StemCell Therapy

Figure 1: iPSCs cultivated atop a 'feeder' layer of mouse embryonic fibroblasts (top left) maintain expression of a fluorescent pluripotency marker (top right; green). However, these cells also thrive (bottom left) and maintain their pluripotency (bottom right) when grown on a glutaraldehyde-fixed feeder cell layer. Image reproduced under the terms of the CCAL, with copyright shared by Yue et al

Stem cells are renowned for their capacity to develop into a wide range of mature cell types but they cannot maintain this flexibility on their own. In the body, neighboring cells help maintain this pluripotent state. But to grow these cells in culture, scientists have had to devise a variety of specialized techniques.

This is especially true for embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs), which are ESC-like cells derived from adult tissue. To preserve their pluripotency, these cells have typically been grown atop a supporting layer of feeder cells. Now, a strategy developed by a team led by Yoshihiro Ito at the RIKEN Advanced Science Institute, Wako, promises to make ESC and iPSC cultivation considerably easier.

Feeder cells provide valuable growth factors for stem cells but also make culture complicated and create opportunities for contaminationan especially serious concern for clinical applications. Early attempts to isolate the key features of feeder cells have fallen short. It was difficult to culture stem cells on growth-factor immobilized substrates, says Ito. Feeder cells provide a complex microenvironment that cannot simply be replaced with one or several growth factors.

As an alternative, the researchers subjected feeder cell layers to chemical fixation treatments that killed the cells while physically preserving them and maintaining their external structure largely intact. This resulted in a robust cell culture surface that retained virtually all of the features with which stem cells would typically interact. Mouse iPSCs maintained their pluripotent state even after extensive cultivation on feeder cells that had previously been fixed with either formaldehyde (FA) or glutaraldehyde (GA). GA fixation is a harsher treatment, but Ito and colleagues noted that GA fixed cells also provided a superior substrate, and this GA-fixed layer was robust enough to be washed and reused.

The researchers were pleasantly surprised to find that mouse iPSCs grown in this manner were virtually indistinguishable from those cultured by traditional methods (Fig. 1). Feeder cells were believed to secrete proteins or other compounds that maintain the growth of undifferentiated stem cells, says Ito. But fixed cells lose this secretion capability, which shows that providing the right contact microenvironment is more important for iPSCs. Given how rugged the fixed cell layers are, he anticipates that this approach could offer a commercially viable cell culture tool once it has been tested and optimized for cultivation of human iPSCs.

More information: Yue, X.-S., Fujishiro, M., Nishioka, C., Arai, T., Takahashi, E., Gong, J.-S., Akaike, T. & Ito, Y. Feeder cells support the culture of induced pluripotent stem cells even after chemical fixation. PLoS ONE 7, e32707 (2012). http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0032707

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Stem cells thrive on superficial relationships

TUCSON, Ariz., Aug. 9, 2012 /PRNewswire/ -- Doctors at the University of Oklahoma reported the first successful procedure for growing new blood vessels from adipose, or 'fat derived,' stem cells. These newly formed blood vessels can be used in heart bypass surgery and other complicated procedures requiring healthy vessels, according to the researchers, who presented their findings at the American Heart Association's 2012 Scientific Sessions.

(Photo: http://photos.prnewswire.com/prnh/20120809/LA54820)

Through liposuction, doctors can collect hundreds of millions of stem cells that can be used to generate blood vessels. The cells were "seeded" onto a 'bio-scaffold' and as they multiplied, researchers rolled them into tubes with the diameter of small blood vessels. Within weeks, new, healthy tissue began to grow into usable blood vessels. And since the cells are 'autologous', or from the same patient, there is no risk of adverse reactions or rejection.

But one of the key considerations is the age of the patient and thus the age of the stem cells. Young stem cells are much more active and potent than older cells. And young blood vessels are much more functional than older vessels.

One potential downside is that these blood vessels take time to grow in the lab. "They would not be available immediately, but you could bank your own cells and keep them until the time comes that you need them," said Dr. Roberto Bolli, an American Heart Association spokesman and chief of cardiology at the University of Louisville in Kentucky.

Success using stem cells in tissue engineering have led to just that-the option for patients to bank their adipose stem cells as a biological resource for use in the future in tissue engineering and regenerative medicine.

