Stem cell, heart heath study

HOUSTON -

Doctors from the Texas Heart Institute at St. Luke's Episcopal Hospital have found that patients with heart failure may be able to repair the damaged areas of the heart with stem cells from the patient's own bone marrow.

Doctors presented the findings at the American College of Cardiologys 61st Annual Scientific Session Saturday.

The results are from a multi-center clinical study that measured the possible benefits of using a patients own bone marrow cells to repair damaged areas of the heart suffering from severe heart failure, a condition that affects millions of Americans.

The study, which was the largest such investigation to date, found that the hearts of the patients receiving bone marrow derived stem cells showed a small but significant increase in the ability to pump oxygenated blood from the left ventricle, the hearts main pumping chamber, to the body.

The expectation is that the study will pave the way for potential new treatment options and will be important to designing and evaluating future clinical trials.

This is exactly the kind of information we need to move forward with the clinical use of stem cell therapy, said Emerson Perin, MD, PhD, Director of Clinical Research for Cardiovascular Medicine at THI, and one of the studys lead investigators.

The bone-marrow derived stem cells are helpful to the injured heart when they are themselves biologically active, added Dr. James T. Willerson, the studys principal investigator and President and Medical Director of THI.

This study moves us one step closer to being able to help patients with severe heart failure who have no other alternatives.

The study was conducted by the Cardiovascular Cell Therapy Research Network, the national consortium to conduct such research funded by the National Institutes of Healths National Heart, Lung, and Blood Institute.

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Stem cell, heart heath study

Bone Marrow Stem Cell Therapy Trial – Clues, But No Answers

(RTTNews.com) - An important clinical trial, which evaluated the use of autologous bone-marrow-cell therapy in patients with chronic ischemic heart failure, has failed to meet the prespecified end points of improvement in most measures of heart function, according to the results presented at the American College of Cardiology 2012 Scientific Sessions.

The trial dubbed, FOCUS - a phase II study, is the largest study to date to investigate if a patient's own bone marrow cells improved myocardial perfusion, reduced left ventricular end-systolic volume or enhanced maximal oxygen consumption in patients with coronary artery disease or LV dysfunction, and limiting heart failure or angina. The FOCUS trial was undertaken by the National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network.

Ninety two patients with chronic ischemic heart disease , having a left ventricular ejection fraction of 45% or less, a perfusion defect by single-photon emission tomography, or SPECT, who were no longer candidates for revascularization, were enrolled in the trial. Sixty one patients in the study were administered bone marrow cells through transendocardial injections while thirty one patients were administered placebo.

An assessment of primary endpoints at 6 months has revealed that there is no statistically significant difference between the treatment group and placebo arm in left ventricular end-systolic volume assessed by echocardiography, maximal oxygen consumption, and reversibility on SPECT. The secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion, and clinical improvement, also has not exhibited any difference between the two arms.

However, according to the study authors, exploratory analyses have revealed that left ventricular ejection fraction improved in the treatment group compared with the placebo group by 2.7%.

The authors, led by Emerson Perin, concluded that the findings provide evidence for further studies to determine the relationship between the composition and function of bone marrow product and clinical end points. Understanding these relationships will improve the design and interpretation of future studies of cardiac cell therapy, the authors noted.

The results were published online March 24 in the Journal of the American Medical Association.

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Bone Marrow Stem Cell Therapy Trial - Clues, But No Answers

Cell therapy using patient's own bone marrow may present option for heart disease

Public release date: 24-Mar-2012 [ | E-mail | Share ]

Contact: Kristin Wincek kwincek@mhif.org 612-863-0249 Minneapolis Heart Institute Foundation

CHICAGO Cell therapy may present an option for patients with ischemic heart disease to use their own bone marrow cells to repair the damaged areas of their hearts, and may pave the way for future treatment options, according to the FOCUS trial, which will be presented as a late-breaking clinical trial March 24 at the 61st annual American College of Cardiology (ACC) scientific session.

This is the largest study to date to look at stem cell therapy, using a patient's own stem cells, to repair damaged areas of the heart in patients with chronic ischemic heart disease and left ventricular dysfunction. Researchers found that left ventricular ejection fraction (the percentage of blood leaving the heart's main pumping chamber) increased by a small but significant amount (2.7 percent) in patients who received stem cell therapy. The study also revealed that the improvement in ejection fraction correlated with the number of progenitor cells (CD34+ and CD133+) in the bone marrow; and this information will help in evaluating and designing future therapies and trials.

"FOCUS is an incredibly important trial, as it has informed the cell therapy community how to better treat this high-risk patient population, and allows us to enter into an exciting, next generation of stem cell therapy armed with more data," said study investigator Timothy D. Henry, MD, an interventional cardiologist at the Minneapolis Heart Institute (MHI) at Abbott Northwestern Hospital in Minneapolis and director of research with the Minneapolis Heart Institute Foundation.

