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Stem cell treatment helps heal stroke victims

Posted: June 16, 2012 at 3:12 am

"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."

The six patients suffered strokes between six months and five years before they were treated, and all had been left with limb weakness.

The patients were assessed using the National Institutes of Health Stroke Scale which ranked the first five patients with a median score of eight before the treatment and four points three months afterwards.

The sixth patient was treated less than three months ago. Six further patients will be treated as part of this Phase 1 trial.

Professor Muir said he was "intrigued" by the early results.

He added: "We know that if you're involved in a trial you are going to see patients change in behaviour, particularly if you're doing something invasive, so we need to be very cautious indeed in interpreting these results.

"However, that said, it is not something we'd anticipated seeing in this group of patients."

Further trials are needed to establish whether stem cells actually help the brain repair damaged tissue.

Michael Hunt, chief executive officer of the company developing the treatment, ReNeuron, said: "The clinical trial is primarily a safety study and we must therefore treat any of the observed early indications of functional benefit with considerable caution at this stage.

"That said, we remain encouraged by the results seen in the study to date and we look forward to providing further updates."

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Unveilling stem cells

Posted: June 15, 2012 at 8:13 pm

Unveilling stem cells

LAWRENCE SERETSE Correspondent

Cryo-Save, the European company that intends to establish the first stem cell bank in Botswana says stem cells do not have just one function. They can themselves become or create other types of cells such as blood cells, brain cells, tissue cells, muscle cells and the like. Stem cells can be found in every person but they are much more numerous in the body of a foetus.

There are three types of stem cell banking namely, the baby stem cell banking which is the preservation and storage of cord blood and umbilical cord tissue. Adult stem cell banking is the preservation and storage of peripheral blood (from blood stream for bone marrow transplants) and fatty tissue stem cells.

The reproductive cell banking deals with the preservation and storage of eggs and sperm for future fertility treatments or artificial insemination purposes. Studying stem cells helped humans understand how they transform into the dazzling array of specialised cells that make us what we are. Some of the most serious medical conditions, such as cancer and birth defects, are caused by problems that occur somewhere in this process. A better understanding of normal cell development has allowed scientists to understand and perhaps correct the errors that cause these medical conditions. Many support stem cell research because it has the potential to provide solutions to a wide variety of medical conditions and diseases.

Stem cell research could even lead to a cure for some of the most traumatic injuries and diseases. Stem cell treatments cure over 70 diseases and disorders like Leukemia, Lymphoma, blood cancers, bone marrow disorders like Aplastic anaemia, sickle cell, Diabetes, Alzheimer's Disease, heart disease, stroke, birth defects, spinal cord injuries, ability to replace or repair organs and cancer.

This is just half of it. If one just looked at the benefits one might wonder why stem cell treatments are not in wide use. The shortcomings of stem cell research are often fears of what could result from such knowledge and the moral implications of using the stem cells. There are worries that humans should not try to play God. "Relating bodies have to pay extra caution and determine if we really need these banks. Again, some researchers may be coming to dig stem cells in Botswana, since there maybe restrictive laws in their countries.

"The unsuspecting citizens may end up giving up their stem cells for money," says Iqbal Chand, the CEO of Diagnofirm Medical Laboratories. He gave a scenario from recent publications that a patient in Berlin was cleared of HIV after stem cell treatment for leukemia.

"We do not even know how true it is and if it was the stem cells that cured his HIV. Even if it is, it is one person in a million so there is no assurance," Chand pointed out.

Another big issue with stem cells research is superstition. In most African communities, the umbilical cord must be buried after birth because it is believed that anyone with access to it could exert some spiritual influence on the child. This has led to uncertainty towards cord tissue and cord blood storage in most African societies. However, with the success of transplants making the headlines, more and more people are willing to donate adult stem cells to save lives.

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Stem Cells from Corpses

Posted: June 15, 2012 at 8:13 pm

Researchers pull viable cells from bodies that had been dead for more than 2 weeks.

By Bob Grant | June 15, 2012

Wikimedia Commons, Robert Lawton

Stem cells stay alive and in a dormant state for more than 2 weeks after a person passes away, according to researchers in France. A team of scientists at the Pasteur Institute in Paris have successfully recovered viable stem cells from muscle tissue in dead bodies that had been kept at 4 degrees Celsius for 17 days, later using the cells to generate new, functional muscle cells. They report their findings in this weeks issue of Nature Communications.

