SAN DIEGO CA--(Marketwire -06/29/12)- Medistem Inc. (MEDS) announced today notice of allowance from the United States Patent and Trademark Office (USPTO) for a patent covering the use of fat stem cells, and cells associated with fat stem cells for treatment of diseases related to a dysfunctional immune system. Such diseases include multiple sclerosis, Type 1 diabetes, rheumatoid arthritis and lupus. The allowed patent, entitled "Stem Cell Mediated Treg Activation/Expansion for Therapeutic Immune Modulation" has the earliest priority date of December 2006.

"We have previously published that giving multiple sclerosis patients cells extracted from their own fat tissue, which contains stem cells, appears to confer clinical benefit in a pilot study," said Thomas Ichim, CEO of Medistem. "The current patent that has been allowed, in the broadest interpretation of the claims, gives us exclusive rights to the use of specific types of fat stem cell therapy for autoimmune diseases such as multiple sclerosis."

Subsequent to the filing of the patent application, Medistem together with collaborators at the Lawson Health Sciences Research Institute, Canada, reported data that fat tissue contains high numbers of T regulatory cells, a type of immune cell that is capable of controlling autoimmunity.

This finding was independently confirmed by Dr. Diane Mathis' laboratory at Harvard University, who published a paper in the prestigious journal, Nature Medicine, in which detailed experimental evidence was provided supporting the initial finding that adipose tissue contains high numbers of T regulatory cells. A video describing the paper can be accessed at http://www.youtube.com/watch?v=rEJfGu29Rg8.

The current patent discloses the use of T regulatory cells from fat, combinations with stem cells, and use of fat-derived mononuclear cells. Given that there are currently several groups utilizing this technology in the USA in treating patients, Medistem believes revenue can be generated through enforcement of patent rights.

"Our corporate philosophy has been to remain highly focused on our ongoing clinical stage programs using Medistem's universal donor stem cell, the Endometrial Regenerative Cell (ERC), in the treatment of critical limb ischemia and congestive heart failure," said Dr. Vladimir Bogin, Chairman and President of Medistem. "However, due to the ease of implementation of our fat stem cell technology, combined with the major burden that autoimmune diseases have on our health care system, we are highly incentivized to explore partnering, co-development and licensing opportunities."

Autoimmune conditions occur as a result of the body's immune system "turning on itself" and attacking its own organs or cells. Current treatments for autoimmune conditions are based on "globally" suppressing the immune system by administration of immunosuppressive drugs. This is associated with an increased predisposition to infections and significant side effects. The utilization of stem cells and T regulatory cells offers the potential to selectively suppress pathological immunity while preserving the ability of the body to fight bacteria and viruses. According to the NIH there are approximately 23 million victims of autoimmune conditions.

Links to Documents:

Link to peer-reviewed publication: http://www.translational-medicine.com/content/pdf/1479-5876-7-29.pdf

Link: http://www.marketwire.com/press-release/medistem-files-patent-application-on-therapeutic-cell-population-found-in-fat-tissue-frankfurt-s2u-812298.htm

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Medistem Receives Notice of Patent Allowance Covering Fat Stem Cell Therapy of Autoimmune Diseases

Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells.

The study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet."

The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation.

According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track their fate in vivo. This was accomplished by visualization with MRI.

"We found a good correlation between MRI non-invasive follow-up of the injected cells and immunofluoresence or quantitative PCR data," said Dr. Menasche. The researchers concluded that further studies were needed to follow cell homing at later time points. They noted that the magnitude of homing they experienced may have been reduced by the relatively small number of cells used, owing to their large size and the subsequent risk of coronary thrombosis.

"In a rat model of myocardial infarction, this pilot study suggested homing of circulating stem cells can be improved by magnetic targeting and warrants additional benchwork to confirm the validity of concept," said Dr. Menasche. "There is also a need to optimize the parameters of targeting and assess the relevance of this approach in a clinically relevant large animal model."

