StemCell Therapy

SAN DIEGO, CA--(Marketwire -06/26/12)- Bio-Matrix Scientific Group, Inc. (BMSN) (BMSN) announced today Thomas E. Ichim, PhD has joined the management team of its Regen BioPharma, Inc. subsidiary as Chief Scientific Officer and Director of Research. Regen BioPharma is the company's translational medicine platform for the rapid commercialization of stem cell therapies.

Dr. Ichim is one of the leading authorities in the world on stem cell biology. To date, he has published 82 peer-reviewed articles and is co-editor of the textbook RNA Interference: From Bench to Clinical Translation. He is also inventor on over 30 patents and patent applications. He currently serves as the CEO of Medistem, Inc., was formerly chief of scientific development, and is the scientific founder / co-founder of Medvax Pharma, ToleroTech, bioRASI, and OncoMune.

David Koos, Chief Executive Officer of Bio-Matrix Scientific Group, stated: "Dr. Ichim is a seasoned biotechnology executive with a track record of scientific excellence. We now have a world-class team to lead our efforts to commercialize stem cell therapies."

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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Bio-Matrix Scientific Group, Inc. Recruits Senior Scientist for Its Regen BioPharma Subsidiary

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who read it, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it does not remedy the problems quickly. The former official asked not to be identified.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Rules take effect Friday

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

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FDA report faults Houston-area stem-cell company

TAIPEI, June 25, 2012 /PRNewswire-Asia/ -- TaiGen Biotechnology Company, Limited ("TaiGen") and Zhejiang Medicine Company, Limited ("ZMC") today announced that they have signed an exclusive agreement to manufacture and commercialize nemonoxacin, a novel broad-spectrum antibiotic, in China (excluding Hong Kong, and Macau). Nemonoxacin is a novel broad-spectrum non-fluorinated quinolone antibiotic under development for respiratory infections. TaiGen will be responsible for completing the Phase 3 clinical trial for community acquired pneumonia ("CAP") in China. ZMC will be responsible for manufacturing, sales and marketing of nemonoxacin in China through its wholly-owned subsidiary, XinChang Pharmaceuticals. TaiGen will retain full development and commercialization rights outside the licensed territory including Taiwan, the United States, European Union, and Japan. Under the terms of the agreement, TaiGen will receive an upfront payment of US$ 8 million from ZMC and will receive additional milestones as well as royalties on product sales. The term of the agreement is 20 years.

Nemonoxacin has demonstrated efficacy and safety in CAP and diabetic foot infection in multinational and multi-center clinical trials conducted by TaiGen. In particular, nemonoxacin has excellent activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA. Nemonoxacin is taken once-a-day and available in both oral and intravenous formulations. Currently, TaiGen is completing a Phase 3 CAP trial with more than 500 patients from Taiwan and mainland China and expects to file new drug applications in Taiwan and mainland China simultaneously in early 2013.

China is one of the major antibiotic markets in the world. According to IMS, the sales of antibiotics in 2011 were approximately US$ 11 billion (RMB 68 billion) and account for almost 20% of the total pharmaceuticals sales. Rate of antibiotic resistant infections in China is among the highest in the world.

Mr. Li Chun Bo, Chairman of the ZMC, commented, "We are impressed with nemonoxacin's broad spectrum activity towards drug-resistant bacteria, in particular, MRSA, and excellent safety profile. We are excited to establish this partnership with TaiGen because of its reputation as a premier research-based biotech company in Asia. This partnership will break new ground for cross-strait collaboration in the pharmaceutical industry. Nemonoxacin will be a major addition to ZMC's antibiotic product line and significant profit driver".

Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, "China is the world's fastest growing pharmaceutical market. It is poised to overtake Japan as the second largest pharmaceutical market. We are extremely please to establish our nemonoxacin partnership with ZMC, a first-class pharmaceutical company and major player in the Chinese antibiotics market. With nemonoxacin, TaiGen and ZMC together will bring new medicine to treat unmet medical needs in China. This partnership will not only set a new record for pharmaceutical licensing involving a Taiwanese and a mainland Chinese company but hopefully will also become a model of the future collaborations," Dr. Hsu also added, "With the conclusion of the partnership in China, we will actively pursue nemonoxacin licensing discussions in other territories such as European Union."

