First-in-humans study introduces next generation … – Stem Cell Cafe

Apr 12

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 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.

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First-in-humans study introduces next generation ... - Stem Cell Cafe

Simple stem cell jab helps boost fitness in heart disease patients

Home News Health Simple stem cell jab helps boost fitness in heart disease patients A STEM cell injection could soon be available to cure heart disease after scientists tested the revolutionary new treatment in patients for the first time. Published: Fri, April 12, 2013

A stem cell injection to cure heart disease could soon be available

The heart failure breakthrough involves injecting patients with their own stem cells.

The quick and easy procedure saw doctors take bone marrow from the patients hips before injecting them directly into the heart to strengthen the muscle.

Heart pumping function improved within six months for every patient given the ground-breaking treatment. They also enjoyed improved fitness and could walk longer distances.

The trial offers new hope to the tens of thousands of people struck down by heart failure each year in the UK and could transform the lives of millions suffering the after-effects of a heart attack.

The research, published online in the Journal of the American College of Cardiology, took place at the Mayo Clinics Centre for Regenerative Medicine in Rochester, Minnesota.

I think its an exciting time where regenerative medicine is no longer science fiction

Dr Andre Terzic

Lead researcher Dr Andre Terzic said: I think its an exciting time where regenerative medicine is no longer science fiction. This study is providing clinical evidence for a new approach in cardiovascular regenerative medicine.

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Simple stem cell jab helps boost fitness in heart disease patients

Stem cell proliferation and differentiation observed within hydrogel

Apr. 11, 2013 Stem cells can be coaxed to grow into new bone or new cartilage better and faster when given the right molecular cues and room inside a water-loving gel, researchers at Case Western Reserve University show.

By creating a three-dimensional checkerboard -- one with alternating highly connected and less connected spaces within the hydrogel -- the team found adjusting the size of the micropattern could affect stem cell behaviors, such as proliferation and differentiation.

Inducing how and where stem cells grow -- and into the right kind of cell in three dimensions -- has proven a challenge to creating useful stem cell therapies. This technique holds promise for studying how physical, chemical and other influences affect cell behavior in three-dimensions, and, ultimately, as a method to grow tissues for regenerative medicine applications.

"We think that control over local biomaterial properties may allow us to guide the formation of complex tissues," said Eben Alsberg, an associate professor of Biomedical Engineering at Case Western Reserve. "With this system, we can regulate cell proliferation and cell-specific differentiation into, for example, bone-like or cartilage-like cells."

Oju Jeon, PhD, a postdoctoral researcher in Biomedical Engineering, pursued this work with Alsberg. Their work is described April 11, 2013 in the online edition of Advanced Functional Materials.

Hydrogels are hydrophilic three-dimensional networks of water-soluble polymers bonded, or crosslinked, to one another. Crosslinks increase rigidity and alter the porous structure inside the gel.

Alsberg and Jeon used a hydrogel of oxidized methacrylated alginate and an 8-arm poly(ethylene glycol) amine. A chemical reaction between the alginate and the poly(ethylene glycol) creates crosslinks that provide structure within the gel.

They tweaked the mix so that a second set of crosslinks forms when exposed to light. They used checkerboard masks to create patterns of alternating singly and doubly crosslinked spaces.

The spaces, which varied in size at 25, 50, 100 and 200 micrometers across, were evenly singly and doubly crosslinked.

Human stem cells isolated from fat tissue were encapsulated in the singly and doubly crosslinked regions. The doubly-crosslinked spaces are comparatively cluttered with structures. The cells grew into clusters in the singly-crosslinked regions, but remained mostly isolated in the doubly crosslinked regions.

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Stem cell proliferation and differentiation observed within hydrogel

Vatican Conference Hopes to Promote Truth on Adult Stem Cell Therapy

Doctors, Patients Speak on Personal Experiences Vatican City, April 11, 2013 (Zenit.org) Junno Arocho Esteves | 654 hits

During todays first session of the Second International Vatican Adult Stem Cell Conference, scientists, doctors and patients had an opportunity to share not only the advances in adult stem cell research, but also the potential it has to transform modern day health care.

The ethical debate on the use of embryonic stem cells has, according to Dr. Robin Smith, stifled the advances made in adult stem cells, which are derived from adult tissue samples. Dr. Smith serves as president of the Stem for Life Foundation as well as CEO of NeoStem, a leading developer in cellular therapy.

Stem Cell Therapy, especially using cultivated adult stem cells , can be used to regenerate dying tissue in the body of a person suffering debilitating diseases, such as Alzheimers, Parkinsons, or Multiple Sclerosis (MS).

In November 2001, we kicked of the first Stem Cell Conference. Since then, the entire world has awakened.

By improving the clinical outcomes, we can save hundreds of millions of lives, she said. We're not talking about medications, she continued. Were talking about repairing the heart with adult stem cells. Re-inserting these cells into a damaged organ is turning back the clock. In just 17 months, we have seen stunning advancements in leukemia treatments.