Dr. David Harris, Professor of Immunology at the University of Arizona in Tucson, is Chief Scientific Officer and founder of Adicyte, an adipose stem cell cryogenic bank. AdiCyte uses modern cryopreservation methods to safely store an individual's adult adipose tissue and stem cells for their future use in regenerative medicine, tissue engineering and cosmetic or reconstructive procedures.

"Adipose tissue is the richest source of mesenchymal stem cells (MSCs) in the human body, and more than 100 FDA clinical trials are in motion to help bring these cellular therapies to approved indications" said Harris.

For $985, patients can save their adipose tissue and stem cells, and request them whenever needed. There is an annual maintenance fee of $120. Cryogenic storage of the tissue in essence, 'stops the clock' on cell aging, so if the cells are needed twenty years from now, they will still have the same level of vitality and activity as when they were banked.

"The ability for a patient and doctor to literally pre-order new blood vessels for a heart bypass patient is exactly what AdiCyte is about," says Scott Edelman, AdiCyte's CEO and co-founder. "We want to help drive the advancement of regenerative medicine by enabling people to preserve their youngest stem cells possible, so they have the opportunity to take advantage of these miraculous new technologies and live longer."

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Scientists have identified a type of stem cell that appears to be responsible for the neurons involved in higher brain function. The discovery may pave the way for new treatments for autism and schizophrenia.

The mammalian cerebral cortex is layered like an onion, with neurons in different layers responsible for different levels of cognitive function. Neurons in the inner layers are connected to subcortical targets such as the thalamus and basal ganglia that deal with basic sensory and motor signals. Neurons in the outer layers are connected to other parts of the cortex, which in humans play a role in higher-level brain processes such as self-awareness, language and problem-solving.

In the developing brain, stem cells in the heart of the cortex produce neurons in sequence from the inner layer outwards. "Neurons migrate past earlier-born neurons to reach a more superficial position," explains Ulrich Mueller at The Scripps Research Institute in California. This is then repeated to generate all cortical layers, with a neuron's birthdate determining its layer and therefore its function. "However, it had never been established whether the connection between birthdate and neuronal cell type is casual or causal," says Mueller. "We went to find out."

In the prevailing model, different types of neurons are generated in successive waves by a single type of stem cell. However, when Mueller and his colleagues studied the developing brains of mice embryos, they found that neurons in the upper layers of the cortex are produced by a different type of stem cell. This is particularly intriguing since upper layer neurons are especially abundant in humans. "Maybe the invention of this new type of stem cell was important in driving brain evolution," says Mueller.

Upper layer neurons are also frequently affected in psychiatric disorders such as schizophrenia and autism. "A better understanding of the development of these layers and their functions may help us to understand the causes of these mental disorders, which could lead to better treatments in the future," says Andre Strydom of University College London, who was not involved in the study. But he notes that any clinical application is probably a long way off.

Uta Frith, also of University College London, says the finding is fascinating but sounds a note of caution. "There is still a chasm between neuro-cognitive explanations of autistic symptoms and mechanisms in terms of cell structure," she says. "To put these two levels of explanation together is a big task."

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Stem cells responsible for higher brain function found

LEUVEN, BELGIUM and MADRID, SPAIN--(Marketwire -08/08/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders.

"In addition to the primary endpoints of safety and optimal dosing, we expect this trial to yield a first indication of the duration of the efficacy of Cx611 in this very difficult patient population: the enrolled patients have previously failed to respond to at least two biologicals," said Eduardo Bravo, CEO of TiGenix. "In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result. This is the most advanced stem cell therapy trial in RA in the world, and completing the enrollment on time confirms our leadership position in the field. We anticipate reporting the results of the study no later than April 2013."

About Cx611 for rheumatoid arthritisCx611 is a suspension of expanded allogeneic adult stem cells derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or 'eASCs') that is delivered through intra-venous injection for the treatment of rheumatoid arthritis. The objective of the Phase IIa trial is to determine safety, feasibility, tolerance, and optimal dosing. This multicentre, placebo-controlled study has enrolled 53 patients, divided in 3 cohorts with different dosing regimens. There are 23 centers open and the company expects the final results to be available in the first half of 2013.

About TiGenixTiGenix NV (EURONEXT:TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit http://www.tigenix.com.

