Wednesday, April 10, 2013

ROCHESTER, Minn. Translating a Mayo Clinic stem-cell discovery, an international team has demonstrated that therapy with cardiopoietic (cardiogenically-instructed) or "smart" stem cells can improve heart health for people suffering from heart failure. This is the first application in patients of lineage-guided stem cells for targeted regeneration of a failing organ, paving the way to development of next generation regenerative medicine solutions. Results of the clinical trial appear online of the Journal of the American College of Cardiology.

VIDEO ALERT: Audio and video resources are available on the Mayo Clinic News Network.

The multi-center, randomized Cardiopoietic stem cell therapy in heart failure (C-CURE) trial involved heart failure patients from Belgium, Switzerland and Serbia. Patients in the control group received standard care for heart failure in accordance with established guidelines. Patients in the cell therapy arm received, in addition to standard care, cardiopoietic stem cells a first-in-class biotherapeutic. In this process, bone marrow was harvested from the top of the patient's hip, and isolated stem cells were treated with a protein cocktail to replicate natural cues of heart development. Derived cardiopoietic stem cells were then injected into the patient's heart.

"The cells underwent an innovative treatment to optimize their repair capacity," says Andre Terzic, M.D., Ph.D., study senior author and director of the Mayo Clinic Center for Regenerative Medicine. "This study helps us move beyond the science fiction notion of stem cell research, providing clinical evidence for a new approach in cardiovascular regenerative medicine."

Every patient in the stem cell treatment group improved. Heart pumping function improved in each patient within six months following cardiopoietic stem cell treatment. In addition, patients experienced improved fitness and were able to walk longer distances than before stem cell therapy. "The benefit to patients who received cardiopoietic stem cell therapy was significant," Dr. Terzic says.

In an accompanying editorial, Charles Murry, M.D., Ph.D., and colleagues at the University of Washington, Seattle, say, "Six months after treatment, the cell therapy group had a 7 percent absolute improvement in EF (ejection fraction) over baseline, versus a non-significant change in the control group. This improvement in EF is dramatic, particularly given the duration between the ischemic injury and cell therapy. It compares favorably with our most potent therapies in heart failure."

The science supporting this trial is a product of a decade-long journey in decoding principles of stem cell-based heart repair. "Discovery of rare stem cells that could inherently promote heart regeneration provided a critical clue. In following this natural blueprint, we further developed the know-how needed to convert patient-derived stem cells into cells that can reliably repair a failing heart," says Dr. Terzic, underscoring the team effort in this endeavor.

Initial discovery led to the identification of hundreds of proteins involved in cardiogenesis, or the heart development process. The research team then identified which proteins are necessary in helping a stem cell become a reparative cell type, leading to development of a protein cocktail-based procedure that orients stem cells for heart repair. Such upgraded stem cells are called cardiopoietic or heart creative.

Mayo Clinic partnered with Cardio3 Biosciences, a bioscience company in Mont-Saint-Guibert, Belgium, for advanced product development, manufacturing scale-up, and clinical trial execution.

Link:
Stem Cells Show Promise in Heart Failure Patients

Long clouded by ethical concerns, medical treatments and research based on stem cells taken from adults or the umbilical cords of newborns but not human embryos are getting renewed support from lawmakers and religious leaders.

In the deep-red state of Kansas, lawmakers are waiting to see whether Gov. Sam Brownback, a Republican, will sign a bill making the University of Kansas Medical Center a hub for adult stem cell research and therapies in the region.

Mr. Brownback, a social conservative who promised to build a culture of life in the state, has signaled support for such a center. The bill passed the Legislature on Friday but has not reached his office, an aide said Wednesday.

If enacted, the new Midwest Stem Cell Therapy Center would focus on research and therapies exclusively using stem cells from human adults and cord blood and tissue. Stem cells harvested from human embryos or tissues from aborted fetuses would be specifically prohibited.

Treatments exploiting the unique qualities of stem cells biological cells with the ability to reproduce and develop into specialized cells used throughout the body have been used for decades to cure some diseases, and researchers say the approach has exciting potential to treat or cure maladies such as diabetes, multiple sclerosis, cancer, cardiovascular disease, spinal cord injuries, Parkinsons disease and autoimmune diseases.

However, political, legal and cultural battles have abounded since scientists discovered in the 1990s that they could use human embryos as sources for harvesting stem cells. Pro-life and Catholic groups denounced the process because it destroys the embryos, but scientists said such research can be carried out ethically, especially when the benefits are so promising.

The center is being proposed after seven years of efforts to create partnerships around the adult stem cell approach, said Kathy Ostrowski, legislative director of Kansans for Life, sidestepping the moral minefield that has held back research in the United States.

The University of Kansas Medical Center is active in adult stem cell clinical trials and research, and this first-of-its-kind center would be an economic engine in this strategic field as well as a gold mine for treatments and cures, Ms. Ostrowski said.