About Zhejiang Medicine

Zhejiang Medicine Company, Limited is a leading pharmaceutical company in China specializing in sales and distribution of pharmaceuticals and manufacturing of active pharmaceutical ingredients (vitamins and antibiotics). Its sales revenue in 2011 is US $740 million (RMB 4.8 billion). ZMC is a leader in the Chinese antibiotic market with levofloxacin, vancomycin, and teicoplanin in the product line. ZMC's Lai Li Xin, a branded levofloxacin, is one of the top selling antibiotics in China with 2011 sales exceeding US $110 million (RMB 735 million). In addition to pharmaceuticals sales, ZMC is also known for its manufacturing quality. Its vancomycin active pharmaceutical ingredient has obtained GMP qualification from US Food and Drug Administration (FDA) and exported to western countries. ZMC is publicly listed in the Shanghai Stock Exchange (600216) and has a market capitalization of RMB 11 billion.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, mainland China. TaiGen has full discovery research capacity in Taiwan and clinical development in mainland China/Taiwan/US. In addition to nemonoxacin, TaiGen has two other in-house discovered new chemical entities in clinical development under IND with US FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 1. Both TG-0054 and TG-2349 are currently in clinical development in the US.

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TaiGen Biotechnology Out-Licensed China Rights of Novel Antibiotic, Nemonoxacin, to Zhejiang Medicine

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/skdhnn/translational_rege) has announced the addition of the "Translational Regenerative Medicine - Oncology, CNS and Cardiovascular-Rich Pipeline Features Innovative Stem Cell and Gene Therapy Applications" report to their offering.

More Guidelines Needed to Grow Regenerative Medicine Market, Report Finds

Standardized research guidelines are needed to control and encourage the development of gene therapy and stem cell treatments, according to a new report by healthcare experts GBI Research.

The new report* shows how regenerative medicine is seen as an area with high future potential, as countries need ways to cope with the burden of an aging population.

The stem cell market alone is predicted to grow to around $5.1 billion by 2014, while gene therapy has also shown promise despite poor understanding of some areas of regenerative medicine and a lack of major approvals (the only approvals to date being made in Asia).

Up until now, securing research within clinics has been difficult, with a high number of failures and discontinuations throughout all phases of clinical study. Stem cell therapy uses bone marrow transplants as an established treatment method, but the development of the therapy into further applications and has not yet become common practice.

Similarly, tissue engineering has been successful in the areas of skin and bone grafts, but translation into more complex therapies has been an issue for researchers. Although scientific possibilities are ever-increasing, the true potential of regenerative medicine has yet to be demonstrated fully.

A desire to discover new and innovative technologies has encouraged governments in the UK and Singapore to focus directly on regenerative medicine as a future potential economy booster.

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Research and Markets: Translational Regenerative Medicine - Oncology, CNS and Cardiovascular-Rich Pipeline Features ...

Reported in CELL, Stony Brook pathologist uncovers new p53 mechanism triggering necrosis

Newswise STONY BROOK, N.Y., June 22, 2012 The gene p53 is the most commonly mutated gene in cancer. p53 is dubbed the guardian of the genome because it blocks cells with damaged DNA from propagating and eventually becoming cancerous. However, new research led by Ute M. Moll, M.D., Professor of Pathology at Stony Brook University School of Medicine, and colleagues, uncovers a novel role for p53 beyond cancer in the development of ischemic stroke. The research team identified an unexpected critical function of p53 in activating necrosis, an irreversible form of tissue death, triggered during oxidative stress and ischemia. The findings are detailed online in Cell.

Ischemia-associated oxidative damage leads to irreversible necrosis which is a major cause of catastrophic tissue loss. Elucidating its signaling mechanism is of paramount importance. p53 is a central cellular stress sensor that responds to multiple insults including oxidative stress and is known to orchestrate apoptotic and autophagic types of cell death. However, it was previously unknown whether p53 can also activate oxidative stress-induced necrosis, a regulated form of cell death that depends on the mitochondrial permeability transition pore (PTP) pore.

We identified an unexpected and critical function of p53 in activating necrosis: In response to oxidative stress in normal healthy cells, p53 accumulates in the mitochondrial matrix and triggers the opening of the PTP pore at the inner mitochondrial membrane, leading to collapse of the electrochemical gradient and cell necrosis, explains Dr. Moll.

"p53 acts via physical interaction with the critical PTP regulator Cyclophylin D (CypD). This p53 action occurs in cultured cells and in ischemic stroke in mice."

Of note, they found in their model that when the destructive p53-CypD complex is blocked from forming by using Cyclosporine-A type inhibitors, the brain tissue is strongly protected from necrosis and stroke is prevented.

The findings fundamentally expand our understanding of p53-mediated cell death networks, says Dr. Moll. The data also suggest that acute temporary blockade of the destructive p53-CypD complex with clinically well-tolerated Cyclosporine A-type inhibitors may lead to a therapeutic strategy to limit the extent of an ischemic stroke in patients.

p53 is one of the most important genes in cancer and by far the most studied, says Yusuf A. Hannun, M.D., Director of the Stony Brook University Cancer Center, Vice Dean for Cancer Medicine, and the Joel Kenny Professor of Medicine at Stony Brook. Therefore, this discovery by Dr. Moll and her colleagues in defining the mechanism of a new p53 function and its importance in necrotic injury and stoke is truly spectacular.