"This study highlights the use of magnets to target transplanted cells to specific sites which could increase their regenerative impact. Factors to still be extensively tested include confirming the safety of the cells containing the magnetic particles and whether this process alters the cell's abilities" said Dr. Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

More information: Chaudeurge, A.; Wilhelm, C.; Chen-Tournoux, A.; Farahmand, P.; Bellamy, V.; Autret, G.; Mnager, C.; Hagge, A.; Larghro, J.; Gazeau, F.; Clment, O.; Menasch, P. Can Magnetic Targeting of Magnetically Labeled Circulating Cells Optimize Intramyocardial Cell Retention? Cell Transplant. 21 (4):679-691; 2012.

Journal reference: Cell Transplantation

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Magnet helps target transplanted iron-loaded cells to key areas of heart

25-06-2012 00:49 ProGenaCell physicians provide advanced cellular therapy to patients suffering from all known degenerative diseases. For over 70 years cell therapy has been used safely and effectively in such diverse regions as the European Union, former USSR, Republic of China, Middle East, Pacific Rim, Central and South America, Baja California and more recently the United States under select clinical trials. ProGenaCell provides patients with autologous stem cells (patient's own cells), adult progenitor xenocells, and organ extracts & growth factors. These "cellular products" are delivered to physicians who have been approved to prescribe and administer cellular therapies to patients in need. All cellular products are lawfully manufactured, and regulated under strict European Union guidelines. Visit us:

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Dr. Ulrich Friedrichson, MD,PHD - Cell Therapy Introduction - Video

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

NEW YORK, June 25, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a cell therapy company, today announced that it has been awarded a two year grant totaling $595,252 for the "Development of Human, Autologous, Pluripotent Very Small Embryonic Like (VSELs) Stem Cells as a Countermeasure to Radiation Threat" from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This peer reviewed grant was awarded to support research to be headed by Denis O. Rodgerson, Ph.D., Director of Stem Cell Science for NeoStem and Mariusz Ratajczak, M.D., Ph.D., who is the head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at the University of Louisville and co-inventor of VSELTM Technology.

This award will fund studies to investigate the potential of very small embryonic-like stem cells as a countermeasure to radiological and nuclear threat. The product candidate, which is an autologous stem cell therapy derived from the patient's own stem cells, will be developed to rescue patients who have been exposed to radiation due to nuclear accident or terrorist threat and to treat cancer patients who have undergone radiation therapy and who consequently have compromised immune systems. The award includes $295,252 for the first year and $300,000 for the second year of the project.

Dr. Denis O. Rodgerson, Director of Stem Cell Science for NeoStem, said, "We are very excited to add radiation treatment to the growing list of indications for which our VSELTM Technology is being evaluated. Those exposed to acute high-dose radiation have compromised immune systems such that the virulence and infectivity of biological agents is dramatically increased. Death can occur within 1-6 weeks following radiation exposure. Currently there is only one intervention that saves a fatally irradiated person -- a rescue through stem cell transplantation. VSELs might be an ideal cell therapy to regenerate the body's immune system and repair other tissues damaged by radiation exposure. Most importantly, early studies show VSELs are resistant to lethal radiation which destroys other immune system restoring stem cells in the body, making autologous treatment post-exposure possible."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, added, "NeoStem is pleased that the NIAID is funding this cutting edge technology that we hope will reinvent the treatment landscape for acute radiation syndrome. We plan to continue to pursue NIH SBIR grants to fund our VSEL technology platform development with non-dilutive capital."

About VSELTM Technology

NeoStem has a worldwide exclusive license to VSELTM Technology. Research by Dr. Mariusz Ratajczak, M.D., Ph.D., and others at the University of Louisville provides compelling evidence that bone marrow contains a heterogeneous population of stem cells that have properties similar to those of an embryonic stem cell. These cells are referred to as very small embryonic-like stem cells. This finding opens the possibility of capturing some of the key advantages associated with embryonic stem cells without the ethical or moral dilemmas and without some of the potential negative biological effects associated with stem cells of embryonic derivation. The possibility of autologous VSEL treatments is yet another important potential benefit to this unique population of adult stem cells. VSELTM Technology offers the potential to go beyond the paracrine effect, yielding cells that actually differentiate into the target tissue creating true cellular regeneration.

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements

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NeoStem Awarded NIAID Research Grant for the Development of VSEL Technology for Radiation Exposure

Referenced Stocks: ILMN, LIFE, TMO

Given the recent flurry of activities, it seems that Life Technologies Corporation ( LIFE ) is focused on strengthening its foothold in the field of stem cell research. The company recently signed a non-exclusive agreement with iPS Academia of Japan for its induced pluripotent stem (iPS) cell patent portfolio. Based on this agreement, the company will be able to expand its portfolio for the iPS cell research community.