Forward-looking informationThis document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

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TiGenix Completes Patient Enrollment in Phase IIa Rheumatoid Arthritis Study

ROCKVILLE, MD--(Marketwire -08/08/12)- MarketResearch.com has announced the addition of the new report "Global Markets for Stem Cells," to their collection of Biotechnology market reports. For more information, visit http://www.marketresearch.com/BCC-Research-v374/Global-Stem-Cells-7083022/

The global market for stem cell products was $3.8 billion in 2011. This market is expected to reach nearly $4.3 billion in 2012 and $6.6 billion by 2016, increasing at a compound annual growth rate (CAGR) of 11.7% from 2011 to 2016.

The American market for stem cell products was $1.3 billion in 2011. This sector is expected to rise at a CAGR of 11.5% and reach nearly $2.3 billion by 2016.

The European market for stem cell products was $872 million in 2011 and is expected to reach nearly $1.5 billion by 2016, a CAGR of 10.9%.

For more information, visit http://www.marketresearch.com/BCC-Research-v374/Global-Stem-Cells-7083022/

About MarketResearch.com

MarketResearch.com is the leading provider of global market intelligence products and services. With research reports from more than 720 top consulting and advisory firms, MarketResearch.com offers instant online access to the world's most extensive database of expert insights on global industries, companies, products, and trends. Moreover, MarketResearch.com's Research Specialists have in-depth knowledge of the publishers and the various types of reports in their respective industries and are ready to provide research assistance. For more information, call Will Gray at 240-747-3008 or visit http://www.marketresearch.com.

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Latest Research Shows Stem Cell Product Market to Reach $6 Billion by 2016

Originally published August 7, 2012 at 7:45 PM | Page modified August 7, 2012 at 8:25 PM

Two University of Washington scientists, using expertise in stem cells, cardiology, pathology, cell biology and the electrophysiology of the heart, are a step closer to their holy grail: regenerating a damaged heart.

Human heart-muscle cells injected into the damaged heart of a guinea pig not only strengthened the heart's ability to contract, the cells synchronized with the animal's heart and protected it from arrhythmias, rhythm disturbances that can be fatal.

Regenerating a damaged heart is the "big dream, the big vision," said Dr. Charles E. Murry, a cardiovascular biologist who co-led the research published in the most recent issue of Nature.

"This is the first demonstration that human heart-muscle grafts can electrically stabilize the injured heart, and the first demonstration that they can couple and beat in sync," Murry said.

When the researchers injected the human heart cells, grown from embryonic stem cells, into the hearts of guinea pigs with damaged hearts, they saw a "profound effect," said Dr. Michael Laflamme, the senior author.

"The animals that had received these stem-cell-derived heart-muscle cells had far fewer arrhythmias," said Laflamme.

Like Murry, he is a cardiovascular biologist, pathologist and member of the UW Center for Cardiovascular Biology and the Institute for Stem Cell and Regenerative Medicine.

To tell if the new cells were beating in rhythm with their host, the researchers inserted a sensor gene that would fluoresce green when the cells contracted. The fluorescent protein was originally discovered in the Aequorea victoria jellyfish at Friday Harbor on San Juan Island.

In the last several years, medical science has made much progress in helping patients survive acute heart attacks, Murry noted.

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UW researchers see work as step toward regenerating human heart

Regulated information August 8, 2012

TiGenix completes patient enrollment in Phase IIa rheumatoid arthritis study

Leuven (BELGIUM), Madrid (SPAIN) - August 8, 2012 - TiGenix (NYSE Euronext: TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company`s Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders.

"In addition to the primary endpoints of safety and optimal dosing, we expect this trial to yield a first indication of the duration of the efficacy of Cx611 in this very difficult patient population: the enrolled patients have previously failed to respond to at least two biologicals," said Eduardo Bravo, CEO of TiGenix. "In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result. This is the most advanced stem cell therapy trial in RA in the world, and completing the enrollment on time confirms our leadership position in the field. We anticipate reporting the results of the study no later than April 2013."

About Cx611 for rheumatoid arthritis Cx611 is a suspension of expanded allogeneic adult stem cells derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or `eASCs`) that is delivered through intra-venous injection for the treatment of rheumatoid arthritis. The objective of the Phase IIa trial is to determine safety, feasibility, tolerance, and optimal dosing. This multicentre, placebo-controlled study has enrolled 53 patients, divided in 3 cohorts with different dosing regimens. There are 23 centers open and the company expects the final results to be available in the first half of 2013.