Dr. Moll has studied p53 for 20 years in her Stony Brook laboratory. Her research has led to numerous discoveries about the function of p53 and two related genes. For example, previous to this latest finding regarding p53 and stroke, Dr. Moll identified that p73, a cousin to p53, steps in as a tumor suppressor gene when p53 is lost and can stabilize the genome. She found that p73 plays a major developmental role in maintaining the neural stem cell pool during brain formation and adult learning. Her work also helped to identify that another p53 cousin, called p63, has a critical surveillance function in the male germ line and likely contributed to the evolution of humans and great apes, enabling their long reproductive periods.

Dr. Molls Cell study coauthors include: Angelina V. Vaseva and Natalie D. Marchenko, Department of Pathology, Stony Brook University School of Medicine; Kyungmin Ji and Stella E. Tsirka, Department of Pharmacological Sciences, Stony Brook University School of Medicine; and Sonja Holzmann, Department of Molecular Oncology, University of Gottingen in Germany.

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Study Shows Most Commonly Mutated Gene in Cancer may have a Role in Stroke

Public release date: 22-Jun-2012 [ | E-mail | Share ]

Contact: William Gilroy gilroy.6@nd.edu 574-631-4127 University of Notre Dame

Alumnus Michael Gallagher and his wife, Elizabeth, have made a $5 million gift to establish the Elizabeth and Michael Gallagher Family Professorships in Adult Stem Cell Research at the University of Notre Dame.

Their gift, which will fund three new endowed professorships in adult and all forms of non-embryonic stem cell research, will strengthen Notre Dame's leadership in the field of stem cell research and enhance the University's effective dialogue between the biomedical research community and the Catholic Church on matters related to the use and application of stem cells and regenerative medicine.

"As a Catholic university, Notre Dame carries a mantle of responsibility to use our scholarship and resources to help alleviate human suffering, and, in this area of research in particular, to do so with deep respect for the sanctity of all human life," said Rev. John I. Jenkins, C.S.C., the University's president. "These new professorships will enable us to effectively build upon an already strong foundation in this critically important field. We are tremendously grateful to the Gallaghers for making this possible with their transformative gift."

Despite years of research, there are no known cures for a large number of degenerative diseases, such as Type 1 diabetes, Parkinson's disease, cardiovascular disease, macular degeneration and spinal cord injuries. Stem cell research has the potential to contribute to the discovery of new and successful treatments for these and other diseases because it holds the unique promise of regenerating damaged cells and tissues, fully restoring tissues and organs to their normal function.

Although this vital area of research could accelerate the ability to alleviate much human suffering, it has generated extensive ethical debate with the use of embryonic versus non-embryonic stem cells. The Catholic Church affirms the dignity of all human life at every stage and vigorously opposes the destruction of human embryos for the harvesting of stem cells. At the same time, the Church strongly endorses the use of adult and non-embryonic stem cell research as a potential therapy for individuals suffering from these debilitating diseases. Research has demonstrated that adult stem cells, including all forms of non-embryonic stem cells, such as induced pluripotent stem cells and umbilical cord stem cells, can be harvested and programmed to achieve pluripotency the same characteristic that enables embryonic stem cells to differentiate into any type of cell.

An urgent need exists to increase the number of faculty experts performing adult stem cell research at Notre Dame. Doing so will expand upon the strong foundation the College of Science holds in these areas and will help create an environment for excellence in which faculty and students can learn, grow, collaborate and ultimately affect human health.

"We are overwhelmed with gratitude at the generous gift from Mike and Liz Gallagher," said Gregory P. Crawford, dean of the College of Science. "The impact of this gift is truly beyond measure. It will play a crucial role in attracting three more of the best faculty in the field of adult stem cell research to Notre Dame. Furthermore, this gift will equip our existing talented group of adult stem cell researchers at Notre Dame to take the next great leap toward ultimately forming a premier center in adult stem cell research."

Michael Gallagher is a 1991 graduate of Notre Dame, and his wife, Elizabeth, is a 1992 graduate of Saint Mary's College. They have two sons, Brock and Jack, and currently live near Denver.

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Notre Dame establishes professorships in adult stem cell research

SAN BRUNO, Calif., June 20, 2012 /PRNewswire/ -- Twenty years ago this month, CBR (Cord Blood Registry) in partnership with the University of Arizona, processed the first cord blood stem cell sample in the world to be stored specifically for family use. Since 1992, the number of conditions treated with cord blood stem cells has greatly expanded, and so has CBR. Today, CBR is the largest family cord blood bank in the world with more than 425,000 samples in storage a population the size of a major city like Miami. What distinguishes the "city of individuals" with newborn stem cells banked at CBR is the exclusive opportunity to participate in a growing number of ground-breaking clinical trials.