Besides, it is well placed to create iPS cells and differentiate them into various cell types to be used in drug discovery and pre-clinical research. The license also enables Life Technologies to provide creation, differentiation and screening services of iPS cell to scientists globally. We consider the agreement to be a significant achievement for the company in the field of stem cell research as iPS cells are gaining attention for use in the areas of drug discovery, disease research and other areas of biotechnology.

The agreement with iPS Academia of Japan comes on the heels of the partnership with Cellular Dynamics International, the world's largest producer of human cells derived from iPS cells. The partnership will aim at commercializing a set of three new products optimized to consistently develop and grow human iPS cells for both research and bioproduction.

These initiatives undertaken by Life Technologies should strengthen its Research Consumables segment. This segment includes molecular and cell biology reagents, endpoint PCR and other benchtop instruments and consumables. These products include RNAi, DNA synthesis, sample prep, transfection, cloning and protein expression profiling and protein analysis, cell culture media used in research, stem cells and related tools, cellular imaging products, antibodies and cell therapy related products. In the most recent quarter, this division recorded a 4% year-over-year increase in revenues to $420 million on the back of growth in cell culture workflow products, endpoint PCR products and molecular and cell biology consumables.

Life Technologies enjoys a strong position in the life sciences market, though management prefers to maintain a cautious but optimistic outlook for the remainder of the year. We are encouraged by the improvement in margins amidst the tight competitive scenario with the presence of players such as Thermo Fisher Scientific ( TMO ), Illumina ( ILMN ), among others.

We have a Neutral recommendation on Life Technologies. The stock retains a Zacks #3 Rank (hold) in the short term.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

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LIFE Focuses on Stem Cell Research - Analyst Blog

A new camera system allows researchers to measure multiple cardiac signals at once to understand how they interact to control heart function.

THE DEVICE: A complex interplay of signals governs the hearts rhythm. Voltage changes and calcium flux are both important in controlling heart muscle function, with each signal influencing the others dynamics. Scientists at the University of Oxford have created a single camera system that can capture the dynamics of these signals simultaneously, yielding important insight into their relationship.

Peter Lee and colleagues combined several colors of light emitting diodes (LEDs) with a multi-band emission filter so that one very high speed camera could capture the different wavelengths of light emitted by various fluorescent dyes. By using different colors of LEDs, they were able to stimulate different dyes to measure changes in calcium and voltage across cardiac tissue or single layers of human cardiomyocytes (created from induced pluripotent stem cells).

WHATS NEW:The new setup took advantage of advances in lighting technology, explained Lee. While many older systems used xenon lamps, LEDs are cheap, cover the spectrum from infrared to ultraviolet, and reach peak intensity almost immediatelyallowing for ultra-rapid switching between excitation colors. Many previous systems also relied on a moving wheel to switch between colors, and thus measure different signals, explained Guy Salama, who researches cardiac arrhythmias at the University of Pittsburgh, but was not involved in the new cameras development. The wheels needed to move uniformly without wobbling, which would throw off its precision measurements, said Salama, and meant that each parameter had to be recorded for exactly the same amount of time. But Lees system, which uses electronics to control the length of time each LED shines, allows for different excitation times for each parameter of interestwhich is important as not all physiological changes happen on the same time scale, said Salama. Lees system has also jettisoned the need for moving parts, which can require careful alignment.

Single camera and LED system. Peter Lee

IMPORTANCE: Because calcium and voltage changes interact to control cardiac function, and perturbations in either leading to dysfunctions like arrhythmia, Lees camera system provides researchers with a tool to further investigate the interaction between the two signals, and thus gain a deeper understanding of cardiac function.

Using a single camera with multiple emission filters also allowed Lee and his collaborators to measure calcium properly, Lee explained. Many previous experiments used high-affinity calcium dyes, which bound strongly but could perturb the signal. The strong LEDs allowed for weaker-binding dyes, and ratiometric calcium measurement, meaning the dyes display shifts in emission wavelength upon binding calcium. Researchers can then quantify the concentration of calcium based on the light emissions they detect and calcium flux simultaneously.