For more information: Eduardo Bravo Chief Executive Officer eduardo.bravo@tigenix.com

Claudia D`Augusta Chief Financial Officer claudia.daugusta@tigenix.com Hans Herklots Director Investor & Media Relations hans.herklots@tigenix.com +32 16 39 60 97

About TiGenix

TiGenix NV (NYSE Euronext Brussels: TIG)is a leading European cell therapy companywith a marketed product for cartilage repair, ChondroCelect, and a strongpipeline with clinical stage allogeneic adult stem cell programsfor the treatment ofautoimmune and inflammatory diseases.TiGenixis based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (theNetherlands). For more information please visitwww.tigenix.com.

Forward-looking information

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TiGenix : completes patient enrollment in Phase IIa rheumatoid arthritis study

Cardiac muscle cells derived from human embryonic stem cells

The promise of embryonic stem cells lies in their ability to develop into any type of cell in the human body, which should allow us to replace tissues lost due to injury or disease. But it's one thing to generate replacement cells; it's another thing to generate entire tissues and integrate them into a functioning organ. A paper released by Nature now reports some success with turning human embryonic stem cells (hESCs) into cardiac cells and getting them to beat in synchrony with a damaged heart.

The blockage of blood vessels in the heart, either through clots or occlusion, causes the cells that rely on the blocked vessel to die off. This both weakens the heart structurally and changes the ability of the heart to beat in an organized manner, since the scar tissue that develops doesn't conduct electrical impulses. Serious arrhythmias can develop as a result of this changed activity, and these can sometimes end up causing the heartbeat to be lost entirely.

Embryonic stem cells have been used to try to repair damaged hearts for a while, starting with simple experiments where the stem cells themselves were injected. More recently, researchers have induced hESCs to form cardiac muscle cells (cardiomyocytes) before implanting them in a damaged heart (typically that of a mouse or rat). This treatment tends to increase the ability of the heart to pump blood, indicating that stem cells can reverse the weakening of the heart.

But it has been harder to get at the electrical integration of these stem cells, in part because the rodents that the researchers used have a very fast heartbeaton the order of 400-600 beats a minute. (The human heart rate is normally under 100 beats per minute.) So, the new work relied on the guinea pig, which apparently has a heart rate that is only about 200-250 beats per minute.

The authors took an hESC line and induced it to form cardiomyocytes, which were injected into injured hearts and then allowed to integrate with the injured heart for a while. Rather than focusing on blood flow, the authors tracked the development of arrhythmias. It turns out that the hESC-derived cardiomyocytes suppressed them. The guinea pigs treated with them had the lowest rate of premature ventricular contractions, or PVCs, which occur when the lower chambers of the heart beat ahead of schedule. They also went into tachycardia, or a run of rapid heartbeats, less often.

To track the behavior of the hESC-derived cardiac cells, the authors inserted a gene for a protein that becomes fluorescent in response to changes in calcium, which accompany the electrical impulses that drive a heartbeat. By tracking whether a cell was glowing, the authors could determine whether the human cells were tied to the regular guinea pig heartbeat.

Here, the results were a bit mixed. In areas where the hESC-derived cells were stuck in an area with lots of scar tissue, they tended to contract on their own, without significant influence from the guinea pig's rhythm. But in other areas where the cells were clear of nearby scar tissue, they tended to tie in nicely with the heart's overall rhythmeven when they weren't necessarily close to any guinea pig tissue.

The results are very promising, in that they show that embryonic stem cells can be used to create a large population of cardiomyocytes that can then function normally when placed back into a heart. But they also make it clear that scar tissue remains a problem in damaged hearts. Even if muscle tissue gets replaced, it won't integrate well if there's a significant amount of scar tissue around. This provides researchers with an obvious target for future efforts.

Incidentally, a number of the researchers involved in this work were based at US institutions. Early in the history of stem cell research, legislation was considered that would ban the creation of human-animal hybrids. Although it was probably written with Frankenstein-like chimeras in mind, some of it was so broadly worded that it would have banned basic safety and efficacy research such as the work described by this paper. Fortunately, it never passed, so US researchers are still able to contribute to work like this.

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Heart tissue derived from embryonic stem cells doesn't skip a beat

Shinya Yamanaka aims to produce cell lines from fetal blood cells.

M. Naka/Aflo/Newscom

Progress toward stem-cell therapies has been frustratingly slow, delayed by research challenges, ethical and legal barriers and corporate jitters. Now, stem-cell pioneer Shinya Yamanaka of Kyoto University in Japan plans to jump-start the field by building up a bank of stem cells for therapeutic use. The bank would store dozens of lines of induced pluripotent stem (iPS) cells, putting Japan in an unfamiliar position: at the forefront of efforts to introduce a pioneering biomedical technology.