(Photo: http://photos.prnewswire.com/prnh/20120620/SF27549-INFO)

(Logo: http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO)

"As the leader and innovator in family banking, we believe every newborn deserves a healthy future and that we have a responsibility to lead the way," said Heather Brown, vice president of scientific & medical affairs at CBR. "Looking back, the creation of our bank allowed families for the first time to preserve a genetically-related source of newborn stem cells, ready and available if needed for a lifesaving transplant to regenerate a person's immune system after radiation or chemotherapy. As we look to the future, we are helping shape new areas of regenerative medicine. We are the only family bank actively pioneering clinical trials evaluating new therapeutic uses of cord blood stem cells for unexpected injuries and conditions with no current cure."

Expanding Areas of Clinical Research: Helping the Body Heal Injured Nerves Until very recently, the prevailing medical opinion in neurology has been that damage to the central nervous system caused by injuries like birth trauma, accidents or stroke is often permanent. Currently, intervention after injury focuses on stabilizing the patient to minimize damage. However, data from animal research in recent years has challenged this assumption, leading to cord blood stem cell clinical research to study whether these cells may stimulate neural cell and tissue repair to restore function and alleviate neurological impairments.

CBR is taking the lead in moving animal research rapidly into the clinic to investigate the ability for cord blood stem cells to trigger the body's own mechanisms to initiate nerve repair by establishing specific clinical trials at leading medical institutions across the country. By pairing researchers with children who have been diagnosed with chronic conditions like cerebral palsy, traumatic brain injury or hearing loss-- and who also have access to their own cord blood stem cells -- CBR is helping physicians move beyond surgery and drugs to evaluate how newborn stem cells may help the body repair itself.

Celebrating a History of Firsts Throughout its history, CBR has taken many of the first steps to create and advance the notion of preserving and ensuring access to high quality newborn stem cells that are viable for use. Among the company's contributions to stem cell medicine and science, CBR was:

"CBR continuously improves our systems and technology to maintain the highest published cell recovery rate in the industry of 99%, every single time. We treat every sample as if it belongs to our own child or grandchild," says Tom Moore, CEO and founder of CBR. "That care and precision is what we offer clinical researchers, who are partnering exclusively with CBR to evaluate the use of a child's own cord blood stem cells to help treat chronic diseases like cerebral palsy, hearing loss and traumatic brain injury."

About Cord Blood RegistryCBR (Cord Blood Registry) is the world's largest and most experienced cord blood bank.The company has consistently led the industry in technical innovations and safeguards more than 425,000 cord blood collections for individuals and their families. CBR was the first family bank accredited by AABB and the company's quality standards have been recognized through ISO 9001:2008 certificationthe global business standard for quality. CBR has also released more client cord blood units for specific therapeutic use than any other family cord blood bank. Our research and development efforts are focused on helping the world's leading clinical researchers advance regenerative medical therapies.For more information, visit http://www.cordblood.com.

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CBR - World's Largest Stem Cell Bank - Applies Two Decades of Experience to Advance Regenerative Medicine

RIO DE JANEIRO--(BUSINESS WIRE)--

Cryopraxis established in 2001 as the pioneer private umbilical cord blood bank in Brazil will be present at Bio 2012 in Boston. Eduardo Cruz, chairman of the board, will be a speaker at the Brazilian break-out session speaking about The Brazilian Biotechnology Sector and showing the results of the company's commitment to R&D. Cryopraxis has already collected and processed more than 25000 cord blood units (CBU) and is actively involved in several R&D projects in Brazil and abroad.

A spin-off of Cryopraxis, Cellpraxis, has recently finished one of the world's first cell therapy project clinical trials in Brazil: ReACT. ReACT is a stem cell formulation. This regenerative medicine pioneer product aims on treating an orphan disease condition called refractory angina. Refractory angina patients suffer from untreatable severe chest pain and the results of the clinical trial in a 5 years follow up proved ReACT to positively interfere in the course of the pathology. Most of the individuals treated experienced relief in pain and better quality of life. ReACT will be presented at Bio2012 as an example of Brazil's dynamic biotechnology research.

Cryopraxis is accredited by the American Association of Blood Bank since 2009.

According to Tatiana Lima, Technical Director at Cryopraxis, "extensive training and strict adherence to good laboratory practices are basic principles in Cryopraxis' corporate strategy." Janaina Machado, cell lab director describes the company's primary mission: "maximizing safety and efficiency of collection procedures to make sure our clients get what they look for: the highest quality standards."