Additionally, explained Lee, the simplicity of the system makes it more easily scalable. LEDs are cheap and perform well, and the lack of moving parts makes setup much easier than multi-camera systems that need careful calibration.

NEEDS IMPROVEMENT: As appealingly simple as a one-camera setup is, a single camera and multiple light sources can also introduce new hurdles, explained Salama. Because one camera is being used to capture multiple parameters, this cuts down on the number of image frames that can be devoted to each signal, noted Salama. For example, if a camera is running at 1,000 frames per second, but imaging four signals, only 250 of those frames would capture each parameter.

Salama also feared that lining up the LEDs and camera might result in the different light sources hitting the cardiac tissue at different angles, and bouncing off at different angles, making it difficult for the camera to capture them all. When visualizing the voltage and calcium propagations over a single layer of cells, scientists need to make sure the emissions theyre comparing are coming from the same locationso they arent trying to match voltage changes in one set of cells with calcium fluxes in another. When imaging microscopic-scale changes, Lee works around this problem by merging the lights into one path and using an optical fiber to direct all the colors to one site.

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Next Generation: The Heart Camera

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.

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Six new stem cell lines now publicly available

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), announced today it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. With this decision New Zealand joins Canada, which last month became the worlds first internationally recognized regulatory authority to grant approval to a stem cell drug. Prochymal is also the first therapy approved for GvHD - a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. I would like to thank the professionals at Medsafe for their thoughtful and expeditious review of this complex application. I would also like to thank the team at Osiris that continues to do an outstanding job of making Prochymal available to children around the world suffering from the devastating effects of GvHD."

Osiris submitted a New Medicine Application (NMA) to Medsafe(New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981.

"The incidence of GvHD is likely to rise as the demographic profile of our transplant population evolves," said Hans Klingemann, M.D., Ph.D., a Professor of Medicine and the Director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine. "Effective strategies to manage the often lethal consequences of GvHD reduce the overall risk to transplantation and provide the transplant physician with better options when approaching their most difficult cases.

Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64 percent of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival.

As a mother who watched my son Christian suffer and die from the horrifying effects of GvHD, while waiting for the regulatory approvals necessary to allow him access to Prochymal, words cannot express how happy I am that significant progress is finally being made, said Sandy Barker, President and Co-founder of the Gold Rush Cure Foundation. We are proud to stand side-by-side with Osiris in this historic battle for our children around the world. Our motto is 'not one more child, not one more family' and when it comes to GvHD mortality, zero is the only acceptable number.

Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). It is expected that Prochymal will be commercially available in New Zealand later this year.

About GvHD

GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.

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Osiris Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent by New Zealand

Salk researcher's findings suggest a potentially favorable time to harvest stem cells for therapy and may reveal genes crucial to tissue production

LA JOLLA, CA----With their potential to treat a wide range of diseases and uncover fundamental processes that lead to those diseases, embryonic stem (ES) cells hold great promise for biomedical science. A number of hurdles, both scientific and non-scientific, however, have precluded scientists from reaching the holy grail of using these special cells to treat heart disease, diabetes, Alzheimer's and other diseases.

In a paper published June 13 in Nature, scientists at the Salk Institute for Biological Studies report discovering that ES cells cycle in and out of a "magical state" in the early stages of embryo development, during which a battery of genes essential for cell potency (the ability of a generic cell to differentiate, or develop, into a cell with specialized functions) is activated. This unique condition, called totipotency, gives ES cells their unique ability to turn into any cell type in the body, thus making them attractive therapeutic targets.

"These findings," says senior author Samuel L. Pfaff, a professor in Salk's Gene Expression Laboratory, "give new insight into the network of genes important to the developmental potential of cells. We've identified a mechanism that resets embryonic stem cells to a more youthful state, where they are more plastic and therefore potentially more useful in therapeutics against disease, injury and aging."

ES cells are like silly putty that can be induced, under the right circumstances, to become specialized cells-for example, skin cells or pancreatic cells-in the body. In the initial stages of development, when an embryo contains as few as five to eight cells, the stem cells are totipotent and can develop into any cell type. After three to five days, the embryo develops into a ball of cells called a blastocyst. At this stage, the stem cells are pluripotent, meaning they can develop into almost any cell type. In order for cells to differentiate, specific genes within the cells must be turned on.