This multicenter study was conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), which is supported through a research grant from the National Institutes of Health's National, Heart, Lung and Blood Institute (NHLBI), with the goal to evaluate novel stem cell-based treatment strategies for individuals with cardiovascular disease.

FOCUS will be presented at ACC.12 by its lead investigator Emerson C. Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute, one of the five sites in the CCTRN. The Minneapolis Heart Institute is another site of the five in the network, and a large number of CCTRN patients were enrolled in Minnesota.

For this study, which took place between April 2009 and April 2011, the five sites randomly selected 92 patients to receive stem cell treatment or placebo. The symptomatic patients, with an average age 63, all had chronic ischemic heart disease and an ejection fraction of less than 45 percent (baseline 34 percent) along with heart failure and/or angina and were no longer candidates for revascularization. "These patients had no other options, as medical management failed to improve their symptoms," explained the study's co-investigator Jay Traverse, MD, an interventionalist cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital and physician researcher with the Minneapolis Heart Institute Foundation.

Bone marrow was aspirated from the patients and processed to obtain just the mononuclear fraction of the marrow. In patients randomly selected to receive stem cell therapy, physicians inserted a catheter into the heart's left ventricle to inject 100 million stem cells in more than 15 sites that showed damage on the electromechanical mapping image of the heart.

"Studies such as these are able to be completed much faster because of the team approach of the network" said Sonia I. Skarlatos, PhD, NHBLI's deputy director of the division of cardiovascular sciences and program director of CCTRN.

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Cell therapy using patient's own bone marrow may present option for heart disease

Chevy Hockenberry, Mercersburg, gets stem cell transplant at Hershey

A local toddler with a very rare disease has begun a long recovery in Penn State Hershey Childrens Hospital after chemotherapy and a stem cell transplant.

Chevy Hockenberry, the 23-month-old son of Lance Hockenberry and Melissa Johnson of Mercersburg, suffers from Hurlers syndrome, a rare inherited genetic disorder that if left untreated, causes death within five years.

People with Hurlers syndrome do not produce lysosomal alpha-L-iduronidase, an enzyme that helps break down long chains of sugar molecules. The long sugar chains build up in the body, damage internal organs and eventually lead to death.

The transplant

Chevy was diagnosed with Hurlers in January, but his symptoms started showing up long before that.

He was always sick, Johnson said by phone from Hershey. Chevy was always in and out of the hospital and had developed pneumonia and mild scoliosis.

Once he was diagnosed, the only treatment option for was a stem cell transplant.

Its not curable, Johnson said. But the stem cell transplant stops the progression.

The stem cells came from donated umbilical cords and Chevys parents because they are both carriers of Hurlers.

Chevy had multiple weeks of enzymes infusion followed by nine days of chemotherapy before the stem cell transplant.

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Chevy Hockenberry, Mercersburg, gets stem cell transplant at Hershey

Stem cell treatment could repair heart damage

CHICAGO - Patients with advanced heart disease who received an experimental stem cell therapy showed slightly improved heart function, researchers said at a major U.S. cardiology conference on Saturday.

The clinical trial involved 92 patients, with an average age of 63, who were picked at random to get either a placebo or a series of injections of their own stem cells, taken from their bone marrow, into damaged areas of their hearts.

The patients all had chronic heart disease, along with either heart failure or angina, and their left ventricles were pumping at less than 45 per cent of capacity.

All the participants in the study were ineligible for revascularization surgery, such as coronary bypass to restore blood flow, because their heart disease was so advanced.

Those who received the stem cell therapy saw a small but significant boost in the heart's ability to pump blood, measuring the increase from the heart's main pumping chamber at 2.7 per cent more than placebo patients.

Study authors described the trial as the largest to date to examine stem cell therapy as a route to repairing the heart in patients with chronic ischemic heart disease and left ventricular dysfunction.

"This is the kind of information we need in order to move forward with the clinical use of stem cell therapy," said lead investigator Emerson Perin, director of clinical research for cardiovascular medicine at the Texas Heart Institute.

Perin's research, which was conducted between 2009 and 2011 across five U.S sites, was presented at the annual American College of Cardiology Conference in Chicago.

The technique involved taking bone marrow samples from the patients and processing the marrow to extract stem cells. Doctors then injected the cells via catheter into the heart's left ventricle.

The injections, comprising some 100 million stem cells in all, were specifically targeted at damaged areas, identified by real-time electromechanical mapping of the heart.

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Stem cell treatment could repair heart damage

Proposition 71 stem cell research funds drying up

SACRAMENTO (KABC) -- Eight years ago voters agreed to fund California's stem cell agency, hoping it would yield new treatments for various conditions. Now the agency is running out of funds and any practical cures are still years away.

