RNL BIO Co. Ltd. Files IND To Commence Phase II Clinical Trial Of RNL-JointStem For Osteoarthritis In The United States

GERMANTOWN, Md., May 2, 2013 /PRNewswire/ -- RNL BIO, a stem cell biotechnology company dedicated to the commercialization of autologous cell therapy products for a variety of degenerative, ischemic and other indications, has announced that it has filed an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) to begin clinical trials with its adipose-derived stem cell product, termed RNL-JointStem, for the treatment of osteoarthritis (OA). Assuming approval of the IND by the Center for Biologics Evaluation and Research (CBER) at the FDA, RNL BIO plans to initiate its double-blinded, randomized, positive-control Phase II clinical trial during the third quarter of 2013 in Sugarland, Texas. Dr. Jason Dragoo of Stanford University and Dr. David Alan Fisher of Indiana University acted as reviewers and completed revision of the protocol now under evaluation by the FDA. Phase I and Phase II clinical trials of RNL-JointStem have already been completed under the authority of the Korean Food and Drug Administration (KFDA).

"We are excited about filing an IND for RNL-JointStem because it brings us closer to a clinical trial with RNL-JointStem in the United States," said Jeong-Chan Ra, CEO and Chairman of RNL BIO. "Our goal for this trial is to achieve global demonstration that RNL-JointStem is efficacious. If our trial is successful it can lead to a paradigm shift in the treatment of osteoarthritis, using stem cell products derived from a patient's own fat tissue." Among the key advantages demonstrated in previous trials of RNL-JointStem is that it is administered in a single injection, unlike the many invasive treatments currently used in the treatment of OA. "Treatments of this painful chronic condition should relieve pain, not add to it," said Dr. Ra. "We hope to confirm the efficacy of RNL-JointStem for cartilage regeneration, pain reduction and joint function improvement for OA patients, and that it will see market approval in due course."

The clinical trial will compare RNL-JointStem to existing modalities utilizing hyaluronic acid (HA). The patient population for this initial clinical trial will include patients diagnosed with osteoarthritis and whose clinicians judge that they meet candidacy requirements. The intended market for RNL-JointStem is patients under 60 years of age for whom there is no efficacious therapy at present.

About Osteoarthritis

Degenerative arthritis is the most common type of arthritis. It is estimated that 26.9 million Americans 25 years old or older have clinical degenerative arthritis of some joints, with a higher percentage of affliction in the older population. Its clinical manifestations include joint pain and impairment to movement, and surrounding tissues are often affected with local inflammation. The etiology of degenerative arthritis is not completely understood; however, injury, age, and genetics have been considered among the risk factors.

Degenerative arthritis is a progressively debilitating disease that affects mostly cartilage, with associated changes in bone. Cartilage has limited intrinsic healing and regenerative capacities.

Through this trial

Due to the increasing incidence of degenerative arthritis and the aging population coupled with inefficient therapeutic choices, novel cartilage repair strategies are in need. The market for a therapeutically efficacious product for this indication is estimated to be very large.

About an IND

An Investigational New Drug (IND) is a procedure for the authorization to perform a clinical trial in the United States. An IND is required whenever the performance of a clinical trial in the United States is intended. The IND includes information related to the quality, manufacture and control of the Investigational Medicinal Product, data from pre-clinical studies and clinical intent-to-use. An overall risk-benefit assessment, critical analyses of the pre-clinical data in relation to the potential risks and benefits of the proposed study are required to be part of the IND.

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RNL BIO Co. Ltd. Files IND To Commence Phase II Clinical Trial Of RNL-JointStem For Osteoarthritis In The United States

Stem cell discovery could aid research into new treatments

May 2, 2013 Scientists have made a fundamental discovery about how the properties of embryonic stem cells are controlled.

The study, which focuses on the process by which these cells renew and increase in number, could help research to find new treatments.

Researchers have found that a protein, which switches on genes to allow embryonic stem cells to self-renew, works better when the natural occurring level of the protein is reduced.