Pfaff and his colleagues performed RNA sequencing (a new technology derived from genome-sequencing to monitor what genes are active) on immature mouse egg cells, called oocytes, and two-cell-stage embryos to identify genes that are turned on just prior to and immediately following fertilization. Pfaff's team discovered a sequence of genes tied to this privileged state of totipotency and noticed that the genes were activated by retroviruses adjacent to the stem cells.

Nearly 8 percent of the human genome is made up of ancient relics of viral infections that occurred in our ancestors, which have been passed from generation to generation but are unable to produce infections. Pfaff and his collaborators found that cells have used some of these viruses as a tool to regulate the on-off switches for their own genes. "Evolution has said, 'We'll make lemonade out of lemons, and use these viruses to our advantage,'" Pfaff says. Using the remains of ancient viruses to turn on hundreds of genes at a specific moment of time in early embryo development gives cells the ability to turn into any type of tissue in the body.

From their observations, the Salk scientists say these viruses are very tightly controlled-they don't know why-and active only during a short window during embryonic development. The researchers identified ES cells in early embryogenesis and then further developed the embryos and cultured them in a laboratory dish. They found that a rare group of special ES cells activated the viral genes, distinguishing them from other ES cells in the dish. By using the retroviruses to their advantage, Pfaff says, these rare cells reverted to a more plastic, youthful state and thus had greater developmental potential.

Pfaff's team also discovered that nearly all ES cells cycle in and out of this privileged form, a feature of ES cells that has been underappreciated by the scientific community, says first author Todd S. Macfarlan, a former postdoctoral researcher in Pfaff's lab who recently accepted a faculty position at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. "If this cycle is prevented from happening," he says, "the full range of cell potential seems to be limited."

It is too early to tell if this "magical state" is an opportune time to harvest ES cells for therapeutic purposes. But, Pfaff adds, by forcing cells into this privileged status, scientists might be able to identify genes to assist in expanding the types of tissue that can be produced.

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"Magical State" of Embryonic Stem Cells May Help Overcome Hurdles to Therapeutics

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

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Scientists see new hope for restoring vision with stem cell help

June 12, 2012

The use of stem-cells building-block cells that are harvested from embryos or adults to treat heart disease could rely on faith as much as it does science, after billions of dollars in research has not produced the results that researchers have been looking for.

Questions and concerns on the topic arose during the recent opening of the multi-million-dollar Scottish Center for Regenerative Medicine (SCRM) in Edinburgh, chaired by Sir Ian Wilmut, the renowned scientist whose Dolly the sheep clone in 1996, was a groundbreaking step in stem cell technology.

During the opening ceremonies of the Center, Christine Mummery of the Leiden University Medical Center in the Netherlands discussed how a 2001 claim, based on mice experimentation, indicated that bone-marrow cells could mend heart damaged by coronary disease, caused a mad rush of people to the clinics looking for a cure-all.

With nothing in the way of systematic research in animals, the first patients were being treated within a year, prematurely by Mummerys account. She argued that the paper that launched the mass stampede was completely wrong, and subsequent studies proved that. But despite the findings, the 2001 paper has never been withdrawn.

Norwegian professor Harald Arnesen in 2007 voiced his concerns over those heart trials as well. He concluded that they were not convincing and that one German team had achieved striking results only because the control group had done particularly badly. Arnesen called for a moratorium on this kind of stem-cell therapy, based on that research.

But neither Arnesen, nor Mummery, could deter clinicians. Another trial, the largest to date, began in January 2012 and included 3,000 heart-attack patients recruited from across Europe. The trial was funded by the European Union as well.

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.

What is notably surprising, explained Mummery, is that stem cells come in many different forms: Embryonic stem cells are the building-blocks of the body and have the potential to turn into all 200 cell types found in the human body. Adult stem cells, however, are limited in what they can do. For example, bone marrow stem cells only generate blood cells.

So, the 2001 study claiming that bone marrow stem cells could turn into healthy heart muscle was a surprising and exciting claim, although a bold move.