A long-held dream of Yamanakas, the iPS Cell Stock project received a boost last month, when a Japanese health-ministry committee decided to allow the creation of cell lines from the thousands of samples of fetal umbilical-cord blood held around the country. Yamanakas plan to store the cells for use in medicine is a bold move, says George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts. But some researchers question whether iPS cells are ready for the clinic.

Yamanaka was the first researcher to show, in 2006, that mature mouse skin cells could be prodded into reverting to stem cells1 capable of forming all bodily tissues. The experiment, which he repeated2 with human cells in 2007, could bypass ethical issues associated with stem cells derived from embryos, and the cells could be tailor-made to match each patient, thereby avoiding rejection by the immune system.

Japan is pumping tens of millions of dollars every year into eight long-term projects to translate iPS cell therapies to the clinic, including a US$2.5-million-per-year effort to relieve Parkinsons disease at Kyoto Universitys Center for iPS Cell Research and Application (CiRA), which Yamanaka directs. That programme is at least three years away from clinical trials. The first human clinical trials using iPS cells, an effort to repair diseased retinas, are planned for next year at the RIKEN Center for Developmental Biology in Kobe.

Those trials will not use cells from Yamanakas Stock. But if they or any other iPS cell trials succeed, demand for the cells will explode, creating a supply challenge. Deriving and testing iPS cells tailored to individual patients could take six months for each cell line and cost tens of thousands of dollars.

Yamanakas plan is to create, by 2020, a standard array of 75 iPS cell lines that are a good enough match to be tolerated by 80% of the population. To do that, Yamanaka needs to find donors who have two identical copies of each of three key genes that code for immune-related cell-surface proteins called human leukocyte antigens (HLAs). He calculates that he will have to sift through samples from some 64,000 people to find 75 suitable donors.

Using blood from Japans eight cord-blood banks will make that easier. The banks hold some 29,000samples, all HLA-characterized, and Yamanaka is negotiating to gain access to those that prove unusable for other medical procedures. One issue remains unresolved: whether the banks need to seek further informed consent from donors, most of whom gave the blood under the understanding that it would be used for treating or studying leukaemia. Each bank will determine for itself whether further consent is needed.

Yamanaka has already built a cell-processing facility on the second floor of CiRA and is now applying for ethics approval from Kyoto University to create the stock. Takafumi Kimura, a CiRA biologist and head of the projects HLA analysis unit, says that the team hopes to derive the first line, carrying a set of HLA proteins that matches that of 8% of Japans population, by next March.

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Stem-cell pioneer banks on future therapies

CLEARWATER, FL--(Marketwire -08/07/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced the appointment of Marina Pizarro, M.D. to its Scientific and Medical Board of Advisors (SAMBA). Chief Executive Officer Dwight Brunoehler stated, "The addition of Dr. Pizarro to Scientific and Medical Board of Advisors rounds out our team with expertise in the field of hair re-growth using stem cells. We look forward to her interaction with the members to help advance the Company's mission to improve the quality and longevity of life for all mankind through the use of ethically sourced stem cells."

Dr. Pizarro is currently the Medical Director for Biostem U.S. as well as their trainer for the Company's hair re-growth Affiliate Program. As the company accepts qualified affiliate physicians to administer The Biostem Method of hair re-growth throughout the United States, Dr. Pizarro will oversee their training at her Orlando, Florida location, where she is currently accepting patients. Dr. Pizarro will begin offering the Biostem Method in her Tampa and Jacksonville, Florida offices in the coming months. She will also assist in overseeing the set-up of another training facility overseas as the company expands its Medical Affiliate Program internationally.

Dr. Marina Pizarro holds the distinction of being the first female hair transplant physician in the industry and belongs to the elite group of surgeons who have performed over 30,000 hair transplant procedures in their careers. She received her medical degree from Ponce School of Medicine in Puerto Rico in 1985. After completing her residency in Orlando, Dr. Pizarro worked with world renowned hair transplant surgeon Dr. Constantine Chambers building one of the largest hair restoration practices in history. After five years, and after having performed thousands of procedures around the world while lecturing at hair restoration conventions, Dr. Pizarro opened her first two facilities in Orlando and Jacksonville, Florida in 1994, specializing in hair transplantation for both men and women. She currently has three facilities in Florida with the addition of her clinic in Tampa. Dr. Pizarro is a member of The International Society of Hair Restoration Surgery and the European Society of Hair Restoration Surgery.