Previously, researchers thought that stem cells could only remain viable in corpses for 1 or 2 days. But Pasteur Institute histologist and neuropathologist Fabrice Chrtien, senior author on the paper, said that stem cells may even remain viable for more than 17 days. Maybe they can also resist longer, he told LiveScience.

The stem cells recovered from the human corpses were in a dormant state, characterized by reduced metabolic activity and elevated levels of reactive oxygen species. Chrtien and his collaborators suggested that the low oxygen environment in which the cells sat likely contributed to their quiescence and subsequent retention of viability.

This discovery could form the basis of a new source, and more importantly new methods of conservation, for stem cells used to treat a number of pathologies, according to a statement from the Pasteur Institute announcing the discovery.

By Jef Akst

New research finds that older men have children and grandchildren with longer telomeres, pointing to possible health benefits of delayed reproduction.

By Tia Ghose

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Stem cells stay alive for 17 days in dead bodies

Posted: June 15, 2012 at 8:13 pm

London, June 15 : Scientists have revealed that some stem cells can lay dormant for more than two weeks in a dead person and then be revived to divide into new, functioning cells.

The research unlocks further knowledge about the versatility of these cells, touted as a future source to replenish damaged tissue.

"Remarkably, skeletal muscle stem cells can survive for 17 days in humans and 16 days in mice post-mortem, well beyond the one to two days currently thought," the Daily Mail quoted the statement of scientists.

The researchers led by Fabrice Chretien of the Pasteur Institute in Paris, found that the stem cells retained their ability to differentiate into perfectly functioning muscle cells.

"This discovery could form the basis of a new source, and more importantly new methods of conservation, for stem cells used to treat a number of pathologies," the researchers said.

Stem cells are infant cells that develop into the specialised tissues of the body.

The latest findings have sparked great excitement as they offer hopes of rebuilding organs damaged by disease or accident.

The Pasteur Institute team found that to survive in adverse conditions, skeletal muscle stem cells lower their metabolism to enter a dormant state, using less energy.

The team then also looked at stem cells taken from bone marrow, where blood cells are produced.

These remained viable for four days after death in lab mice and retained their ability to reconstitute tissue after a bone marrow transplant.

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Orgenesis’ Sarah Ferber, Ph.D on Using a Diabetes Patient’s Own Liver Cells as a Novel Source of Insulin

Posted: June 15, 2012 at 8:12 pm

Diabetes currently afflicts approximately 285 million people worldwide, about 6.4 percent of the global population. The World Health Organization projects that this number is set to rise to 366 million by the year 2030.

According to the American Diabetes Association, 1.9 million new cases of diabetes are diagnosed in people aged 20 years and older in 2010, an estimated 7.0 million Americans have undiagnosed diabetes, and another 79 million have pre-diabetes. In addition, approximately 25.8 million children and adults in the United States-8.3% of the population-have diabetes.

Several kinds of treatment for diabetes are currently available, but all of them present specific drawbacks to the patient. For example, insulin therapy can trigger everything from weight gain to hypoglycemia, and its administration must be constantly controlled and monitored by the patient. A novel approach to this problem is currently being pursued by a small biotech company named Orgenesis, which initiated its approach by asking the following question: What if a diabetes patient`s own cells-extracted from his or her own mature tissue-could be made to produce insulin, secreting the compound automatically when needed? This particular variety of cell therapy is a form of what has been dubbed "autologous cell replacement."

For years, the concept of harvesting stem cells and re-implanting them into one`s own body to regenerate organs and tissues has been embraced and researched in animal models. The treatment being developed by Orgenesis consists of several steps. First, a standard liver biopsy is taken from a diabetes patient in a clinical center and sent to a laboratory. In the lab, the liver cells are first propagated in vitro. Some of these cells are then manipulated with a therapeutic agent (i.e., the "master regulator" PDX-1 that governs pancreas development, or additional pancreatic transcription factors in adenovirus-vector) that converts a subpopulation of liver cells into different cells with pancreatic islet phenotype and function.

The therapeutic agent triggers a cascade of events, converting the cells into "autologous insulin-producing" (AIP) cells. These cells now act similarly to the beta cells that produce insulin in the pancreas of healthy individuals. Insulin is not only produced, but also stored and secreted in a glucose-regulated manner.