The California Institute for Regenerative Medicine (CIRM) is about to enter a crucial stage in stem cell research: going to clinical trials. The most promising experiments could cure diabetes, HIV, sickle-cell anemia and blindness in the elderly.

"You don't really get to find out whether the potential of the treatment is really going to be effective until you start to treat the patients," said Alan Trounson, president of the California Institute for Regenerative Medicine.

CIRM's board is discussing how much to allocate for that trial phase. Through voter-approved bonds under Proposition 71 (The California Stem Cell Research and Cures Act), it has already given out or spent half of the $3 billion, but despite the medical promise, there's little to show for it beyond basic research and several high-tech laboratories.

But the agency says the breakthroughs will come over the next few years, way ahead of the rest of the world.

"This would all be happening in California, all driven by this Proposition 71 money," said Trounson.

The bond money is expected to last only several more years. One option is to ask voters to approve more bonds, something taxpayer groups oppose.

"When people think about bond financing, they think about a bridge, a school, a canal," said Jon Coupal, president of the Howard Jarvis Taxpayers Association. "But stem cell research is just kind of out there."

Rancher Diana Souza says it would be a shame to stop public funding of stem cell research. Through trials at UC Davis Medical Center not financed by Prop. 71 money, she says stem cells helped restore full use of her severely fractured arm.

"I hope they can continue doing this because it is a miracle. It does work. And I have a good arm to prove it," said Souza.

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Proposition 71 stem cell research funds drying up

In Treatment of Child’s Heart Defect, Doctors Find a Stem-Cell Surprise

By Ron Winslow

Doctors at Yale University have successfully implanted a biodegradablescaffold seeded with a four-year-old girls own bone-marrowcells to help treat a serious heart defect, as WSJs Heartbeat column describes.

The tube about three inches long is made of polyester material similar to that used in the manufacture of dissolvable sutures. Six months after Angela Irizarrys surgery, it had disappeared, replaced by a bioengineered conduit that acts like a normal blood vessel.

The vanishing act for the scaffold was expected, but what happens to the cells, including stem cells, that spawned the new vessel?

Much to the researchers surprise, says Chris Breuer, the Yale pediatric surgeon leading the experimental tissue-engineering project, the cells go away too.

Stem cells and certain other bone-marrow cells have building-block properties that make them the foundation for more specialized cells that grow into the bodys various tissues and structures. Researchers have long believed that stem cells transplanted into heart tissue, for instance, would be a primary component of whatever new tissue that grew as a result.

A lot of people think that when you put cells in, they turn into whatever cells you want them to turn into, Breuer tells the Health Blog. Weve clearly shown that doesnt happen in our graft.

Indeed, in experiments performed to learn how the tubes morphed into blood vessels, Breuer and his colleagues transplanted their scaffold seeded with human cells into mice bred with deficient immune systems to prevent rejection of the cells. Within a few days, the human cellswere gone, replaced within the scaffold by mouse cells, including cells characteristic of those that line the inner wall of blood vessels.

Initially, I refused to believe it, Breuer says. I redid the experiment three different ways and saw the same thing every time.

The upshot: Transplanted cells that have a quality of stem cells dont buildnew parts themselves, he says.They cause the body to induce regeneration.

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In Treatment of Child’s Heart Defect, Doctors Find a Stem-Cell Surprise

Entest BioMedical Excited With Progress on 10 Dog Pilot Study of "Universal Donor" Stem Cell Treatment for Canine …

SAN DIEGO, CA--(Marketwire -03/21/12)- Entest BioMedical Inc. (OTCQB: ENTB.PK - News) (Pinksheets: ENTB.PK - News)

Entest BioMedical Inc. (OTCQB: ENTB.PK - News) (Pinksheets: ENTB.PK - News) and RenovoCyte LLC announced they have treated 8 canine patients of a 10 dog pilot study utilizing Canine Endometrial Regenerative Cells (CERC) licensed from Medistem Inc. (Pinksheets: MEDS.PK - News) in the treatment of canine osteoarthritis.

Previously, Entest announced the treatment of the first canine patient on November 18, 2011. Since that time Entest's McDonald Animal Hospital has treated 8 dogs in its 10 Dog Pilot Study with RenovoCyte. To date, all of the dogs participating in this study have shown dramatic improvement in their mobility and apparent reduction of pain.

Dr. Greg McDonald, Chief Veterinarian at McDonald Animal Hospital, said, "50 million CERC stem cells have been injected intravenously into eight dogs. Each dog selected for this study showed signs of arthritis. Follow-up blood tests, urinalysis and physical exams are now being scheduled for the patients that have already been treated. So far, all these canine patients have shown improvement."