Cryopraxis is part of Axis Biotec (www.axisbiotec.com.br) and it has the largest biological cryogenic storage facility in Brazil and one of the largest in the World. It is the largest umbilical cord blood bank in Brazil. The company is involved in several research projects in Brazil and abroad.For more information, visitwww.cryopraxis.com.brand http://www.cellpraxis.com

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Cryopraxis, Sponsor of Stem Cell Research is Represented at Bio2012 in Boston

ScienceDaily (June 18, 2012) Chicagoan Ieshea Thomas is the first Midwest patient to receive a successful stem cell transplant to cure her sickle cell disease without chemotherapy in preparation for the transplant.

University of Illinois Hospital & Health Sciences System physicians performed the procedure using medication to suppress her immune system and one small dose of total body radiation right before the transplant.

The transplant technique is relatively uncommon and is a much more tolerable treatment for patients with aggressive sickle cell disease who often have underlying organ disease and other complications, says Dr. Damiano Rondelli, professor of medicine at UIC, who performed Thomas's transplant.

The procedure initially allows a patient's own bone marrow to coexist with that of the donor. Since the patient's bone marrow is not completely destroyed by chemotherapy or radiation prior to transplant, part of the immune defense survives, lessening the risk of infection. The goal is for the transplanted stem cells to gradually take over the bone marrow's role to produce red blood cells -- normal, healthy ones.

Thomas, 33, had her first sickle cell crisis when she was just 8 months old. Her disease became progressively worse as an adult, particularly after the birth of her daughter. She has spent most of her adult life in and out of hospitals with severe pain and has relied on repeated red blood cell transfusions. Her sickle cell disease also caused bone damage requiring two hip replacements.

"I just want to be at home with my daughter every day and every night," said Thomas, who depends on family to help care for her daughter during her frequent hospitalizations.

This type of stem cell transplant is only possible for patients who have a healthy sibling who is a compatible donor.

Thomas' sister was a match and agreed to donate blood stem cells through a process called leukapheresis. Several days prior to leukapheresis, Thomas' sister was given drugs to increase the number of stem cells released into the bloodstream. Her blood was then processed through a machine that collects white cells, including stem cells. The stem cells were frozen until the transplant.

Last Nov. 23, four bags of frozen stem cells were delivered to the hospital's blood and marrow transplant unit. One by one, the bags were thawed and hung on an IV pole for infusion into Thomas. The procedure took approximately one hour. Her 13-year-old daughter, Miayatha, was at her bedside.

Six months after the transplant, Thomas is cured of sickle cell disease and no longer requires blood transfusions.

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Chicago woman cured of sickle cell disease

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

* European Parliament debating funding for 2014 to 2020

* Scientists fear cuts to embryonic stem cell research

* Experts say cutting funds would hold back entire field

LONDON, June 15 (Reuters) - Leading scientists, biomedical research bodies and patient groups urged the European Parliament on Friday to maintain vital European Union funding for studies using embryonic stem cells.

Hailing the field as "one of the most exciting and promising" in modern biomedical research, the group said they feared research grants currently under review may be under threat from pro-life European parliamentarians who say public funds should not be spent on embryonic stem cell work.

"(EU) Commission funding must be available to continue to support scientists investigating all types of stem cells - including human embryonic stem cells - with potential to make advances in regenerative medicine," they wrote in an open letter released by the Wellcome Trust, a charitable health foundation.

The European Parliament is currently debating the future outline of Horizon (Euronext: HOR.NX - news) 2020, the EU's programme for research and innovation which will run from 2014 to 2020.

Draft rules provide for stem cell research funding, including embryonic stem cells but some member states have been lobbying for embryonic stem cell research to be excluded.

Many scientists believe stem cell research has the potential to lead to the development of treatments for a whole host of diseases including incurable neurodegenerative illnesses such as Parkinson's, motor neurone disease and multiple sclerosis, as well as type 1 diabetes, various serious heart conditions, liver damage, spinal cord damage and blindness.

Europe (Chicago Options: ^REURUSD - news) , and particularly Britain, is considered a world leader in stem cell research. The experts, from charities, funding bodies and patient groups, said if Europe is to hold on to this competitive edge, it is crucial to maintain funding for all stem cell research.

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Researchers urge EU not to cut stem cell funding

ScienceDaily (June 14, 2012) Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the U.S. National Institutes of Health's registry, making the cells available for federally-funded research.

U-M now has a total of eight cell lines on the registry, including five that carry genetic mutations for serious diseases such as the severe bleeding disorder hemophilia B, the fatal brain disorder Huntington's disease and the heart condition called hypertrophic cardiomyopathy, which causes sudden death in athletes and others.