The work in stem cell research has only begun to be understood. The last conference did not have panels that discussed the benefits of cellular therapy on MS and diabetes. Dr. Smith stated that in the United States, $245 billion is spent on managing diabetes, which can cause blindness, stroke and amputations which is only getting worse.

Cellular therapy has the potential to rewrite the history of this disease, she said. Adult stem cells is something we can all agree upon; they are ethically pure. We can grasp whats inside of us and introduce them into the body.

The purpose of the conference, she concluded, was meant to inspire change and to promote the truth and promise behind stem cell science. We hope to show that you no longer have to choose between science and faith.

In Search of Hope

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‘Smart’ stem cells repair damage from heart failure – Stem Cell Cafe

Apr 12

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.

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'Smart' stem cells repair damage from heart failure – Stem Cell Cafe

StemCells, Inc. Enters Agreement to Receive $19.3 … – Stem Cell Cafe

NEWARK, Calif., April 11, 2013 (GLOBE NEWSWIRE) & StemCells, Inc. (STEM) today announced that it has entered into an agreement with the California Institute for Regenerative Medicine (CIRM) under which CIRM will provide approximately $19.3 million to help fund preclinical development and IND-enabling activities of the Company&s proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) for Alzheimer&s disease. The funding, which will be in the form of a forgivable loan, was awarded under CIRM&s Disease Team Therapy Development Award program (RFA 10-05) in September 2012. The goal of the research will be to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration within four years.

&With CIRM&s support, we are now able to lay the groundwork that could result in the world&s first neural stem cell trial in Alzheimer&s patients,& commented Martin McGlynn, President and CEO of StemCells, Inc. &Currently, there are no good treatment options for Alzheimer&s patients, and there aren&t any on the horizon, so it is clear that the field could benefit from creative approaches to this devastating and challenging disease. Our collaborators at UC Irvine have provided a compelling preclinical rationale to test the utility of our cells to restore memory in patients afflicted with this deadly condition.&

StemCells, Inc. will evaluate its HuCNS-SC cells as a potential therapeutic in Alzheimer&s disease in collaboration with researchers at the University of California, Irvine (UCI) led by Frank LaFerla, Ph.D., a world-renowned researcher in the field, and Matthew Blurton-Jones, Ph.D. Dr. LaFerla is Director of the Institute for Memory Impairments and Neurological Disorders (UCI MIND), and Chancellor&s Professor, Neurobiology and Behavior. Dr. Blurton-Jones is Assistant Professor, Neurobiology and Behavior, at UCI.

In July 2012, Dr. Blurton-Jones presented data at the Alzheimer&s Association Annual Meeting demonstrating that the Company&s neural stem cells restored memory and significantly enhanced synaptic function in two animal models relevant to Alzheimer&s disease. Importantly, these results did not require reduction in beta amyloid or tau that accumulates in the brains of patients with Alzheimer&s disease and account for the pathological hallmarks of the disease.

Terms and Conditions of the Loan

Loan funds are expected to be disbursed periodically over the four-year project period, with disbursements subject to a number of preconditions, including the achievement of certain progress milestones and compliance with certain financial covenants. The term of the loan is ten years, but may be extended under certain circumstances. The loan is unsecured and will bear interest at the one year LIBOR rate plus two however, the interest rate will increase by one percent each year after year five. The loan is forgivable, such that the Company&s obligation to repay the loan will be contingent upon the success of HuCNS-SC cells in Alzheimer&s disease. No warrants will be issued in connection with the loan, but the Company will owe various success milestone payments in the event of the product&s commercial success.

About Alzheimer&s Disease

Alzheimer&s disease is a progressive, fatal neurodegenerative disorder that results in loss of memory and cognitive function. Today there is no cure or effective treatment option for patients afflicted by Alzheimer&s disease. According to the Alzheimer&s Association, approximately 5.4 million Americans have Alzheimer&s disease, including nearly half of people aged 85 and older. The prevalence of Alzheimer&s disease is expected to increase rapidly as a result of the country&s aging population.

About CIRM

CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

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StemCells, Inc. Enters Agreement to Receive $19.3 ... - Stem Cell Cafe

Pro-lifers eye Kansas for top study of stem cells; no embryo use at …

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.

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Dr. Vincent Giampapa to Present at The Vatican Adult Stem Cell Conference on Adult Stem Cell Solutions to the Global …

CellHealth Institute founder to discuss new frontiers of cellular research.

Montclair, NJ (PRWEB) April 10, 2013

The invitation came directly from the Vaticans Pontifical Council for Culture, NeoStem, The Stem for Life Foundation and STOQ International as these organizations continue to promote their charter of raising global awareness on adult stem cell usage.

Dr. Vincent Giampapa will present during the third day, moderated by Dr. Max Gomez from WCBS-TV. Dr. Giampapa is a board-certified anti-aging physician and author of the first and only medical textbook on anti-aging medicine for medical doctors. He will present his research on reprogramming the function of older human stem cells at the University of Medicine and Dentistry New Jersey (UMDNJ).

