Stem Cell Clinic

Scientists at The New York Stem Cell Foundation and Columbia University Medical Center Develop Scientific Technique To …

A new study published in Nature shows how mitochondrial disease may be prevented

NEW YORK, Dec. 19, 2012 /PRNewswire-USNewswire/ -- A joint team of scientists from The New York Stem Cell Foundation (NYSCF) Laboratory and Columbia University Medical Center (CUMC) has developed a technique that may prevent the inheritance of mitochondrial diseases in children. The study is published online today in Nature.

Dieter Egli, PhD, and Daniel Paull, PhD, of the NYSCF Laboratory with Mark Sauer, MD, and Michio Hirano, MD, of CUMC demonstrated how the nucleus of a cell can be successfully transferred between human egg cells. This landmark achievement carries significant implications for those children who have the potential to inherit mitochondrial diseases.

Mitochondria are cellular organelles responsible for the maintenance and growth of a cell. They contain their own set of genes, passed from mother to child, and are inherited independently from the cell's nucleus. Although mitochondrial DNA accounts for only 37 out of more than 20,000 genes in an individual, mutations to mitochondrial genes carry harmful effects.

Mitochondrial disorders, due to mutations in mitochondrial DNA, affect approximately 1 in 10,000 people, while nearly 1 in 200 individuals carries mutant mitochondrial DNA. Symptoms, manifesting most often in childhood, may lead to stunted growth, kidney disease, muscle weakness, neurological disorders, loss of vision and hearing, and respiratory problems, among others. Worldwide, a child is born with a mitochondrial disease approximately every 30 minutes, and there are currently no cures for these devastating diseases.

"Through this study, we have shown that it should be possible to prevent the inheritance of mitochondrial disorders," said Egli, PhD, co-author of the study and a Senior Researcher in the NYSCF Laboratory. "We hope that this technique can be advanced quickly toward the clinic where studies in humans can show how the use of this process could help to prevent mitochondrial disease."

In this study, the researchers removed the nucleus of an unfertilized egg cell and replaced it with the nucleus of another donor's egg cell. The resultant egg cell contained the genome of the donor but not her mitochondrial DNA. The researchers demonstrated that the transfer did not have detectable adverse effects on the egg cell, a prerequisite for clinical translation. They achieved this by lowering the temperature of the egg before nuclear transfer, a novel technique. Previous studies report adverse consequences in approximately 50% of the egg cells.

The researchers then artificially activated the egg cell through a technique called parthenogenesis and derived stem cell lines from the blastocyst that developed. These cell lines were grown for more than a year and generated adult cell types such as neurons, heart cells and pancreatic beta cells that are affected by mutant mitochondrial DNA. They found the levels of the donated genome's original mitochondria to be undetectable, demonstrating that this would permanently eliminate the mitochondrial DNA and prevent a family's future generations from developing these diseases.

Current treatment options to prevent mitochondrial disease are limited. A woman with a family history of mitochondrial disease may abstain from having children. She may alternatively elect to undergo in vitro fertilization (IVF) with donor eggs; however, this means the child will be genetically unrelated to her. As another option, patients can undergo IVF treatment and, through prenatal screening, to allow clinicians to select from a mother's eggs those that have the least likelihood of carrying mitochondrial DNA defects. This is not, however, a fully effective screening process, and her children may still be affected by mitochondrial disorders.

"Women who carry mutant mitochondrial DNA may no longer have to worry that their children will become sick. This technique may allow us to provide women with a therapeutic option that will prevent these disorders," said Sauer, MD, a co-author on the paper and Vice Chairman of the Department of Obstetrics and Gynecology and Chief of Reproductive Endocrinology at Columbia University Medical Center. Sauer is also Program Director of Assisted Reproduction at the Center for Women's Reproductive Care.

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Scientists at The New York Stem Cell Foundation and Columbia University Medical Center Develop Scientific Technique To ...

BrainStorm and Octane to Develop Revolutionary Bioreactor-Based NurOwn Stem Cells Production Process

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has signed an agreement with Octane Biotech of Kingston, Ontario, to jointly develop a proprietary bioreactor for production of its NurOwn stem cell therapy candidate. The customized bioreactor will enable BrainStorm to optimize its NurOwn production process, significantly increasing its production capabilities by using a single clean room for multiple patients, reducing costs and time. The project is supported by a grant awarded by the Canada-Israel Industrial Research and Development Foundation (CIIRDF).