Back at the clinical center, the newly formed AIP cells are then transplanted in a standard infusion procedure back to the patient`s liver where they secrete insulin. Since the initial liver cells were taken from the patient himself or herself, there is no chance of rejection. Orgenesis has successfully tested its technology in mice, rats and pigs, and is working toward initiating clinical trials in humans.

The surprising capacity to activate pancreatic lineage in the liver was first demonstrated in mice by systemic PDX-1 administration using recombinant adenovirus gene delivery. PDX-1 plays a dual and central role in regulating both pancreas organogenesis in embryo and beta cell function in adults. The capacity of PDX-1 to direct pancreas development has been demonstrated in mature fully differentiated liver in vivo, both in mice and in Xenopus, possibly via a process called trans-differentiation. This describes an irreversible switch of one type of differentiated cell into another differentiated cell. AIP therapy seems to be safer than other options, as it does not alter the host genome but only alters the set of expressed genetic information that seems to be highly specific to the reprogramming protocol. In addition, no human organ donations or embryo-derived cells are required.

This form of therapy, if proven to be workable in clinical trials, would provide several advantages over other insulin-dependent diabetes therapies currently being studied. First, it frees the patient from daily involvement in the monitoring of blood glucose levels, numerous insulin injections and watching food intake and exercise. Indeed, the body itself is now continuously controlling blood glucose levels. In addition to avoiding the chance of autoimmune rejection, the procedure is only minimally invasive.

In summary, the use of adult human liver cells for generating functional insulin-producing tissue may pave the way to autologous implantations, thus allowing the diabetic patient to be the donor of his or her own insulin-producing tissue.

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Bio-Matrix Scientific Group Announces David Audley, the Founder of International Cellular Medicine Society, Has Joined …

Posted: June 15, 2012 at 8:11 pm

SAN DIEGO, CA--(Marketwire -06/15/12)- Bio-Matrix Scientific Group (BMSN) (BMSN) announced today the appointment of David Audley to the advisory board of Its Regen BioPharma subsidiary. Mr. Audley will advise Regen BioPharma on strategic leveraging of national and international clinical research resources. Mr. Audley is viewed by the Company as a key component in the commercialization of stem cell intellectual property. Additionally, it is anticipated that he will assist in raising international awareness for the regenerative therapies being developed by the Company.

In his function as executive director and CEO of the International Cellular Medicine Society (ICMS), Mr. Audley has spearheaded development and implementation of global guidelines for accreditation of stem cell clinics. Under his leadership, the ICMS has grown from a loose association of a handful of physicians to a major international standards organization with over 3500 members from 36 countries. He is a strong advocate for stem cell therapy development and implementation, and is the chief architect of the ICMS accreditation program that is currently evaluating the practices of nearly 20 facilities in a dozen countries. Mr. Audley also has strong professional relationships with Ministries of Health and governmental agencies in South America, Asia and the Middle East.

"My work at ICMS exposes me to the tremendous ability of stem cell therapeutics to alleviate human suffering. Unfortunately, business models have not caught up with the medical reality. Regen BioPharma is unique in that to my knowledge they are the first group to develop a model that accelerates development of stem cell therapeutics in a win-win situation for investors and patients," said David Audley.

"Mr. Audley has made a substantial impact in the clinical translation of stem cell therapeutics by establishing standards, accreditations, an Institutional Review Board (IRB), and partnerships with major organizations such as the AABB," said Christopher Mizer, President of Regen BioPharma. "We are extremely excited to work side by side with Mr. Audley in accelerating access of new stem cell therapies for patients."

About Bio-Matrix Scientific Group, Inc. and Regen BioPharma, Inc.:

Bio-Matrix Scientific Group, Inc. (BMSN) (BMSN) is a biotechnology company focused on the development of regenerative medicine therapies and tools. The Company is focused on human therapies that address unmet medical needs. Specifically, Bio-Matrix Scientific Group, Inc. is looking to increase the quality of life through therapies involving stem cell treatments. These treatments are focused in areas relating to cardiovascular, hematology, oncology and other indications.