Entest BioMedical Chairman David Koos stated, "Osteoarthritis is considered one of the most common causes of lameness in dogs, occurring in up to 30% of all dogs. It is caused by a deterioration of joint cartilage, followed by pain and loss of range of motion of the joint. We expect this treatment to relieve these animals from the pain associated with arthritis. This has extraordinary possibilities for dogs and may lead the way for human treatment of arthritic pain."

The CERC is a "universal donor" stem cell product that does not require matching with the recipient allowing for the generation of standardized products that can be delivered to the office of the veterinarian ready for injection. This is in stark contrast to current stem cell therapies utilized in veterinary applications which require the extraction, manipulation, and subsequent implantation of tissue from the animal being treated. CERC is the canine equivalent of Medistem's Endometrial Regenerative Cell (ERC). Medistem was recently granted approval from the FDA to initiate a clinical trial in human patients using its ERCs.

"We are extremely pleased with our research relationship with Entest BioMedical. This study of canine pets suffering from naturally occurring osteoarthritis is a better test model than laboratory induced disease because it will give us the opportunity for long term follow up of these patients. RenovoCyte sees this study as part of the supporting documentation that will be needed to obtain FDA approval for widespread usage of this therapy," said Shelly Zacharias, DVM, Director of Veterinary Operations, RenovoCyte, LLC.

A spokesperson for Entest noted the Company is also currently conducting a 10 dog safety study on its immune-therapeutic cancer vaccine for dogs, having treated 3 dogs so far.

About Entest BioMedical Inc.:Entest BioMedical Inc. (http://www.entestbio.com) is a veterinary biotechnology company focused on developing therapies that harness the animal's own reparative / immunological mechanisms. The Company's products include an immuno-therapeutic cancer vaccine for canines (ImenVax). ImenVax is less invasive and less traumatic in treating cancer. Additionally, the Company serves as the contract research organization conducting a pilot study on a stem cell based canine osteoarthritis treatment (developed by RenovoCyte LLC) utilizing a 'universal donor' stem cell. Entest is also building a network of veterinary hospitals (with its initial location in Santa Barbara, CA and anticipates acquiring other veterinary hospitals in California) -- which serve as distribution channels for its products.

DisclaimerThis news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

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Entest BioMedical Excited With Progress on 10 Dog Pilot Study of "Universal Donor" Stem Cell Treatment for Canine ...

Rescue dogs get stem cell treatment

(WRC/NBC) There is a breakthrough treatment using stem cellsthat's helping search-and-rescue dogs.

Theanimals played key roles on Sept. 11, 2001and in other disasters. Nowthe therapy is part of the recovery process after years of heroic work.

Red's first assignment as a search, rescue and recovery dog was at the Pentagon following the 911 attacks.

Her handler, Heather Roche said "she handled it like a pro."

"She didn't care about the machinery, bobcats moving the debris and all the people and everybody in their Tyvek suits looking funny with the respirators, and she didn't mind any of it and went to work," Roche said.

Now the 911 hero is in bad shape. All those years of rescue work, and a 12-foot fall from a ladder, have taken a toll.

Arthritis forced her into retirement in July.

On Tuesday, the 12-year-old black Labrador received a breakthrough stem cell treatment to ease her pain and give her more mobility.

The procedure was performed by Dr. John Herrity at the Burke Animal Clinic, where he's done more than two dozen stem cell operations.

Medivet America developed the technology and donated the cost of the procedure.

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Rescue dogs get stem cell treatment

Editorial: Medical case gets serious treatment

When a Bonita Springs doctor had his state license suspended after yet another stem-cell treatment case, his attorney issued a statement saying he had done nothing wrong and a second doctor was involved in treating a 77-year-old heart patient, who later died.

In response, rather than acquiesce, the state has gotten even more involved, issuing an emergency license restriction against that doctor, Konstantine K. Yankopolus, of Fort Myers.

That tells us the Florida Department of Health is focused on getting answers to what happened and assuring public health and safety is protected.

The lead doctor, Zannos Grekos, was in the news previously for stem-cell treatment on a 66-year-old breast cancer patient, who later fell, suffering severe brain damage and being taken off life support. The state ordered Grekos to suspend treatment with stem cells in Florida, though he still was allowed to conduct educational seminars about stem-cell therapy and arrange for patients to go for treatment in the Dominican Republic.

The state's order against Yankopolus says he knew Grekos was under a license restriction when Yankopolus agreed to assist in performing the stem-cell treatment for the now-deceased 77-year-old.

The order also notes that Yankopolus initially reported no stem-cell treatment was involved in the patient's care. That chart, the order says, was later changed by Yankopolus, who called it "a misunderstanding."

No wonder the state has questions about all this.

Integrity is at issue for these doctors and the medical community in general.

Also in the spotlight is how our state regulators choose to respond.

We can be grateful for Florida's Sunshine Laws for assuring public access to public records as this important investigation moves forward.

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Editorial: Medical case gets serious treatment