About Biostem U.S. Corporation

Biostem U.S., Corporation (HAIR) (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem U.S., Corporation Appoints Marina Pizarro, M.D. to Scientific and Medical Board of Advisors (SAMBA)

--Studies in mice reveal how mood-altering drugs may affect brain stem cells

Newswise Working with mice, Johns Hopkins researchers say they have figured out how stem cells found in a part of the brain responsible for learning, memory and mood regulation decide to remain dormant or create new brain cells. Apparently, the stem cells listen in on the chemical communication among nearby neurons to get an idea about what is stressing the system and when they need to act.

The researchers say understanding this process of chemical signaling may shed light on how the brain reacts to its environment and how current antidepressants work, because in animals these drugs have been shown to increase the number of brain cells. The findings are reported July 29 in the advance online publication of Nature.

What we learned is that brain stem cells dont communicate in the official way that neurons do, through synapses or by directly signaling each other, says Hongjun Song, Ph.D., professor of neurology and director of Johns Hopkins Medicines Institute for Cell Engineerings Stem Cell Program. Synapses, like cell phones, allow nerve cells to talk with each other. Stem cells dont have synapses, but our experiments show they indirectly hear the neurons talking to each other; its like listening to someone near you talking on a phone.

The indirect talk that the stem cells detect is comprised of chemical messaging fueled by the output of neurotransmitters that leak from neuronal synapses, the structures at the ends of brain cells that facilitate communication. These neurotransmitters, released from one neuron and detected by a another one, trigger receiving neurons to change their electrical charges, which either causes the neuron to fire off an electrical pulse propagating communication or to settle down, squelching further messages.

To find out which neurotransmitter brain stem cells can detect, the researchers took mouse brain tissue, attached electrodes to the stem cells and measured any change in electrical charge after the addition of certain neurotransmitters. When they treated the stem cells with the neurotransmitter GABA a known signal-inhibiting product the stem cells electrical charges changed, suggesting that the stem cells can detect GABA messages.

To find out what message GABA imparts to brain stem cells, the scientists used a genetic trick to remove the gene for the GABA receptor the protein on the surface of the cell that detects GABA only from the brain stem cells. Microscopic observation of brain stem cells lacking the GABA receptor over five days showed these cells replicated themselves, or produced glial cells support cells for the neurons in the brain. Brain stem cells with their GABA receptors intact appeared to stay the same, not making more cells.

Next, the team treated normal mice with valium, often used as an anti-anxiety drug and known to act like GABA by activating GABA receptors when it comes in contact with them. The scientists checked the mice on the second and seventh day of valium use and counted the number of brain stem cells in untreated mice and mice treated with the GABA activator. They found the treated mice had many more dormant stem cells than the untreated mice.

Traditionally GABA tells neurons to shut down and not continue to propagate a message to other neurons, says Song. In this case the neurotransmitter also shuts off the stem cells and keeps them dormant.

The brain stem cell population in mice (and other mammals, including humans) is surrounded by as many as 10 different kinds of intermingled neurons, says Song, and any number of these may be keeping stem cells dormant. To find out which neurons control the stem cells, the researchers inserted special light-activating proteins into the neurons that trigger the cells to send an electrical pulse, as well as to release neurotransmitter, when light shines on them. By shining light to activate a specific type of neuron and monitoring the stem cells with an electrode, Songs team showed that one of the three types of neurons tested transmitted a signal to the stem cells causing a change in electrical charge in the stem cells. The neurons messaging the stem cells are parvalbumin-expressing interneurons.

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Brain's Stem Cells "Eavesdrop" to Find Out When to Act

Emma, a snow-white German shepherd, has been plagued with arthritis for two years, limping and sometimes crying out in pain. But an innovative new procedure using her own stem cells has helped, her veterinarian and owner say.

"Her joint mobility has improved. I can move her elbows into a flexed position now," said Kristina Hansson, a veterinarian with San Rafael's Northbay Animal Hospital. Hansson injected Emma's own stem cells into 10 of her joints three months ago in a yet-unproven procedure that cost about $2,000, promoted by MediVet America, a Kentucky company.