Researchers at U-M and around the country can now begin using the stem cell lines to study the origins of these diseases and potential treatments. Two of the cell lines are believed to be the first in the world bearing that particular disease gene.

The three U-M stem cell lines now in the registry that do not carry disease genes are also useful for general studies and as comparisons for stem cells with disease genes. In all, there are 163 stem cell lines in the federal registry, most of them without major disease genes.

Each of the lines was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. The embryos carrying disease genes were created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation and would have otherwise been discarded if not donated by the couples who donated them.

Some came from couples having fertility treatment at U-M's Center for Reproductive Medicine, others from as far away as Portland, OR. Some were never frozen, which may mean that the stem cells will have unique characteristics and utilities.

The full list of U-M-derived stem cell lines accepted to the NIH registry includes:

"Our last three years of work have really begun to pay off, paving the way for scientists worldwide to make novel discoveries that will benefit human health in the near future," says Gary Smith, Ph.D., who derived the lines and also is co-director of the U-M Consortium for Stem Cell Therapies, part of the A. Alfred Taubman Medical Research Institute.

"Each cell line accepted to the registry demonstrates our attention to details of proper oversight, consenting, and following of NIH guidelines," says Sue O'Shea, Ph.D., professor of Cell and Developmental Biology at the U-M Medical School, and co-director of the Consortium for Stem Cell Therapies.

U-M is one of only three academic institutions to have disease-specific stem cell lines listed in the national registry, says Smith, who is a professor in the Department of Obstetrics and Gynecology at the University of Michigan Medical School. The first line, a genetically normal one, was accepted to the registry in February.

Continued here:
Six new stem cell lines now publicly available

ANN ARBOR Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the National Institutes of Healths registry, making the cells available for federally funded research.

UM now has a total of eight cell lines on the registry, including five that carry genetic mutations for serious diseases such as the severe bleeding disorder hemophilia B, the fatal brain disorder Huntingtons disease and the heart condition called hypertrophic cardiomyopathy, which causes sudden death in athletes and others.

Researchers at UM and around the country can now begin using the stem cell lines to study the origins of these diseases and potential treatments. Two of the cell lines are believed to be the first in the world bearing that particular disease gene.

The three UM stem cell lines now in the registry that do not carry disease genes are also useful for general studies and as comparisons for stem cells with disease genes. In all, there are 163 stem cell lines in the federal registry, most of them without major disease genes.

Each of the lines was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. The embryos carrying disease genes were created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation and would have otherwise been discarded if not donated by the couples who donated them.

Some came from couples having fertility treatment at UMs Center for Reproductive Medicine, others from as far away as Portland, Ore. Some were never frozen, which may mean that the stem cells will have unique characteristics and utilities.

The full list of UM-derived stem cell lines accepted to the NIH registry includes:

UM9-1PGD Hemophilia B

UM17-1PGD Huntingtons disease

UM38-2PGD- HypertrophicCardiomyopathy (MYBPC3)

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Six New UM Stem Cell Lines Now Publicly Available

Six new U-M stem cell lines now publicly available to help researchers find treatments for disease

Lines in US registry will help studies on Huntingtons disease, hemophilia & more

Newswise ANN ARBOR, Mich. Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the U.S. National Institutes of Healths registry, making the cells available for federally-funded research.

U-M now has a total of eight cell lines on the registry, including five that carry genetic mutations for serious diseases such as the severe bleeding disorder hemophilia B, the fatal brain disorder Huntingtons disease and the heart condition called hypertrophic cardiomyopathy, which causes sudden death in athletes and others.

Researchers at U-M and around the country can now begin using the stem cell lines to study the origins of these diseases and potential treatments. Two of the cell lines are believed to be the first in the world bearing that particular disease gene.

The three U-M stem cell lines now in the registry that do not carry disease genes are also useful for general studies and as comparisons for stem cells with disease genes. In all, there are 163 stem cell lines in the federal registry, most of them without major disease genes.

Each of the lines was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. The embryos carrying disease genes were created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation and would have otherwise been discarded if not donated by the couples who donated them.

Some came from couples having fertility treatment at U-Ms Center for Reproductive Medicine, others from as far away as Portland, OR. Some were never frozen, which may mean that the stem cells will have unique characteristics and utilities.

The full list of U-M-derived stem cell lines accepted to the NIH registry includes:

UM9-1PGD Hemophilia B UM17-1 PGD Huntingtons disease UM38-2 PGD - Hypertrophic Cardiomyopathy (MYBPC3) UM15-4 PGD - Hydroxysteroid Dehydrogenase 4 Deficiency, a rare hormone disorder UM11-1PGD - Charcot-Marie-Tooth disease Type 1A UM4-6 no disease gene UM14-1 no disease gene UM14-2 no disease gene

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Six New U-M Stem Cell Lines Now Publicly Available

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19. The presentations will cover the companys three ongoing clinical trials using human embryonic stem cell-derived retinal pigment epithelial cells to treat macular degeneration, and other programs.

