of Bioheart. "We have successfully treated patients in Mexico and now we are ready to expand into the US."

Adipose tissue is readily available and has been shown to be rich in microvascular, myogenic and angiogenic cells. Bioheart has recently applied to the FDA to begin trials using adipose derived stem cells or LipiCellTM in patients with chronic ischemic cardiomyopathy. Transplantation of LipiCellTM will be accomplished through endocardial implantations with the MyoStarTM Injection Catheter under the guidance of the NOGA® cardiac navigation system by Biosense Webster, Inc. - A Johnson & Johnson Company.

Under the terms of the agreement, Bioheart will have a worldwide exclusive license to all of Ageless technology for use in the heart attack and heart failure markets. The agreement provides for upfront and milestone equity payments to Ageless.

Ageless' President and Chief Executive Officer, Dr. Sharon McQuillan, MD added, "We are excited about this collaboration with Bioheart, a leader in developing cell therapies for cardiovascular disease. Together with Bioheart, we can help to revolutionize cardiovascular medicine and improve the current standard of care for these patients."

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.

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

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

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Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute's Adipose Cell Technology

Stem cells are proving themselves beneficial once again after scientists used the controversial building blocks to resurrect dead, scarred heart muscle damaged by recent heart attack.

Results from a Cedars-Sinai Heart Institute clinical trial show that treating heart attack patients with an infusion of their own heart-derived cells helps damaged hearts re-grow healthy heart muscle.

Reporting in The Lancet medical journal, the researchers said this is the clearest evidence yet that broken hearts can heal. All that is needed is a little help from one’s own heart stem cells.

“We have been trying as doctors for centuries to find a treatment that actually reverses heart injury,” Eduardo Marban, MD, PhD, and lead author of the study, told WebMD. “That is what we seem to have been able to achieve in this small number of patients. If so, this could change the nature of medicine. We could go to the root of disease and cure it instead of just work around it.”

Marban invented the “cardiosphere” culture technique used to create the stem cells and founded the company developing the treatment.

“These findings suggest that this therapeutic approach is feasible and has the potential to provide a treatment strategy for cardiac regeneration after [heart attack],” wrote University of Hong Kong researchers Chung-Wah Siu and Hung-Fat Tse in an accompanying editorial of Marban’s paper.

The British Heart Foundation told James Gallagher of BBC News that this could “be great news for heart attack patients” in the future.

A heart attack occurs when the heart is starved of oxygen, such as when a clot is blocking the blood flow to the organ. As the heart heals, the dead muscle is replaced by scar tissue, which does not beat like heart muscle. This in turn reduces the hearts ability to pump blood around the body.

Doctors have long been searching for ways to regenerate damaged heart muscle, and now, it seems heart stem cells are the answer. And the Cedars-Sinai trial was designed to test the safety of using stem cells taken from a heart attack patient’s own heart.

The researchers found that one year after receiving the treatment, scar size was reduced from 24 percent to 12 percent of the heart in patients treated with heart stem cells. Patients in the control group, who did not receive stem cells, did not experience a reduction in their heart attack scar tissues.

“While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and re-grow lost heart muscle,” Marban said in a statement. “This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it. The effects are substantial, and surprisingly larger in humans than they were in animal tests.”

“These results signal an approaching paradigm shift in the care of heart attack patients,” said Shlomo Melmed, MD, dean of the Cedars-Sinai medical faculty and the Helene A. and Philip E. Hixon Chair in Investigative Medicine. “In the past, all we could do was to try to minimize heart damage by promptly opening up an occluded artery. Now, this study shows there is a regenerative therapy that may actually reverse the damage caused by a heart attack.”

Marban cautioned that stem cells do not do what people generally think they do. The general idea has been that stem cells multiply over and over again, and, in time, they turn themselves and their daughter cells into new, working heart muscle.

But Marban said the stem cells are actually doing something more amazing.

“For reasons we didn’t initially know, they stimulate the heart to fix itself,” he told Daniel J. DeNoon of WebMD. “The repair is from the heart itself and not from the cells we give them.”

Exactly how the stem cells invigorate the heart to do this was a matter of “feverish research” in the lab.

The CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction (CADUCEUS) clinical trial was part of a Phase I study approved by the US Food and Drug Administration (FDA) and supported by the National Heart, Lung, and Blood Institute.

Marban used 25 volunteer patients who were of an average age of 53 and had recently suffered a heart attack that left them with damaged heart muscle. Each patient underwent extensive imaging scans so doctors could pinpoint the exact location and severity of the scars. Patients were treated at Cedars-Sinai in LA and at Johns Hopkins Hospital in Baltimore.

Eight of the 25 patients served as a control group, receiving conventional medical treatment. The other 17 patients who were randomized to receive the stem cell treatments underwent a minimally invasive biopsy, under local anesthesia. Using a catheter inserted through a vein in the neck, doctors removed a small sample of heart tissue, about half the size of a raisin. The heart tissue was then taken to the lab at Cedars-Sinai and cultured and multiplied the cells using specially developed tools.

The doctors then took the multiplied heart-derived cells — roughly 12 million to 25 million of them per patient — and reintroduced them into the patient’s coronary arteries during another minimally invasive catheter procedure.

The process used in the trial was developed earlier by Marban when he was on the faculty at Johns Hopkins. Johns Hopkins has filed for a patent on the intellectual property and has licensed it to a company in which Marban has a financial interest. However, no funds from that company were used to support the clinical study. All funding was derived from the National Institutes of Health and Cedars-Sinai Medical Center.

This study followed another in which doctors reported using cells taken from the heart to heal the heart. That trial reported in November 2011 that cells could be used to heal the hearts of heart failure patients who were having heart bypass surgery.

And another trial is about to get underway in Europe, which will be the largest ever for stem cell therapy in heart attack patients.

The BAMI trial will inject 3,000 heart attack patients with stem cells taken from their bone marrow within five days of the heart attack.

Marban said despite the heart’s ability to re-grow heart muscle with the help of heart stem cells, they found no increase in a significant measure of the heart’s ability to pump — the left ventricle ejection fraction: the percentage of blood pumped out of the left ventricle.

Professor Anthony Mathur, a coordinating researcher for the upcoming BAMI trial, said that even if the Marban trial found an increase in ejection fraction then it would be the source of much debate. As it was a proof-of-concept study, with a small group of patients, “proving it is safe and feasible is all you can ask.”

“The findings would be very interesting, but obviously they need further clarification and evidence,” he told BBC News.

“It’s the first time these scientists’ potentially exciting work has been carried out in humans, and the results are very encouraging,” Professor Jeremy Pearson, associate medical director at the British Heart Foundation, told BBC News.

“These cells have been proven to form heart muscle in a petri dish but now they seem to be doing the same thing when injected back into the heart as part of an apparently safe procedure,” he added. “It’s early days, and this research will certainly need following up, but it could be great news for heart attack patients who face the debilitating symptoms of heart failure.”

—

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Stem Cells Regrow Healthy Heart Muscle In Heart Attack Patients