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Some Stem-Cells May Not Be The Answer For Heart Disease

By Jacque Wilson, CNN

updated 1:44 PM EDT, Tue June 12, 2012

2009: Robin Roberts on her cancer

STORY HIGHLIGHTS

(CNN) -- Robin Roberts' battle against myelodysplastic syndrome, or MDS, is just beginning. The "Good Morning America" anchor will undergo chemotherapy before having a bone marrow transplant later this year.

"Bone marrow donors are scarce and particularly for African-American women," Roberts wrote Monday. "I am very fortunate to have a sister who is an excellent match, and this greatly improves my chances for a cure."

More than 10,000 people in the United States are diagnosed with blood-related disorders every year, according to the National Marrow Donor Program. Often the best treatment is a bone marrow transplant. During the procedure, a donor's stem cells are directly transfused into the sick patient's bloodstream. The patient's new cells multiply over time to create healthy bone marrow.

Unfortunately, the chance of finding a match on the national registry is as low as 66% for African-Americans and other minorities, compared with 93% for Caucasians.

Be the Match, the national registry, has 10 million potential donors, but only 7% are African-American. While the percentage is comparable to the overall African-American population in the United States (which is 12%), the registry is meeting only about a third of the needs for African-American transplants, said Dr. Jeffrey Chell, CEO of the National Marrow Donor Program.

Tuskegee's ghosts: Fear hinders black marrow donation

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Roberts found match; many not as lucky

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/pqrlwc/analysis_of_the_st) has announced the addition of Frost & Sullivan's new report "Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics" to their offering.

This Frost & Sullivan research service titled Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics focuses on prospects for the stem cell therapeutics market in Europe and provides valuable recommendations and conclusions for market participants. Market segmentation is based on regulatory framework in Europe relating to research on adult and embryonic stem cells. The main countries discussed are the United Kingdom, Germany, France, Spain, Sweden, Finland, and the remaining parts of Europe.

Market Overview

New Applications in Drug Discovery Platforms to Drive Stem Cells Market

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. 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 the analyst of this research. 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.

Host of Challenges Need to be Confronted before Stem Cell Therapeutics can Realise its Potential

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 the analyst. 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 the analyst. Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics. To push through policy or regulatory reforms, the technology platform and geographical location of stem cell companies should complement the terms laid down in EMEA. The methodology for cell expansion and synchronisation must be optimised to acquire a large population of the desired cell at the right differentiation point, adds the analyst. More research is needed in human pluripotent and multi potent stem cell as it differs from mice to humans. Completion of clinical trials will be essential to ensure the safety and efficacy of the stem cell therapy.

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Research and Markets: Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics

Public release date: 11-Jun-2012 [ | E-mail | Share ]

Contact: Susan Martonik smartonik@snm.org 703-652-6773 Society of Nuclear Medicine

Miami Beach, Fla.Finding a way to restore hair growth after substantial hair loss is something of an obsession worldwide. Investigators at the Society of Nuclear Medicine's 2012 Annual Meeting presented how stem cell research for the development of new hair follicles can be monitored with an optical imaging technique that uses bioluminescence, the same process that allows fireflies to light up.

There is a host of treatments available for hair loss, including creams and drugs, but these have not shown to be very effective for hair growth. Hair stem cells signal the actual regeneration of hair follicles and natural hair. A molecular imaging technique called bioluminescence is used to display processes at the cellular level. Bioluminescent signal is generated in specific chemical substances called substrates. These signals are easily recognized with very sensitive optical imaging systems that can see what is happening in the smallest placesin this case in hair stem cells.

"Hair regeneration using hair stem cells is a promising therapeutic option emerging for hair loss, and molecular imaging can speed up the development of this therapy," saysByeong-Cheol Ahn, M.D., Ph.D., professor and director of the department of nuclear medicine at Kyungpook National University School of Medicine and Hospital in Daegu, South Korea. "This study is the first study of hair follicle regeneration using an in vivo molecular imaging technique."

The current research involves grafting hair stem cells in animal models to investigate if they can grow and proliferate as normal cells do. The progress of hair stem cell therapy is non-invasivelytracked with bioluminescentreporter genes in specialized substrates. There are several bioluminescent reporter genes originating fromnot only fireflies, but also beetles, glowworms and other bioluminescent organisms. The strategy of using bioluminescent reporter genesis ideal for stem cell research, because bioluminescence works only in living cells.