Gary Rabin, chairman and CEO, will present at the 2012 Bio International Convention on Tuesday, June 19 at 8:15 a.m. EDT, at the Boston Convention & Exhibition Center.

Matthew Vincent, Ph.D., director of business development, will present at the Clinical Outlooks for Regenerative Medicine meeting at 9:15 a.m. EDT on the same date, at the Starr Center, Schepens Eye Research Institute, at 185 Cambridge Street in Boston.

Both presentation slide decks will be available on the conference presentations section of the ACT website.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

Continued here:
Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for ...

June 14, 2012, SEATTLE /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that former OncoMed Pharmaceuticals executive, Steven E. Benner, M.D., M.H.S., has joined CTI as Executive Vice President and Chief Medical Officer ("CMO"), reporting to James A. Bianco, M.D., Chief Executive Officer. Dr. Benner will take over all drug development activities at the company.Dr. Benner was previously senior vice president and chief medical officer at OncoMed, a venture-backed biotechnology company focused on the development of cancer stem cell targeting agents. Prior to OncoMed, he was CMO at Protein Design Labs ("PDL"), where he was accountable for all development activities including clinical development, clinical operations, biometry, regulatory affairs, and safety. He also served as Chair of the Portfolio and Clinical Development Management Committees of PDL. Before PDL he held several senior executive roles at Bristol-Myers Squibb in global development, life cycle management, and licensing and alliances.

"Dr. Benner brings to CTI his proven track record of success in advancing the development of innovative therapies for cancer patients," said Dr. Bianco. "His appointment is the first step in re-aligning our portfolio efforts, as we focus on advancing pacritinib into Phase III pivotal studies later this year."

With the new company initiative of the planned Pixuvri launch in Europe later this year, Jack W. Singer, M.D., will assume the newly-created role of Executive Vice President ("EVP") of Global Medical Affairs and Translational Medicine, responsible for cancer drug development strategy, global medical affairs, and life cycle management.

"Given Jack's impressive academic credentials, the respect he receives from an international network of key opinion leaders in the field, and his track record in oncology drug development, this was a natural promotion as we introduce Pixuvri in Europe," said Dr. Bianco.

"CTI has assembled an impressive late-stage portfolio of novel targeted therapies that address a spectrum of blood related cancers," said Dr. Benner. "With two drugs in Phase III and two more expected to enter Phase III trials within a year, this is an exciting and transformational time to join the team at CTI."

About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.

In May 2012 Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/communityregister/html/h764.htm#ProcList.

Pixuvri is currently available in the EU through Named Patient Programs.

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessmentthat address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

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Cell Therapeutics Appoints New Chief Medical Officer

This is a human ES cell-derived optic cup generated in our self-organization culture (culture day 26). Bright green, neural retina; off green, pigment epithelium; blue, nuclei; red, active myosin (strong in the inner surface of pigment epithelium). Credit: Nakano et al. Cell Stem Cell Volume 10 Issue 6

Human-derived stem cells can spontaneously form the tissue that develops into the part of the eye that allows us to see, according to a study published by Cell Press in the 5th anniversary issue of the journal Cell Stem Cell. Transplantation of this 3D tissue in the future could help patients with visual impairments see clearly.

"This is an important milestone for a new generation of regenerative medicine," says senior study author Yoshiki Sasai of the RIKEN Center for Developmental Biology. "Our approach opens a new avenue to the use of human stem cell-derived complex tissues for therapy, as well as for other medical studies related to pathogenesis and drug discovery."

During development, light-sensitive tissue lining the back of the eye, called the retina, forms from a structure known as the optic cup. In the new study, this structure spontaneously emerged from human embryonic stem cells (hESCs)cells derived from human embryos that are capable of developing into a variety of tissuesthanks to the cell culture methods optimized by Sasai and his team.

The hESC-derived cells formed the correct 3D shape and the two layers of the optic cup, including a layer containing a large number of light-responsive cells called photoreceptors. Because retinal degeneration primarily results from damage to these cells, the hESC-derived tissue could be ideal transplantation material.

Beyond the clinical implications, the study will likely accelerate the acquisition of knowledge in the field of developmental biology. For instance, the hESC-derived optic cup is much larger than the optic cup that Sasai and collaborators previously derived from mouse embryonic stem cells, suggesting that these cells contain innate species-specific instructions for building this eye structure. "This study opens the door to understanding human-specific aspects of eye development that researchers were not able to investigate before," Sasai says.