It was previously thought that once levels of this protein -- called Oct 4 -- were reduced the numbers of new stem cells being produced would also fall.

The finding will inform stem cell research, which is looking to find treatments for conditions including Parkinson's, motor neuron, liver and heart disease.

During embryonic development, cells that have the capacity to become any cell type in the body -- called pluripotent stem cells -- can either renew themselves by multiplying in number or differentiate to become cells found in different parts of the body, for instance skin or liver.

This need for pluripotent cells to increase in number is important so that there is a sufficient supply of them to be differentiated into other cell types.

Scientists at the Medical Research Council Centre for Regenerative Medicine at the University of Edinburgh found that when there were lower levels of Oct 4, the protein bound much more tightly to key parts of DNA in cells.

The strong attraction of Oct 4 to these sections of DNA enabled the efficient switching on of key genes that caused pluripotent stem cells to renew.

The findings could help to improve the way in which stem cells are cultured in the laboratory, providing a better understanding of the processes needed for cells to divide and multiply or to generate different cell types.

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Researchers outline concerns about unproven stem cell therapies

May 3, 2013 An international group of leading stem cell researchers has issued a statement that specifies concerns about the development and use of unproven stem cell therapies. The commentary is published online today in The EMBO Journal ahead of a debate in the Italian parliament on whether to change a recent law that allows certain untested stem cell therapies to be used by the public health system. The authors of the commentary argue that rigorous clinical testing and regulation of stem cell therapies are essential to introduce safe and effective medical interventions for patients.

"Stem cells may offer unprecedented opportunities to develop treatments for many diseases with unmet medical needs. This will take time. However, only rigorous science and responsible regulation can ensure the safe and effective translation of science into effective therapies," remarked Paolo Bianco, Pathologist, Stem Cell Biologist, Professor of Pathology at the University of Roma "La Sapienza" and one of the 13 authors of the commentary who come from Italy, Germany, the United Kingdom, The Netherlands and the United States.

The concerns of the scientific community have been heightened by pending legislative action that may allow routine administration of unproven stem cell therapies to patients in Italy. Despite a lack of rigorous clinical trials to test safety or efficacy, a ban of the treatment by health authorities, and a lack of peer review by the scientific community, the privately funded Stamina Foundation has been using cultured mesenchymal stem cells that have been exposed to putative conditions that favour neuronal differentiation to treat different diseases in severely or terminally ill patients.

The Italian Chamber decides shortly whether they will proceed with controversial legislation passed in the Senate on 21 March that allows the unproven stem cell treatment developed by the Stamina Foundation to be used for severely or terminally ill new patients for 18 months. "The adoption of this law may set a dangerous precedent for patients looking to be treated with other unproven stem cell therapies in Europe and other countries," remarked Hans Clevers, Professor of Molecular Genetics and President of the Royal Netherlands Academy of Arts and Sciences.

"Irrational and unverified stem cell treatments based on methods that are not validated or scientifically documented should not reach patients. Preventing this from happening is a specific responsibility of health authorities and governments worldwide to make sure that the hope and trust of patients are not misused," remarked Elena Cattaneo, Director of the Centre for Stem Cell Research at the University of Milan, Italy, and one of the scientists who contributed to the commentary. "Patients can be harmed and killed by medicines that have not been proven to be safe and effective via rigorously controlled clinical trials. The use of medicines that have not been manufactured to the highest possible standards is irresponsible."

Preclinical and clinical tests have been used successfully in the past for the introduction of therapies for bone marrow transplantation and the regeneration of skin and cornea in patients. The authors of the commentary emphasize that cell therapies must be approved by international and national regulatory agencies and remain under the strict vigilance of health authorities. Regulations already in place in the European Union insist that stem cell therapies follow the same safety and efficacy rules as pharmaceuticals. They need to be prepared and manufactured in highly controlled environments with precise protocols, traceability and accountability.