Under the terms of the agreement, the companies will develop a commercially viable, safe, reliable, and cost-effective bioreactor for scale-up of BrainStorms NurOwn stem cell therapy, using Octanes Automated Cell & Tissue Engineering System (ACTES) technology. The CIIRDF funding award was approved for a period of three years.

Octane is the ideal partner for us, since they have a particular expertise in developing automated production processes for mesenchymal cell therapy technologies, commented Dr. Adrian Harel, BrainStorms CEO. We are anxious to move ahead with this project, in order to be in a position to provide NurOwn as quickly as possible, and to as many patients as possible, in the near future.

The opportunity to work with BrainStorm on scaling-up the NurOwn production process is a particularly meaningful one, given the urgency of its target population, said Dr. Tim Smith, Octanes CEO. We are confident that our combined knowledge base and commitment to the project will help advance their product significantly closer to clinical use.

BrainStorm is currently conducting a Phase I/II clinical trial in ALS patients at the Hadassah Medical Center in Jerusalem and is planning to expand its clinical development in the USA, pending FDA approval. Towards that goal, the Company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS human clinical trials at these institutions.

About BrainStorm Cell Therapeutics

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.

About Octane Biotech

Octane develops innovative bioreactor-based systems to meet the production challenges inherent in the progressive scale-up of manual cell culture protocols. The companys unique Automated Cell & Tissue Engineering System (ACTES) solution integrates state-of-the-art bioreactors, biosensors and bioprocessing to enable routine GMP production of cell-based products for clinical therapeutics. Octane Biotech Inc. is one of three affiliated companies within the Octane Medical Group. For more information, visit the companys website at http://www.octaneco.com.

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BrainStorm and Octane to Develop Revolutionary Bioreactor-Based NurOwn Stem Cells Production Process

BioTime Reports Isolation of Seven Diverse Cartilage and Bone Cell Types From Human Embryonic Stem Cells

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, and its subsidiaries OrthoCyte Corporation and LifeMap Sciences reported today a means of manufacturing seven distinct types of cartilage, bone, and tendon cells from human embryonic stem cells. The paper, scheduled to be published online (ahead of print) at 1600 GMT today in the peer-reviewed journal Regenerative Medicine, characterizes the seven cell types generated using BioTimes proprietary PureStemTM technology. The study compared the novel cells with adult stem cells, known as mesenchymal stem cells (MSCs), and revealed properties of the new cell lines that are suggestive of a wide array of future applications in the practice of orthopedic medicine.

In the study published today, it was demonstrated that BioTimes cells, which can be manufactured on an industrial scale, are progenitors to diverse skeletal tissues of the human body. These cell lines bear diverse molecular markers that distinguish them from each other and from MSCs. The molecular markers of BioTimes cell lines suggest the lines may therefore be applicable to the repair of different types of bone, cartilage, and tendon for the treatment of degenerative diseases afflicting these tissue types such as non-healing bone fractures, osteoarthritis and degeneration of intervertebral discs, and tendon tears (tendinosis).

Chronic orthopedic disorders such as osteoarthritis, degeneration of the discs in the spine, osteoporosis, and tendon tears are among the leading complaints and causes of disability in an aging society. The recent isolation of new pluripotent stem cells such as human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells opens the door to the manufacture of all of the cell types in the human body on an industrial scale. These achievements in the emerging field of regenerative medicine have made it feasible to introduce new modalities of repairing these and other tissues in the body.

As promising as these new stem cells may be for eventual human tissue repair, there has been little progress to date in identifying new ways to generate pure populations of the diverse cellular components of the human body using methods that are also compatible with industrial-scale manufacture. To address this need, BioTime scientists developed a novel and proprietary manufacturing process. These isolated PureStemTM(previously ACTCellerateTM) cell lines allow for the scale-up of more than 200 highly purified and identified cell types.

In today's publication, BioTime scientists reported on seven PureStemTM cell lines representing diverse cells of the developing human skeleton. One of these cell lines, 4D20.8, was previously shown by BioTime scientists to exhibit site-specific markers of craniofacial mesenchyme, and in particular, markers of proximal mandibular mesenchyme. This tissue type is of significance in that it naturally produces one of the strongest joint cartilages of the body. In todays report, this line was compared to the BioTimes lines 7PEND24, 7SMOO32, E15, MEL2, SK11, SM30, and to other commonly studied MSCs. BioTimes cell lines displayed markers that indicated the cells were progenitors of diverse cartilage, bone, and tendon cell types in the body.