The anniversary issue containing Sasai's study will be given to each delegate attending the 2012 ISSCR meeting in Yokohama, Japan. To highlight the ISSCR meeting and showcase the strong advances made by Japanese scientists in the stem cell field, the issue will also feature two other papers from Japanese authors, including the research groups of Akira Onishi and Jun Yamashita. In addition, the issue contains a series of reviews and perspectives from worldwide leaders in stem cell research.

More information: Nakano et al.: "Self-Formation of Optic Cups and Storable Stratified Neural Retina from Human ESCs." DOI 10.1016/j.stem.2012.05.009

Journal reference: Cell Stem Cell

Provided by Cell Press

Original post:
Scientists see new hope for restoring vision with stem cell help

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed

LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models.

"The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies."

Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials.

Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments.

"The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues," adds Jyothikumar. "As a result, market prices for various products may be affected."

Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

"In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies," cautions Jyothikumar. "Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics."

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New Applications in Drug Discovery Platforms to Fuel Advance of Stem Cells, Says Frost & Sullivan

13 June 2012 Last updated at 08:31 ET

Japanese stem cell scientist Dr Shinya Yamanaka has been awarded the Millennium Technology Prize.

His award is for discovering how to reprogram human cells to mimic embryonic stem cells, which can become any cell in the body.

Called induced pluripotent stem (iPS) cells, these now aid research into regenerative medicine.

He was joint-winner with Linus Torvalds, who created a new open source operating system for computers.

This is the first time the prize has been shared by two scientists - they will split the 1.2m euros ($1.3m; 800,000) award.

My goals over the decade include to develop new drugs to treat intractable diseases by using iPS cell technology and to conduct clinical trials using it on a few patients with Parkinson's diseases, diabetes or blood diseases.

The President of the Republic of Finland, Sauli Niinisto, presented the prize at the Finnish National Opera in Helsinki.

Dr Ainomija Haarla, President of Technology Academy Finland - the foundation which awards the prize every two years - said: "The International Selection Committee has to judge whether an innovation has had a favourable impact on people's lives and assess its potential for further development to benefit humanity in the future.

"The innovations of both this year's winners embody that principle.

Excerpt from:
Stem cell scientist wins award

A few years ago, concerns over these heart trials were voiced by a Norwegian professor, Harald Arnesen. He concluded in 2007 that they are not convincing and that one German team had achieved striking results only because the control group in its trial had done particularly badly. Prof Arnesen called for a moratorium on this kind of stem-cell therapy.

That still did not deter the clinicians. This January, another trial funded by the EU was announced the largest of all, with 3,000 heart-attack patients recruited from across Europe.

The idea behind the trials is straightforward. During a heart attack, a clogged blood vessel starves heart muscle of oxygen. Up to a billion heart muscle cells, called cardiomyocytes, can be damaged, and the body responds by replacing them with relatively inflexible scar tissue, which can lead to fatal heart failure. So why not implant stem cells that can grow into cardiomyocytes?

Stem cells, of course, come in many kinds: the embryonic variety have the potential to turn into all 200 cell types in the body. Adult stem cells, harvested from the patient, have a more limited repertoire: bone marrow stem cells generate blood cells, for example. So to claim, as was done in 2001, these bone marrow stem cells could turn into heart muscle was both surprising and exciting.

Analysis shows that, at best, the amount of blood pumped during a contraction of one heart chamber rose by 5 per cent after treatment. In a patient where heart efficiency has fallen to 30 per cent of normal, that could be significant but it is relatively meagre, none the less. And it turns out that this level of improvement results whatever the cells injected into the damaged muscle even if they have no prospect of forming cardiomyoctes.

Even the believers in the technique now agree that implanted cells exert a paracrine action, triggering a helpful inflammatory response or secreting chemicals that boost blood vessel formation. But were still waiting for convincing evidence that a patients lost heart muscle cells can be replaced.

Embryonic stem cells offer one route to that goal, though it is difficult to turn them into the right cell type reliably, and there are other risks, such as uncontrolled growths. Another option has come from work by Prof Richard Lee at the Harvard Stem Cell Institute, who has found that some adult stem cells can recruit other stem cells already in the heart to become cardiomyocytes.

Meanwhile, other fields of medicine that have seen more systematic research on stem cells are making real progress in using them for example, to treat Parkinsons, diabetes and macular degeneration. The lesson here is that, ultimately, it takes careful experiments, not belief, to make that huge leap from the laboratory to the hospital.

Roger Highfield is director of external affairs at the Science Museum Group

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Heart disease and stem-cell treatments: caught in a clinical stampede