The proposed Midwest Stem Cell Therapy Center which would partner with the Blood and Marrow Transplant Center of Kansas would produce clinical-grade stem cells and conduct clinical trials with adult stem cell therapies, creating opportunities for people with diseases or injuries to participate in such trials.

During legislative hearings on the proposed stem cell center, no one testified against the idea. However, critics noted that while Kansas lawmakers established a way for donations to come to the new center, they didnt authorize any state money for it.

Original post:
Pro-lifers eye Kansas for top study of stem cells; no embryo use at proposed center

Released: 4/10/2013 9:55 AM EDT Source Newsroom: Mayo Clinic

VIDEO ALERT: Audio and video resources are available on the Mayo Clinic News Network.

First-in-humans study introduces next generation cell therapy

Newswise ROCHESTER, Minn. -- Translating a Mayo Clinic stem-cell discovery, an international team has demonstrated that therapy with cardiopoietic (cardiogenically-instructed) or smart stem cells can improve heart health for people suffering from heart failure. This is the first application in patients of lineage-guided stem cells for targeted regeneration of a failing organ, paving the way to development of next generation regenerative medicine solutions. Results of the clinical trial appear online of the Journal of the American College of Cardiology.

The multi-center, randomized Cardiopoietic stem cell therapy in heart failure (C-CURE) trial involved heart failure patients from Belgium, Switzerland and Serbia. Patients in the control group received standard care for heart failure in accordance with established guidelines. Patients in the cell therapy arm received, in addition to standard care, cardiopoietic stem cells -- a first-in-class biotherapeutic. In this process, bone marrow was harvested from the top of the patients hip, and isolated stem cells were treated with a protein cocktail to replicate natural cues of heart development. Derived cardiopoietic stem cells were then injected into the patients heart.

The cells underwent an innovative treatment to optimize their repair capacity, says Andre Terzic, M.D., Ph.D., study senior author and director of the Mayo Clinic Center for Regenerative Medicine. This study helps us move beyond the science fiction notion of stem cell research, providing clinical evidence for a new approach in cardiovascular regenerative medicine.

Every patient in the stem cell treatment group improved. Heart pumping function improved in each patient within six months following cardiopoietic stem cell treatment. In addition, patients experienced improved fitness and were able to walk longer distances than before stem cell therapy. The benefit to patients who received cardiopoietic stem cell therapy was significant, Dr. Terzic says.

In an accompanying editorial, Charles Murry, M.D., Ph.D., and colleagues at the University of Washington, Seattle, say, Six months after treatment, the cell therapy group had a 7 percent absolute improvement in EF (ejection fraction) over baseline, versus a non-significant change in the control group. This improvement in EF is dramatic, particularly given the duration between the ischemic injury and cell therapy. It compares favorably with our most potent therapies in heart failure.

The science supporting this trial is a product of a decade-long journey in decoding principles of stem cell-based heart repair. Discovery of rare stem cells that could inherently promote heart regeneration provided a critical clue. In following this natural blueprint, we further developed the know-how needed to convert patient-derived stem cells into cells that can reliably repair a failing heart, says Dr. Terzic, underscoring the team effort in this endeavor.

Initial discovery led to the identification of hundreds of proteins involved in cardiogenesis, or the heart development process. The research team then identified which proteins are necessary in helping a stem cell become a reparative cell type, leading to development of a protein cocktail-based procedure that orients stem cells for heart repair. Such upgraded stem cells are called cardiopoietic or heart creative.

Continue reading here:
Cardiopoietic 'Smart' Stem Cells Show Promise in Heart Failure Patients

by Elizabeth Dunbar, Minnesota Public Radio

April 11, 2013

ST. PAUL, Minn. Treating heart failure patients with a special type of stem cell can improve their condition, according to a new Mayo Clinic study published this week.

The researchers used proteins to instruct the stem cells to behave like heart cells. All of the 45 patients in the clinical trial who received the "smart" stem cells saw more improvements in heart health than another group of patients who were given the standard treatments for heart failure.

The stem cell group's hearts were able to pump more robustly and the patients showed improvements in physical fitness, such as being able to walk longer distances than the patients who didn't receive the cells.

Dr. Andre Terzic, who led the research and is director of Mayo's Center for Regenerative Medicine, said it is the first published study in which smart stem cells were tested on humans.

"I think it's an exciting time where regenerative medicine is no longer science fiction but it's increasingly becoming considered as a viable option for our patients, in particular the patients [who] have many unmet needs that current therapies cannot address," Terzic said.

Terzic said the treatment will be tested on a group of 300 patients before researchers ask federal regulators to approve it, but he said he is hopeful because there were no patients in the current study who saw negative results. The study is published in the Journal of the American College of Cardiology.

Terzic said he also thinks the concept can be applied to other conditions.

"It will be, for example, fantastic to see cells instructed to be more neuron-like, to maybe go after some of the neurological disorders, or to be more bone-like to help an orthopedic surgery and so on," he said.