Through Its wholly owned subsidiary, Regen BioPharma, it is the Company's goal to develop translational medicine platforms for the rapid commercialization of stem cell therapies. The Company is looking to use these translational medicine platforms to advance intellectual property licensed from entities, institutions and universities that show promise towards fulfilling the Company's goal of increased quality of life. To follow our development, visit us at http://www.regenbiopharma.com.

Disclaimer

This 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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ViaCyte Appoints Dr. Paul Laikind Chief Executive Officer

Posted: June 15, 2012 at 4:17 pm

SAN DIEGO, June 15, 2012 /PRNewswire/ --ViaCyte, Inc. today announced the appointment of seasoned entrepreneur, Paul Laikind, Ph.D., as President & Chief Executive Officer. Allan Robins, Ph.D., who was serving as Acting CEO, will continue in his role as Vice President & Chief Technology Officer. ViaCyte is a leading pre-clinical company developing a novel cell therapy product for the treatment of insulin dependent diabetes.

Dr. Laikind brings over 25 years of leadership experience in the biotechnology and life sciences industry to ViaCyte. He is a serial entrepreneur, who co-founded three San Diego companies, Gensia Pharmaceuticals Inc., Viagene Inc., and Metabasis Therapeutics Inc., serving in various executive positions including President and CEO. All three companies went public and were eventually acquired. Most recently, he served as Chief Business Officer and Senior Vice President of Business Development at the Sanford-Burnham Medical Research Institute.

"Paul brings to ViaCyte a wealth of experience in managing new businesses based on highly innovative life sciences technologies," said Fred Middleton, Chairman of ViaCyte. "We are pleased to have him join to lead ViaCyte through our next phase of development in bringing our transformative stem cell therapy to patients with diabetes. We believe Paul's leadership and business development skills will greatly assist us in our strategy to be a leader in regenerative medicine therapy and to capitalize on our current technology leadership position in the development of stem cell therapy."

As Sanford-Burnham's first Chief Business Officer, Dr. Laikind set a new direction for the Institute's business development activity through a combination of licensing and strategic partnerships with large pharmaceutical organizations, including collaborations with Pfizer's Centers for Therapeutic Innovation, Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, and Takeda Pharmaceutical. Working with the Institute's leadership team he helped establish a sophisticated infrastructure for advanced drug discovery and development at Sanford-Burnham.

Prior to Sanford-Burnham, Dr. Laikind served as President & CEO from 1999-2008 for Metabasis Therapeutics, which developed new therapies for metabolic and liver diseases. Dr. Laikind co-founded Gensia Pharmaceuticals in 1986, was a board member of the company and held various executive leadership positions. While at Gensia he was responsible for establishing a number of important strategic partnerships. In 1997, he was part of a team that restructured Gensia to focus on specialty pharmaceuticals. The restructured company was renamed Gensia Sicor and went on to be acquired for over $3 billion by Teva Pharmaceutical Industries in 2004. Soon after founding Gensia, he was co-founder of Viagene, a gene therapy company. Viagene completed an initial public offering in 1993 and was acquired in 1995 by Chiron Inc., now a subsidiary of Novartis Vaccines & Diagnostics.

Dr. Laikind earned his Ph.D. in biochemistry from the University of California, San Diego and is the inventor on a number of key patents.

"ViaCyte addresses one of the largest commercial and medical opportunities in stem-cell-derived therapeutics, and its team is internationally recognized for its scientific leadership," said Dr. Laikind. "I look forward to working with ViaCyte through clinical development and market launch of its first important product that promises to change the way we treat insulin dependent diabetes."

About ViaCyte

ViaCyte is a preclinical cell therapy company focused on diabetes. The Company's technology is based on pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin in response to blood glucose levels. ViaCyte's goal is long term insulin independence without immune suppression, and without hypoglycemia and other diabetes-related complications.

ViaCyte is a private company headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine.

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Seattle Genetics Highlights Updated Survival Data from ADCETRIS® Pivotal Trial in Patients with Relapsed or Refractory …

Posted: June 15, 2012 at 8:11 am

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced updated survival data from a pivotal clinical trial of single-agent ADCETRIS (brentuximab vedotin) in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.

Heavily pretreated Hodgkin lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options, said Scott Smith M.D., Ph.D., Loyola University Medical Center. These updated overall survival results from the pivotal trial are encouraging and demonstrate that ADCETRIS may play an important role in the treatment of patients with relapsed or refractory disease.