"We're very pleased," said Arthur Latno of San Rafael, owner of the 9-year-old, 80-pound dog. "She doesn't limp any more and she doesn't cry."

Latno

He is apparently one of the first Marin pet owners to do so. Though there are some practitioners in Marin who use stem cell therapy, it is not yet widespread, according to Andrew Lie, a veterinarian at the East San Rafael Veterinary Clinic and president of the Marin County Veterinary Medical Association.

Lie himself doesn't use the therapy. "Personally, I think I would wait to see more research and studies come out. I think it's a little early

"This (the stem cell procedure) is incredibly promising, but on the other hand there is a lot of homework that needs to be done to determine whether these are valid therapeutic measures," said John Peroni, an associate professor at the University of Georgia College of Veterinary Medicine.

Peroni also chairs the North American Veterinary Regenerative Medicine Association. Peroni himself, along with colleagues at other universities including the University of California at Davis, is engaged in controlled clinical trials involving stem cells and animals. When such trials, peer-reviewed work and long-term studies are published, the effectiveness of the procedures will be easier to determine.

Dogs aren't the only mammals getting stem cell therapy for arthritis. The treatment is being used on humans as well. One example is the Centeno-Schultz Clinic in Broomfield, Colo, which offers a treatment called Regenexx that has received a good deal of media coverage. As with the animal procedure, it involves using a patient's own stem cells.

When the term "stem cells" is used, it brings to mind controversial procedures involving human embryos. In the MediVet procedure, however, the stem cells come from the animal's own body.

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San Rafael dog gets arthritis relief from stem cell treatment

ANN ARBOR In the first human study of its kind, researchers found that using stem cells to re-grow craniofacial tissues mainly bone proved quicker, more effective and less invasive than traditional bone regeneration treatments.

Researchers from the University of Michigan School of Dentistry and the Michigan Center for Oral Health Research partnered with Ann Arbor-based Aastrom Biosciences Inc. in the clinical trial, which involved 24 patients who required jawbone reconstruction after tooth removal.

Patients either received experimental tissue repair cells or traditional guided bone regeneration therapy. The tissue repair cells, called ixmyelocel-T, are under development at Aastrom, which is a UM spinout company.

For a video of the procedure, see: http://youtu.be/lWu_DEJfZVk

In patients with jawbone deficiencies who also have missing teeth, it is very difficult to replace the missing teeth so that they look and function naturally, said Darnell Kaigler, principal investigator and assistant professor at the UM School of Dentistry. This technology and approach could potentially be used to restore areas of bone loss so that missing teeth can be replaced with dental implants.

William Giannobile, director of the Michigan Center for Oral Health Research and chair of the UM Department of Periodontics and Oral Medicine, is co-principal investigator on the project.

The treatment is best suited for large defects such as those resulting from trauma, diseases or birth defects, Kaigler said. These defects are very complex because they involve several different tissue types bone, skin, gum tissue and are very challenging to treat.

The main advantage to the stem cell therapy is that it uses the patients own cells to regenerate tissues, rather than introducing man-made, foreign materials, Kaigler said.

The results were promising. At six and 12 weeks following the experimental cell therapy treatment, patients in the study received dental implants. Patients who received tissue repair cells had greater bone density and quicker bone repair than those who received traditional guided bone regeneration therapy.

In addition, the experimental group needed less secondary bone grafting when getting their implants.

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Stem Cell Therapy Could Offer New Hope For Head, Mouth Injuries, Defects

When transplanted into guinea pig hearts, human heart muscle cells (pictured) can beat in time with resident cells.

MEDIMAGE / SPL

Damaged skin and liver can often repair themselves, but the heart rarely heals well and heart disease is the world's leading cause of death. Research published today raises hopes for cell therapies, showing that heart muscle cells differentiated from human embryonic stem cells can integrate into existing heart muscle[1].

What we have done is prove that these cells do what working heart muscles do, which is beat in sync with the rest of the heart, says Chuck Murry, a cardiovascular biologist at the University of Washington in Seattle, who co-led the research.

It has been difficult to assess cell therapies in animal models because human cells cannot keep up with the heart rates of some small rodents. Cardiomyocytes derived from human embryonic stem (ES) cells typically beat fewer than 150 times a minute. External electrical stimulation can increase that rate, but only up to about 240 beats per minute, says Michael LaFlamme, a cardiovascular biologist at the University of Washington and the other co-leader on the project. Rats and mice have heart rates of around 400 and 600 beats per minute, respectively.