See more here:
Mayo: 'Smart' stem cells for heart failure patients

Washington, April 11 : Researchers have found that therapy with cardiopoietic (cardiogenically-instructed) or "smart" stem cells can improve heart health for people suffering from heart failure.

This is the first application in patients of lineage-guided stem cells for targeted regeneration of a failing organ, paving the way to development of next generation regenerative medicine solutions.

The multi-center, randomized Cardiopoietic stem cell therapy in heart failure (C-CURE) trial involved heart failure patients from Belgium, Switzerland and Serbia.

Patients in the control group received standard care for heart failure in accordance with established guidelines. Patients in the cell therapy arm received, in addition to standard care, cardiopoietic stem cells - a first-in-class biotherapeutic. In this process, bone marrow was harvested from the top of the patient's hip, and isolated stem cells were treated with a protein cocktail to replicate natural cues of heart development.

Derived cardiopoietic stem cells were then injected into the patient's heart.

"The cells underwent an innovative treatment to optimize their repair capacity," said Andre Terzic, M.D., Ph.D., study senior author and director of the Mayo Clinic Center for Regenerative Medicine.

"This study helps us move beyond the science fiction notion of stem cell research, providing clinical evidence for a new approach in cardiovascular regenerative medicine," the researcher stated.

Every patient in the stem cell treatment group improved. Heart pumping function improved in each patient within six months following cardiopoietic stem cell treatment. In addition, patients experienced improved fitness and were able to walk longer distances than before stem cell therapy.

"The benefit to patients who received cardiopoietic stem cell therapy was significant," Dr. Terzic said.

Read the original:
'Smart' stem cells repair damage from heart failure

A horse is given an injection of stem cells in a bid to promote healing in a tendon injury.

Lauren Schnabel/Jessica Cross/Cornell Univ.

Patients seeking unproven stem-cell therapies in the United States often run up against government restrictions. But Vintage Vinty Mark of Lovettsville, Virginia, had no difficulty getting such injections to treat an injured tendon in his leg. The leg improved dramatically, and Vinty went back to training to be a racehorse.

New guidance from the US Food and Drug Administration (FDA) could, however, soon rein in veterinary uses of stem cells, a practice that has exploded in the United States over the past decade, even though most therapies are unproven. Many researchers and veterinarians say that the guidance, a draft of which the agency plans to issue by the end of the year, is overdue. But others worry that FDA interference could hamper research that could benefit animals and their human companions.

In the absence of clear regulations, the industry has burgeoned. Vet-Stem, a company based in Poway, California, has provided stem-cell treatments to more than 5,000 horses, 4,300 dogs and 120 cats since treating its first patient in 2004. Kits provided by MediVet America, based in Nicholasville, Kentucky, have been used to produce stem-cell injections for more than 10,000 horses since 2010. University veterinary departments, independently or through spin-off companies, have offered such services to thousands more animals. Veterinarians send patients tissue samples to the centres to have cells extracted or, increasingly, turn to kits that allow them to extract the cells in-house.

Stem cells are most often used to treat horses, dogs and cats, but clinicians have also sought to use them to repair a lumbar fracture in a Bengal tiger and arthritis in pigs. Researchers have also found stem cells in the fat of bottlenose dolphins, raising hopes for treating the marine-mammal versions of liver disease and type 2 diabetes. Theres not a large vet practice thats not using them, says Wesley Sutter, a veterinarian at Lexington Equine Surgery and Sports Medicine in Kentucky. Some claim [the treatment] cures everything.

Many veterinarians offer unproven stem-cell therapies to satisfy demanding customers, says Dori Borjesson, who specializes in veterinary medicine at the University of California, Davis. Clinicians are sucked into giving treatment even when theres not research to back up uses, she says.

Like the treatments sought by humans, most of those used in animals involve mesenchymal stem cells (MSCs), which can mature into a wide variety of cell types, including bone and cartilage, and have been shown to have anti-inflammatory and other beneficial effects. MSCs are extracted from fat or bone marrow and can be cultured or prepared for injection in concentrated form.

The FDAs position on the use of MSCs in humans is clear. It says that the cells are drugs and therefore must be proved safe and effective before they can be used in treatment, except under certain conditions. No MSC treatments have been approved. But the FDA has different regulations for veterinary medicine, and these do not clearly address MSCs. The agency has not approved any veterinary stem-cell therapies, but neither has it cracked down on any. This is in stark contrast to its high-profile actions against purveyors of unproven human stem-cell treatments, such as Celltex Therapeutics of Sugar Land, Texas,which treated patients with MSCs until the FDA stepped in last September.

That doesnt mean that the agency is not concerned, says Lynne Boxer, a veterinary medical officer in the FDAs Office of New Animal Drug Evaluation in Rockville, Maryland. As with any type of drug product, there are risks and benefits, she says. With stem cells, there is the potential for disease transmission and tumour formation. She declines, however, to say whether current practices are against FDA rules, or to elaborate on what the new draft guidance is likely to contain.

Originally posted here:
Stem cells boom in vet clinics