There remains the need for safe methods of manufacturing cells at a high degree of purity and site-specific identity, in addition to an FDA-approvable combination with a matrix to facilitate the stable transplantation of those cells into the body. BioTimes HyStem technology is designed to be an effective means of transplanting cells in an injectable liquid that can polymerize safely in the body into a tissue construct. BioTime anticipates that during the first quarter of 2013, a submission of a Phase I safety trial in humans will be made to the appropriate European Committee for review and approval of HyStem formulated for the delivery of autologous fat-derived cells for skin applications, a product called Renevia. In todays publication, the seven novel osteochondral cell lines were demonstrated to be successfully differentiated in HyStem in laboratory experiments, supporting the potential use of the product together with these and other PureStemTM cell lines in combination products.

The studys demonstration of the manufacture of diverse site-specific tissue progenitors from pluripotent stem cells serves to highlight the utility of LifeMap Discovery, a powerful new database that provides a roadmap to the complex fabric of cells constituting the human body. In todays publication, BioTime and LifeMap scientists collaborated to map the molecular markers of the published PureStemTM cell lines within the database, thus making the lines available for the research community in the context of the human developmental tree.

We are gratified to finally report in a scientific publication the power of monoclonal human embryonic progenitor cell lines to scale diverse cell types of the human body, said Michael D. West, Ph.D., BioTime's Chief Executive Officer. Our confidence that many other cell types of the human body can be manufactured in this manner is the reason for our focus on this platform and for participating in building LifeMap DiscoveryTM to help the medical research community navigate this fascinating yet complex network of product development.

Arnold Caplan, Ph.D., OrthoCyte's Chief Scientific Officer and Director of the Skeletal Research Center at Case Western Reserve University, commented that the paper by Sternberg and colleagues emphasizes the scalability of clonal human embryonic stem cell-derived cell lines for musculoskeletal tissue engineering.The analysis at the molecular level of the biological markers gives us confidence that these groups of cells can be used for cartilage repair and regeneration. The amount of cells that can be generated is really practical for human musculoskeletaltissue regeneration.

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BioTime Reports Isolation of Seven Diverse Cartilage and Bone Cell Types From Human Embryonic Stem Cells

BrainStorm Deferring Shareholders Conference Call in Anticipation of Upcoming Developments

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that it is deferring its shareholders conference call scheduled for December 11, 2012, in anticipation of significant positive company developments likely to be released shortly. The company will announce the re-scheduled conference call date as soon as senior management is authorized to discuss these developments.

About BrainStorm Cell Therapeutics

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of adult stem cell therapeutic products derived from autologous bone marrow cells and intended for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel-Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.

Safe Harbor Statement

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as may, should, would, could, will, expect, likely, believe, plan, estimate, predict, potential, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorms forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or managements beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm Deferring Shareholders Conference Call in Anticipation of Upcoming Developments

New Research Shows Significant Improvement in Survival for Patients Receiving Unrelated Blood Stem Cell Transplants

ATLANTA--(BUSINESS WIRE)--

Survival rates have increased significantly over the past decade among patients with leukemia and other life-threatening diseases who received blood stem cell transplants from donors outside of their families, according to new research1.

Results of the recent study presented at the 54th Annual Meeting of the American Society of Hematology in Atlanta showed that the one-year survival rate for all unrelated transplant patients improved 12 to 13 percent between 2000 and 2009, and a large percentage of patients maintained improvements through their three-year follow-up.

The retrospective cohort study analyzed outcomes for more than 15,000 unrelated transplant patients and was led by the National Marrow Donor Program (NMDP) and its research arm, the Center for International Blood and Marrow Transplant Research (CIBMTR). The significant improvements are correlated with reduced treatment-related mortality, and in certain populations, fewer disease relapses.

Such a remarkable improvement in outcomes demonstrates that unrelated transplantation is a good option for the 70 percent of patients who need a transplant, but dont have a suitable matching donor within their family, said Navneet Majhail, M.D., lead author of the study and medical director at the NMDP. This is good news for these patients, and should reassure physicians about the safety and efficacy of referring a patient for an unrelated transplantation.