The advancements being made in regenerative medicine and adult stem cell research are a reason for the global health care community to be extremely excited, said Dr. Vincent Giampapa, chief medical officer of CellHealth Institute. New ideas on how we age at the cellular level, particularly stem cells, are changing our approach to the aging process in general. The opportunity provided by The Vaticans Pontifical Council for Culture, NeoStem, The Stem for Life Foundation and STOQ International is a wonderful global platform for this discussion, and I am personally honored to play a part.

For more information, visit CellHealth.net.

About CellHealth Institute

CellHealth Institute (CHI) is a biotechnology company focused on cellular health that integrates breakthrough products and services with holistic lifestyle education. CHI collaborates with top-tier research universities and publicly traded biotech companies to offer fully integrated personalized health programs paired with scientific biomarker evaluations, as well as medical-grade supplements, including everycell, and advanced treatment through stem cell therapies. The organization is headquartered in New Jersey with an international regenerative medicine destination in Costa Rica set to open in 2014. CHI services and products allow people to take control of their own health at the most basic level their cells.

Jamie Vodden CellHealth Institute (480) 275-1203 Email Information

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Dr. Vincent Giampapa to Present at The Vatican Adult Stem Cell Conference on Adult Stem Cell Solutions to the Global ...

Mayo Clinic: Cardiopoietic 'smart' stem cells show promise in heart failure patients

Public release date: 10-Apr-2013 [ | E-mail | Share ]

Contact: Traci Klein newsbureau@mayo.edu 507-284-5005 Mayo Clinic

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 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.

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Mayo Clinic: Cardiopoietic 'smart' stem cells show promise in heart failure patients

Results from Cardio3BioSciences C-CURE® Trial Published in the Journal of the American College of Cardiology

MONT-SAINT-GUIBERT, Belgium, April 11, 2013 /PRNewswire/ --

Trial Demonstrates Statistically Significant Improvements in Heart Function and Exercise Tolerance with Cardiopoietic Stem Cell Therapy

Cardio3 BioSciences (C3BS) announces today the advanced publication of C-CURE (Phase II) trial results in the on-line edition of the Journal of the American College of Cardiology (JACC).1

The publication reported:

The publication concluded that the therapy with C3BS-CQR-1 (previously C-Cure) was feasible and safe with signals of benefit in chronic heart failure, meriting further definitive clinical evaluation.

The C-Cure trial was a prospective, multicenter, randomized study to evaluate the feasibility, safety, and efficacy of CQR-1 in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy. CQR-1 consists of the patient's own stem cells harvested from the bone marrow and engineered to become progenitors of new functional cardiac cells. Those cells behave identically to the cells lost to heart disease. In the C-Cure trial, all patients received optimal standard-of-care for heart failure, while treated group also received an intra-myocardial injection of CQR-1.

On the basis of these outcomes, C3BS has initiated a Phase III trial for CQR-1, called CHART-1 for Congestive Heart failure Cardiopoietic Regenerative Therapy. This is the first Phase III trial using organ specified cells for the treatment of ischemic heart failure and will recruit approximately 240 patients, with chronic advanced symptomatic heart failure underlining Cardio3 BioSciences' dedication and leadership in bringing regenerative therapies to patients. The primary endpoint of the trial integrates cardiac and clinical endpoints as recommended by the European Medicines Agency.

Dr Jozef Bartunek, Principal Investigator, said: "The Phase II trial demonstrates that cardiopoietic stem cell therapy is feasible, safe and with strong signals of efficacy. These results highlight the promise of such novel technology for optimized regenerative intervention in heart failure, bringing next generation therapies to patients. With Cardio3 BioSciences having started the follow-up Phase III trial, the cardiopoietic approach is at the forefront of this exciting field."

Dr Christian Homsy, CEO of Cardio3 BioSciences, added: "Publication of the C-Cure trial results in a journal as prestigious as JACC highlights the quality of the science underlying our lead product, CQR-1. We look forward to confirming the promising Phase II results, in our Phase III trial. Worldwide, this is the first pivotal Phase III study assessing such advanced regenerative product for the treatment of heart failure. We believe that the innovative science behind our product has the potential to revolutionize the treatment of this debilitating disease."

Prof. Dr. Andr Terzic, lead regenerative medicine specialist at Mayo Clinic in Rochester (MN), USA and Co-Principal Investigator of the C-Cure Clinical Trial, commented: "Heart failure is a major global challenge with the aging of the population and the shortage of donor organs. By introducing lineage guidance into the cell therapy protocol, the C-CURE trial provides initial clinical evidence for a new approach in cardiovascular regenerative medicine. Clinical translation of cardiopoietic stem cell therapy indicates favorable impact on myocardial remodeling, left ventricular ejection fraction, and global wellness. The C-CURE trial thus advances the paradigm of stem cell therapy, providing a rationale for further clinical validation."

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Results from Cardio3BioSciences C-CURE® Trial Published in the Journal of the American College of Cardiology