In this study, researchers used bioluminescence imaging usingfirefly luciferase coupled with D-luciferin to monitor the engraftment of hair follicle stem cellscalled newborn fibroblastsin mice to track their viability and development into hair folliclesover time. Bioluminescence imaging was performed five times over the course of 21 days after transplantation of the stem cells.

Results of the study showed successful bioluminescence imaging forhair regeneration with hair stem cell transplantation, and new hair follicles were apparent on the surface of skin samples under microscope. More studies will have to be conducted before clinical trials could be initiated to verify whether this therapy would work for human hair regeneration.

###

Scientific Paper 74: Jung Eun Kim, Byeong-Cheol Ahn, Ho Won Lee, Mi-hye Hwang, Sang-Woo Lee and Jaetae Lee, Nuclear Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea; Seng Hyun Shin and Young Kwan Sung, Immunology, Kyungpook National University School of Medicine, Daegu, Republic of Korea, "In vivo monitoring of survival and proliferation of hair stem cells in hair follicle regeneration animal model," SNM's 59th Annual Meeting, June 9, 2012, Miami Beach, Fla.

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Bioluminescence imaging lights up stem cell therapy for hair growth

Scientists have paved the way for human bones to be replaced with new ones grown outside the body. Photo: iStockphoto

SCIENTISTS have grown human bone from stem cells in a laboratory, paving the way for patients to have broken bones repaired - or even replaced with new ones grown outside the body from their own cells.

Researchers started with stem cells taken from fat tissue. It took about a month to grow them into sections of fully formed living bone up to several centimetres long.

The first trial in patients is on course for later this year, by an Israeli biotechnology company that has been working with academics on the technology.

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Professor Avinoam Kadouri, head of the scientific advisory board for Bonus BioGroup, said: ''We use three-dimensional structures to fabricate the bone in the right shape and geometry. We can grow these bones outside the body and then transplant them to the patient.

''By scanning the damaged bone area, the implant should fit perfectly and merge with the surrounding tissue. There are no rejection problems as the cells come from the patient.''

The technology, developed with researchers at the Technion Institute of Research in Israel, uses three-dimensional scans of damaged bone to build a gel-like scaffold that matches the shape.

Stem cells, known as mesenchymal stem cells, that have the capacity to develop into many other types of body cell, are taken from a patient by liposuction and are then grown into living bone inside a ''bioreactor'' - a machine that provides the conditions to encourage the cells to develop into bone.

Animals have already successfully received bone transplants, but in the latest study, the scientists were able to insert almost 2.5 centimetres of laboratory-grown human bone into a rat's leg bone, where it successfully merged with the remaining animal bone.

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Fixing broken bones a growth industry

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Stem cell therapy offers new treatment options for pets -- and humans

News | Mind & Brain

A unique form of carbon dating, made possible by the Cold War, suggests that new neurons rarely survive in the human olfactory bulb after birth

By Ferris Jabr | June 7, 2012

BOMBSHELL FINDINGS: A new study relying on radioactive carbon from Cold War nuclear tests argues that the adult human brain rarely weaves new neurons into the olfactory bulb, but not everyone is convinced. Image: Adapted from Wikimedia Commons images

In this groundbreaking adventure into the worlds of psychopaths, the renowned psychologist Kevin Dutton argues that there is a fine line between a brilliant...

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The human body is a tireless gardener, growing new cells throughout life in many organsin the skin, blood, bones and intestines. Until the 1980s most scientists thought that brain cells were the exception: the neurons you are born with are the neurons you have for life. In the past three decades, however, researchers have discovered hints that the human brain produces new neurons after birth in two places: the hippocampusa region important for memoryand the walls of fluid-filled cavities called ventricles, from which stem cells migrate to the olfactory bulb, a knob of brain tissue behind the eyes that processes smell. Studies have clearly demonstrated that such migration happens in mice long after birth and that human infants generate new neurons. But the evidence that similar neurogenesis persists in the adult human brain is mixed and highly contested.

A new study relying on a unique form of carbon dating suggests that neurons born during adulthood rarely if ever weave themselves into the olfactory bulb's circuitry. In other words, peopleunlike other mammalsdo not replenish their olfactory bulb neurons, which might be explained by how little most of us rely on our sense of smell. Although the new research casts doubt on the renewal of olfactory bulb neurons in the adult human brain, many neuroscientists are far from ready to end the debate.