In fact, the study again confirmed that those patients who received transplants earlier in their disease fared far better than those with advanced disease, emphasizing the importance of earlier referrals by physicians.

The data confirms that physicians working with patients who are fighting a blood cancer should consider unrelated transplantation as a standard therapy, continued Dr. Majhail. Multiple factors have likely contributed to this dramatic improvement in survival, including advances in HLA tissue typing, better supportive care, less intensive conditioning regimens, new medications to treat post-transplant complication and a growing, diverse registry of volunteer bone marrow donors.

The NMDPs Be The Match Registry today includes more than 10 million potential bone marrow donors, compared to 3.5 million in 2000.

The transplantation community has gained enormous knowledge over the past decade, evidenced by the significant improvements in patient survival, said Jeffrey W. Chell, M.D., chief executive officer of the NMDP. Unrelated blood stem cell transplantation is no longer a last resort for patients battling life-threatening blood cancers.

About the National Marrow Donor Program(NMDP)

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New Research Shows Significant Improvement in Survival for Patients Receiving Unrelated Blood Stem Cell Transplants

Bioheart in Partnership With NorthStar on Physician Training in Stem Cell Techniques

SUNRISE, FL--(Marketwire - Dec 10, 2012) - Bioheart Inc. ( OTCQB : BHRT ) previouslyannounced that it is working with NorthStar Biotech to help promote regenerative medicine.NorthStar has announced that it will subsidize physicians to participate in the Ageless Regenerative Institute stem cell training program.The fully accredited CME training program includes a didactic lecture series followed by hands-on clinical training for physicians to learn to isolate stem cells for immediate use in their patients.The Ageless Regenerative Institute has successfully trained over 200 physicians and these physicians are utilizing both adipose and bone marrow derived stem cells as well as platelet rich plasma for orthopedics, aesthetics and other degenerative diseases.

With the new NorthStar/Bioheart program, this select group of physicians have the opportunity to receive full funding for the training and join a network of physicians who will offer in-clinic stem cell therapies.Once these physicians commence IRB-approved in-clinic services, Bioheart will receive royalties for the use of these fee-for-service procedures.Initial projections have not been announced by NorthStar.

"Physicians have for years evaluated and considered stem cell treatments as a potential alternative for a subset of our patient population.This program helps educate doctors and allows us a viable opportunity to expand our treatment portfolio for patients in need," said board-certified Miami internist Dr. Antonio Blanco.

Bioheart's president and CEO Mike Tomas said, "The training programs at the Ageless Regenerative Institute provide physicians with extraordinary regenerative medicine capabilities.We are fortunate to partner with Northstar to bring these therapies to the clinic."

Physicians interested in applying to participate in the program should contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research.ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more.ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy.For more information about regenerative medicine please visit http://www.agelessregen.com.

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Bioheart in Partnership With NorthStar on Physician Training in Stem Cell Techniques

Photo Release — GIOSTAR and the Government of India to Enter $2 Billion Stem Cell Therapy Program – Official State …

SAN DIEGO, Dec. 10, 2012 (GLOBE NEWSWIRE) -- The Global Institute Of Stem-cell Therapy And Research (GIOSTAR) announced today a collaborative treatment plan to serve the local population suffering from a genetic disease, Sickle Cell Anemia. President and CEO, Mr. Deven Patel and his team met with Honorable Chief Minister Shri Arjun Munda of State of Jharkhand, India in November 2012 to address the local population's medical needs.

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=16184.

As a follow-up, a government delegation representing the state of Jharkhand, India; Chief Minister, Principal Health Secretary, Chief Secretary and many other officials are visiting GIOSTAR in San Diego on December 14, 2012 to finalize the proposed two (2) billion U.S. dollar contract to be serviced over the next 15 years.

Bob Filner, Mayor of San Diego and City Council Members are among the invited guests for this state visit along with representatives from Belize and the island nation of Saint Vincent and the Grenadines.

Two hundred (200) jobs are estimated to be created in San Diego and it is expected that the dialog would include an economic development program between City of San Diego and State of Jharkhand, India.