However, guinea pigs have a heart rate of 200250 beats per minute, near the limit for human cardiomyocytes. After working out ways to suppress guinea pigs immune systems so that they would accept human cells, Murry, LaFlamme and their co-workers began transplantation experiments. They also devised a way to make assessing electrical activity straightforward: using recent genetic-engineering technology, they inserted a sensor gene into the human ES cells so that cardiomyocytes derived from them would fluoresce when they contracted.

From the first experiment with the sensor in guinea pigs, it was obvious that the transplanted cells were beating in time with the rest of the heart, says LaFlamme. When he looked into the chest cavity, the heart was flashing back at us, he says.

The human cells seemed to aid healing: four weeks after the researchers killed regions of the guinea pigs hearts to simulate a heart attack, the hearts of animals that received cardiomyocytes exhibited stronger contractions than those that received other cell types. And cardiomyocyte transplants did not seem to cause irregular heartbeats, a common concern for cell-replacement therapy in the heart. In fact, the transplants seemed to suppress arrhythmias.

But it will be a long road from demonstrating this sort of integration to demonstrating possible therapeutic benefits, says Glenn Fishman, a cardiologist at New York University Langone School of Medicine, who was not involved in the work. The conclusion that the human cells can connect with the guinea pig tissue is true, he says, but the clinical implications are a bit of a stretch.

Cardiomyocytes engrafted in only a tiny percentage of scar tissue, Fishman explains, and the area seems too small to produce much additional pumping force. He suspects that the benefits seen stem from the 'paracrine effect', in which transplanted cells secrete factors that rejuvenate damaged host tissue. In fact, many researchers are exploring such strategies to prompt damaged heart tissue to restore itself, he says.

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Guinea pig hearts beat with human cells

AP

Raiders linebacker Aaron Curry isnt sure when hell be able to get back on the field, but hes pretty sure that stem cell therapy will be the thing that winds up getting him back there.

Paul Gutierrez of CSNBayArea.com reports that Curry has received the therapy on both of his knees. Bone marrow from his hips was used in the treatment and Curry told Gutierrez that it is the only thing hes tried that has helped him feel better. Curry is still working out on the side during Raiders practices and said hell only return to practice when hes fully able to help the Raiders.

My goal is to get healthy and just go out there and be violent, be fast, be a pain in the offenses butt and whatever I have to do on the defense, do it, Curry said. And do it full speed. I cant do that until my body says its ready.

The treatment has been popular with Oakland athletes. Linebacker Rolando McClain said that the treatment helped his legs feel better earlier this offseason and As pitcher Bartolo Colon has credited stem cell treatment on his shoulder with saving his baseball career.

With McClain facing a possible suspension under the Personal Conduct Policy and Oakland short on linebacking depth, the Raiders need Curry to be healthy for the start of the season.

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Aaron Curry using stem cell therapy to help knees

Take a close look at the athletes competing in this year's Summer Olympic Games in London --their musculature will tell you a lot about how they achieved their elite status. Endless hours of training and commitment to their sport played a big role in building the bodies that got them to the world's premier athletic competition. Take an even closer look--this one requires microscopy--and you'll see something else, something embedded in the genetic blueprints of these young men and women that's just as important to their success. [More]

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From Nature magazine

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One day in early 1995 a man named bob massie walked into my office at the outpatient clinic of Massachusetts General Hospital in Boston. Massie told me he had been infected with HIV--the virus that causes AIDS--for 16 years and yet had never shown any symptoms. My physical examination confirmed he was healthy, in stark contrast to all other patients I saw that day. At that time, a new combination of drugs was being tested that would eventually slow the progressive decline in immune function that HIV caused. In 1995, however, most people who had been infected with HIV for a decade or more had already progressed to AIDS--the stage marked by the inability to fight off other pathogens. The young man standing before me had never taken anti-HIV medication and strongly believed that if I learned the secret to his good fortune, the information could help others to survive what was then generally thought to be a uniformly fatal disease.

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Tears and a runny nose can be unpleasant on a windy day, but these mucosal secretions play a vital role in protecting the body from viruses and other malicious microbes. Unfortunately, mucus is also adept at washing away medication designed to treat infections and inflammation that occur when an infectious agent is successful in penetrating the body's defenses [More]

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Proposition 71 last week once again
stood in the way of action by the $3 billion California stem cell
agency.

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