In preparation for the new study, Olaf Bergmann and Jonas Frisn of the Karolinska Institute in Stockholm and their colleagues acquired 14 frozen olfactory bulbs from autopsies performed between 2005 and 2011 at the institute's Department of Forensic Medicine. To determine whether the neurons were younger than the people they came fromwhich would mean the cells were generated after birththe researchers needed to isolate the cells' DNA. First, they dissolved the brain tissue into a kind of soup, which they spun at high speeds so that the dense cell bodies and nuclei containing DNA sank to the bottom of the flasks. Using Y-shaped proteins called antibodies, which were hitched to fluorescent markers, the researchers tagged nuclei from both neurons and from glia, non-neuronal brain cells. After a laser-equipped cell-sorting machine identified and separated the nuclei, the researchers isolated and purified the DNA within.

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How Nuclear Fallout Casts Doubt on Renewal of Some Adult Brain Cells

06-06-2012 13:09 Mesenchymal stem cell homing to tissue damage, umbilical cord stem cells historically used for anti-aging, mesenchymal stem cells role in immune system modulation, inflammation reduction and stimulating tissue regeneration, donor stem cell safety and testing, the role of HLA matching in donated umbilical cord-derived stem cells, umbilical cord blood safety data and historical use in blood transfusions, allogeneic stem cell persistence in human mothers. Treatment information at More information on Dr. Riordan at

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Neil Riordan PhD - Stem Cell Therapy for Spinal Cord Injury (Part 3 of 5) || Stem Cell Treatments - Video

It's always troubling to see a misunderstanding concerning a recent scientific discovery. The latest concerns an Israeli team of scientists, led by Lior Gepstein, that converted skin cells from two patients with heart attack into stem cells and then heart cells.

SourceFed, one of my favorite channels on YouTube, proclaimed that Gepstein's study means that a cure for heart disease is "10, 15 years out." Similar statements were also circulated by The Guardian, The Los Angeles Times, CBS News, and others.

However, the claims that SourceFed and other news outlets have made are not true. If anything, the field of heart regeneration is moving away from what the study did. If there is a cure for heart attack in 10 to 15 years, it will not be because of this study.

Generating stem cells from skin cells is relatively old news. This feat was first performed in 2006 for mice (2007 for humans) concurrently by two teams of scientists led by Shinya Yamanaka in Japan and James Thomson in the United States, respectively. Since then, the technology has evolved so fast that generating heart cells from stem cells is truly nothing new.

Stem cells often differentiate into heart cells, or cardiomyocytes, without much technical intervention. Even I, a mere undergraduate student, have generated beating heart cells several times without much trouble, from mice and rat skin cells. And I'm not even in the field of heart regeneration. I work with stem cells in neurobiology.

The technique to generate heart cells from skin-derived stem cells (or induced pluripotent stem cells) has existed for a long time. After a brief search on Google Scholar, I found a paper published in 2008 detailing how to generate heart cells from skin cells. This may not seem like a long time ago, but in the stem-cell world, that's almost an eon.

So if we have been able to generate heart cells for such a long time, why has no one actually successfully transplanted heart cells into patients? One of the reasons is that there are so many different problems with not only transplanting heart cells onto a beating heart but also with the induced pluripotent stem cells that are derived from skin cells.

When a heart is damaged, scar tissues grow over the damaged part of the heart. The scar tissue does not function like regular heart cells. Instead of beating, the scar tissue just sits there, not doing anything and getting in the way of the beating heart. It's just like a scab on your arm from a scrape. The only difference is that the scab eventually comes off, because your skin is constantly making new cells, but the scar on your heart doesn't, because heart cells rarely regenerate, if at all.

Transplanting new heart cells without removing the scars is like putting a new layer of skin over the old scab and expecting the scab to go away. The old scab doesn't go away. More likely, the transplanted tissue will just die off.

As a result, instead of trying to transplant new tissue, the field of heart regeneration is now trying to transform the cells in scar tissue into beating heart cells. Though there are also problems with this new direction, it opens up ways of solving a whole host of other problems that plague heart-cell transplantation.

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Rui Dai: Our Misunderstanding of Stem Cells