GIOSTAR is a Global Private Funding (Global) incubated company. "Global is a private equity firm that focuses on funding projects and initiatives that are job-creation centric rather than just profit centric. We believe that a venture that draws the best minds and hearts to a unified goal, driven by a unified vision tends to be far stronger and less prone to failure than one driven by just profit. We invest in people, not the business," said Dr. Sam Senev, Chairman and CEO of Global. Senev added that GIOSTAR is a showcase client focused on both serving mankind through quality of life and job creation.

GIOSTAR, headquartered in San Diego, California (USA), was formed with the vision to provide stem cell based therapy to aid those suffering from degenerative or genetic diseases around the world. We are the leaders in developing innovative stem cell based technology.

The Chairman and Cofounder of GIOSTAR, Dr. Anand Srivastava and our team of scientists and clinicians have been associated with leading universities and research institutions throughout USA. GIOSTAR team has extensive research and clinical experience in the field of Stem cell, which is documented by several publications in revered scientific journals.

GIOSTAR in July 2011, inaugurated the world's first dedicated stem cell treatment hospital, a 125-bed, contemporary facility with the most advanced on-site stem cell laboratory. This hospital is fully operational. GIOSTAR is developing the world's largest, a three hundred thousand square-foot (300,000SF) state-of-the-art, Stem Cell Treatment Hospital in the Surat Civil Hospital Campus in collaboration with the government of Gujarat. Negotiations are ongoing with China, Philippines, Bahamas, Belize, Thailand, Ukraine and the Middle East to open regional stem cell treatment hospitals and satellite clinics throughout those countries and regions. "We are expanding the GIOSTAR footprint and is in negotiations to open locations near Austin Texas, Phoenix Arizona, and Savannah South Carolina" said Michael Andersen, Vice President of Venture Management at Global. Global and Empyrean West, EB-5 administrators, plan to invest over one hundred and eighty million ($180M) in economic development investments for GIOSTAR projects.

The Global Institute of Stem Cell Therapy and Research company logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=16183.

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Photo Release -- GIOSTAR and the Government of India to Enter $2 Billion Stem Cell Therapy Program - Official State ...

Advances in Stem Cell Research Techniques and New Transplant Strategies Reveal Opportunities for Improved Patient …

ATLANTA, Dec. 9, 2012 /PRNewswire-USNewswire/ -- Studies of stem cell biology and transplant approaches presented today at the 54th Annual Meeting of the American Society of Hematology (ASH) illustrate how the use of advanced modeling techniques is optimizing stem cells to treat patients with blood disorders, as well as the potential of enhanced treatment strategies to improve the success rate of hematopoietic stem cell (HSC) transplantation for these patients.

Hematopoietic stem cell transplantation is effectively used today as a form of "replacement" therapy for patients with hard-to-treat blood conditions, providing healthy HSCs to help patients whose bodies cannot properly fight infection or disease on their own. While transplants often lead to long-term remission for many patients, researchers are now challenging traditional assumptions in an effort to further improve success rates while minimizing the remaining risks associated with transplantation.

"As we learn more about the biology and therapeutic use of hematopoietic stem cells to cure blood disorders, we are able to refine our traditional approaches to reduce complications and deliver better patient benefits," said Vanderson Rocha, MD, PhD, moderator of the press conference and Professor of Hematology of Oxford University, United Kingdom. "We are finding that hematopoietic stem cells can be programmed in ways we previously did not think possible, a discovery that may lead to the development of important new therapeutic strategies."

This press conference will take place on Sunday, December 9, at 10:00 a.m. EST.

Targeting Histone Deacetylases as a New Strategy for Graft Versus Host Disease Prevention [Abstract 740]

New research shows that the addition of the oral anti-cancer agent vorinostat to standard therapy given before, during, and after hematopoietic stem cell transplantation (HSCT) may safely reduce the incidence and severity of a challenging complication called graft-versus-host disease (GVHD).

HSCT is the primary form of treatment for many patients with blood disorders; it involves the transplantation of healthy blood-forming stem cells from the bone marrow, circulating blood, or umbilical cord blood to replace damaged, disease-causing cells in recipients. Despite the therapeutic benefits of HSCT, half of all patients who receive transplants from a related donor (allogeneic HCT) develop acute GVHD, a life-threatening condition occurring when the newly transplanted cells identify the recipient's body as foreign and attack the recipient's own cells.