Long-term Follow-up Results of an Ongoing Pivotal Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma

A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5months. Data, to be presented by Dr. Smith, include:

Patients received 1.8milligrams per kilogram of ADCETRIS every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16cycles. Patients received a median of nine cycles of ADCETRIS while on trial. The median age of patients in the pivotal trial was 31 years. Enrolled patients had received a median of 3.5 (range 113) prior cancer-related systemic therapies, excluding ASCT. Seventy-one percent of patients had primary refractory disease, defined in the study protocol as patients who relapsed within three months of attaining CR or failed to achieve a CR, and 42 percent had not responded to their most recent prior therapy.

Details of the oral presentation are as follows:

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

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Stem cells 'help' stroke patients

Posted: June 15, 2012 at 8:11 am

14 June 2012 Last updated at 07:25 ET By Eleanor Bradford BBC Scotland Health Correspondent

The first patients to take part in a clinical trial of a stem cell treatment for stroke have seen reductions in their disability, according to doctors.

Six patients in the west of Scotland had human stem cells inserted close to the damaged part of their brain.

After receiving the treatment, they saw improvements in the limb weakness they suffered as a result of their stroke.

Howeve, doctors have cautioned against reading too much into the early results of the clinical trial.

It is the world's first trial of a neural stem cell therapy for stroke.

Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

The trial is being conducted at the Institute of Neurological Sciences at the Southern General Hospital in Glasgow, and is being led by Glasgow University neurologist Professor Keith Muir.

He said: "So far we've seen no evidence of any harmful effects. We're dealing with a group of people a long time after a stroke with significant disability and we don't really expect these patients to show any change over time.

"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."

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First stem cell vein implant helps young girl

Posted: June 15, 2012 at 3:14 am

By Denise Mann HealthDay Reporter

THURSDAY, June 14 (HealthDay News) -- In what is being reported as a scientific first, Swedish doctors were able pair the groin vein of a dead donor with stem cells from a young girl and implant the healthy vein into the girl, improving both blood flow in her lower body and her quality of life.

The 10-year-old had a rare condition where her portal vein, which is located in the abdomen and tasked with carrying blood from the bowels and other abdominal organs to the liver, was blocked. If this vein is blocked, liver disease, heart failure and certain cancers may develop. The relatively rare condition may also cause weight loss, nausea and pain.

Details of the feat are published online June 14 in The Lancet.

U.S experts were quick to caution that the procedure has only been accomplished in one patient, but they agreed that it could be a game-changer with applications that go far beyond this particular condition.

In the procedure, the transplant team from the University of Gothenburg in Sweden first took a segment of the groin vein from a dead donor, and stripped it of all living cells. They then injected stem cells taken from the girl's own bone marrow into the remaining vein. Two weeks after this seeding, the newly grown graft was implanted in the girl.

There were no complications, and the procedure immediately restored normal blood flow. In the year following the operation, the girl grew taller and gained weight. Her blood flow later decreased, and she underwent a second vein replacement surgery a year after the first. Her quality of life has improved since the procedures, and she is now able to take increasingly long walks and participate in light gymnastics. Importantly, she is showing no sign of rejecting the new vein even though she is not taking any immunosuppressive drugs.

"The new stem cells-derived graft resulted not only in good blood flow rates and normal laboratory test values but also, in strikingly improved quality of life for the patient," wrote the team led by Dr. Michael Olausson, of Sahlgrenska University Hospital in Gothenburg. "The work also establishes the feasibility and safety of a novel paradigm for treatment, in cases of venous insufficiency, obstructed veins or inadequate autologous [from the patient] veins."

Today, surgeons may approach such cases by harvesting veins from a patient's neck or leg to re-route around a blockage elsewhere. This can be traumatic and is associated with its own set of risks and complications. In addition, not everyone has healthy veins that can be used in this manner. This is where the new stem cell vein grafting procedure could play an important role.

"This is an interesting article and an exciting first step," said Dr. Scott Pilgrim, an attending pediatric cardiologist at Steven and Alexandra Cohen Children's Medical Center of New York, in New Hyde Park. "If this outcome turns out to be reproducible and is studied in a larger, defined population with a well-designed, controlled trial, I feel this advance could be a watershed moment in developing new, novel strategies for vascular and cardiothoracic surgeons."

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