Currently, HSCT patients receive prophylactic therapy before and after transplant to prepare their bodies for the procedure and to help manage their subsequent immune response. While this series of drugs is designed to help reduce patients' risk of developing GVHD, it also compromises their immune systems, leaving them vulnerable to serious infections and complications. Recent research has sought to determine ways to improve patients' initial immune response to transplanted cells as well as promote faster immune recovery after transplant.

Recent early-stage studies have demonstrated that a class of anti-cancer drugs known as histone deacetylase inhibitors (HDACi) may safely reduce the risk of GVHD in patients. These drugs have demonstrated an ability to "turn off" an enzyme that leads to inflammation, a major contributor to GVHD that develops as a byproduct of patients' intense immune response to HSCT. Based on those early results, researchers initiated the current study to evaluate whether one drug in this class, vorinostat, might reduce the risk of acute GVHD when added to current regimens.

To test this hypothesis, researchers enrolled 45 patients undergoing matched related donor HSCT from transplant centers at the University of Michigan in Ann Arbor, Mich. and Washington University in St. Louis to compare results of a standard regimen with vorinostat to historical controls. The primary endpoint of the single-arm, Phase I/II trial was the cumulative incidence of grade 2-4 acute GHVD (grade 1 is mildest; grade 4 is most severe). They aimed for an incidence of no more than 25 percent, compared with historical average rates of 42 percent.

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Advances in Stem Cell Research Techniques and New Transplant Strategies Reveal Opportunities for Improved Patient ...

Cytomedix Announces Positive Results With Angel(R) cPRP in Veterinary Application

GAITHERSBURG, MD--(Marketwire - Dec 7, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that positive data on the Angel cPRP system in a veterinary application -- treatment of persistent mating induced endometritis (PMIE) in mares -- were recently presented at the 3rd annual conference of the North American Veterinary Regenerative Medicine Association (NAVRMA) in Savannah, GA.Treatment with PRP was shown to be associated with a statistically significant reduction in certain endometrial pro-inflammatory cytokines and inducible nitric oxide synthetase (iNOS), both known to be involved in the pathology of PMIE.

Many mares fail to respond to conventional therapies and recent studies have shown a link between PMIE and the expression of certain cytokines.Nitric oxide is also believed to play a role in uterine clearance. The study investigated 9 barren mares with a history of PMIE. During the treatment cycle, whole blood was processed using the Angel cPRP system and the resultant PRP was brought to a final volume with platelet poor plasma and infused into the uterus. All mares were then inseminated with motile sperm.Evaluation of endometrial biopsies showed that in mares treated with PRP there was down-regulated expression of pro-inflammatory molecules, IL-1b, IL-6, IL-8 and iNOS, compared with untreated mares (p < 0.05).

Lisa Metcalf MS, DVM, Diplomate ACT, lead investigator on the study commented on the results, "Infertility in high value mares is a significant economic problem in the equestrian industry.Intra uterine treatment with PRP offers a new approach to treating this condition and, in this study we observed multiple pregnancies in the treated mares that were previously barren. Use of PRP in this setting warrants further investigation".

Martin Rosendale, Chief Executive Officer of Cytomedix added, "These results are very promising and give us further insight into the mechanism by which PRP inhibits inflammation by decreasing the presence of pro-inflammatory cytokines. These findings regarding the control of inflammation may be transferable to human inflammatory conditions. We will continue to explore disease areas where inflammation is known to play a role and where there is a need for a therapeutic alternative to corticosteroids."

About Cytomedix, Inc. Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. The Company markets the AutoloGel System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture of blood and bone marrow, into red cells, platelet poor plasma ("PPP") and PRP in surgical settingsOn February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit cytomedix.com

Safe Harbor StatementStatements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix Announces Positive Results With Angel(R) cPRP in Veterinary Application

Cytomedix Announces Landmark Bright Cell Therapy Study in Peripheral Arterial Disease

GAITHERSBURG, MD--(Marketwire - Dec 6, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today the signing of an agreement with NIH to collaborate on a Phase 2 clinical study in patients with intermittent claudication (IC).IC is caused by peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles of the leg. The study is being funded by NHLBI/NIH and managed by the Cardiovascular Cell Therapy Research Network (CCTRN), which is also responsible for enrolling patients. The CCTRN is a network that includes seven centers in the United States with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases.

The Phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.The primary endpoints of the study are safety and the change in peak walking time at 6 months compared to baseline.Additionally, changes in leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging (MRI) will be examined. These novel MRI techniques are incorporated into the study to assess perfusion, providing a unique set of data potentially supporting the angiogenic mechanism of Bright Cells.The clinical study has received Investigational New Drug approval from the U.S. Food and Drug Administration (FDA) and is expected to begin enrollment in Q1 2013 upon the Investigational Review Board approvals from the participating centers.

Martin P. Rosendale, Chief Executive Officer of Cytomedix, stated, "We are delighted that the CCTRN has chosen to collaborate with Cytomedix on this study.Our February acquisition of Aldagen and the Bright Cell technology has positioned us well to play a leading role in investigating promising clinical paths in regenerative medicine where there exists significant unmet medical need.We look forward to supplying a highly differentiated personalized cell therapy product to the participating CCTRN centers involved with this important PAD indication.Intermittent claudication is a serious consequence of arteriosclerosis which, if left untreated, will likely progress to pain at rest and possibly open wounds.Our experience with the AutoloGel product and the clinical treatment of lower extremity wounds resulting from CLI has provided us with a full appreciation of the difficult clinical outcomes associated with this compromised patient population.We are hopeful that improvements in lower leg blood flow will lead to increased peak walking time which has been accepted as an FDA approvable endpoint in pivotal Phase 3 trials in IC."

"This is the first randomized clinical trial to look at the benefits of autologous stem cell therapy in PAD patients with IC. It will collect important mechanistic and clinical information on the efficacy and safety of the direct injection of Bright Cells into these patients. It will also evaluate the utility of advanced imaging endpoints that could be used in the future to further understand the impact of novel therapies in this patient population," added Lem Moy, M.D., Ph.D., professor of biostatistics at the University of Texas School of Public Health, Houston, and co-author of the study protocol.

PAD is a major unmet medical need affecting approximately 8 to 10 million patients in the U.S. IC is a significant subset of the PAD population and is characterized by pain in the lower legs while in motion that resolves upon rest.Critical limb ischemia (CLI) is the advanced form of PAD, and is associated with poor clinical outcomes and increased morbidity.An important goal of medical intervention is to attempt to prevent the progression of patients from IC to CLI.This clinical studybuilds on the strong data showing increased blood flow and improved clinical status from Cytomedix's previous Phase 1/2 study of ALD-301 in CLI published last year ("A Randomized, Controlled Study of Autologous Therapy with Bone Marrow-Derived Aldehyde Dehydrogenase Bright Cells in Patients with Critical Limb Ischemia" Catheterization and Cardiovascular Interventions 2011).In the PACE study, ALD-301 will be delivered in the same manner, via direct, intramuscular injection in a grid pattern of the affected lower limb.Cytomedix will be responsible for manufacturing ALD-301 for the clinical trial and will have certain rights todata generated during the trial.

About ALD-301/ALDH Bright CellsALD-301 is a population of autologous pluripotent stem cells isolated from the patients' bone marrow using Cytomedix' proprietary Bright Cell technology.These adult stem cells express high levels of the enzyme ALDH, an indicator of biological activity in heterogeneous early stage stem cells.Preclinical research suggests that ALD-301 may promote the repair of ischemic tissue damage by producing signaling molecules that are involved in cell recruitment, cell adhesion, and angiogenesis.

About Cardiovascular Cell Therapy Research Network (CCTRN) and NHLBIThe CCTRN includes seven main stem cell centers in the United States with experience and expertise in clinical trials studying treatments for cardiovascular diseases.They are the Texas Heart Institute, the University of Florida at Gainesville, Minneapolis Heart Institute, Stanford University, University of Louisville, University of Miami and the Vascular and Cardiac Center for Adult Stem Cell Therapy in Indianapolis, Indiana.The CCTRN has successfully completed and published the results of three adult stem cell trials to date (TIME, LateTIME, and FOCUS).Further information on CCTRN is available at: cctrn.org.

The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health. NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available at: nhlbi.nih.gov.

About Cytomedix, Inc. Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. The Company markets the AutoloGel System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel cPRP System, a blood processing device and disposable products used for the separation of blood and bone marrow into red cells, platelet poor plasma ("PPP") and PRP in surgical settings.On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit cytomedix.com

Safe Harbor StatementStatements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix Announces Landmark Bright Cell Therapy Study in Peripheral Arterial Disease