"It is disconcerting that the Italian Senate has passed amendments that permit the use of unproven stem cell therapies without proper vigilance or proper experiment, reclassifying them as transplants," commented Bianco. "Infusions of mesenchymal stem cells are not transplants in any way. In Europe and the United States, all kinds of cell preparations that are administered to patients following ex vivo culturing are classified as medicines, and monitored by drug agencies such as the US Food and Drug Administration, the European Medicines Agency and, in Italy, the Agenzia Italiana del Farmaco or AIFA. A host of proper and improper commercial interests might benefit from these new rules that abrogate both safety and proper ways of experimentation. Patients may be harmed," concluded Bianco.

Sean Morrison, Professor and Director of the Children's Medical Center Research Institute at UT Southwestern Medical Center in the United States, who is not an author on the paper, added: "Patients are ultimately not helped by therapies that are not based on sound science and that are not tested in systematic clinical trials. Efforts to water down regulation in this area may create opportunities for some individuals to prey on the hopes of desperate patients."

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Turning human stem cells into brain cells sheds light on neural …

May 2, 2013 Medical researchers have manipulated human stem cells into producing types of brain cells known to play important roles in neurodevelopmental disorders such as epilepsy, schizophrenia and autism. The new model cell system allows neuroscientists to investigate normal brain development, as well as to identify specific disruptions in biological signals that may contribute to neuropsychiatric diseases.

Scientists from The Childrens Hospital of Philadelphia and the Sloan-Kettering Institute for Cancer Research led a study team that described their research in the journal Cell Stem Cell, published online today.

The research harnesses human embryonic stem cells (hESCs), which differentiate into a broad range of different cell types. In the current study, the scientists directed the stem cells into becoming cortical interneurons a class of brain cells that, by releasing the neurotransmitter GABA, controls electrical firing in brain circuits.

Interneurons act like an orchestra conductor, directing other excitatory brain cells to fire in synchrony, said study co-leader Stewart A. Anderson, M.D., a research psychiatrist at The Childrens Hospital of Philadelphia. However, when interneurons malfunction, the synchrony is disrupted, and seizures or mental disorders can result.

Anderson and study co-leader Lorenz Studer, M.D., of the Center for Stem Cell Biology at Sloan-Kettering, derived interneurons in a laboratory model that simulates how neurons normally develop in the human forebrain.

Unlike, say, liver diseases, in which researchers can biopsy a section of a patients liver, neuroscientists cannot biopsy a living patients brain tissue, said Anderson. Hence it is important to produce a cell culture model of brain tissue for studying neurological diseases. Significantly, the human-derived cells in the current study also wire up in circuits with other types of brain cells taken from mice, when cultured together. Those interactions, Anderson added, allowed the study team to observe cell-to-cell signaling that occurs during forebrain development.

In ongoing studies, Anderson explained, he and colleagues are using their cell model to better define molecular events that occur during brain development. By selectively manipulating genes in the interneurons, the researchers seek to better understand how gene abnormalities may disrupt brain circuitry and give rise to particular diseases. Ultimately, those studies could help inform drug development by identifying molecules that could offer therapeutic targets for more effective treatments of neuropsychiatric diseases.

In addition, Andersons laboratory is studying interneurons derived from stem cells made from skin samples of patients with chromosome 22q.11.2 deletion syndrome, a genetic disease which has long been studied at The Childrens Hospital of Philadelphia. In this multisystem disorder, about one third of patients have autistic spectrum disorders, and a partially overlapping third of patients develop schizophrenia. Investigating the roles of genes and signaling pathways in their model cells may reveal specific genes that are crucial in those patients with this syndrome who have neurodevelopmental problems.

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International Stem Cell Corporation to Present at American Society …

CARLSBAD, CA(Marketwired May 1, 2013) International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell based therapies announced that Dr. Ruslan Semechkin, VP of Research and Development, will present additional data from the primate study of the use of neuronal cells for the treatment of Parkinsons disease at the 16th Annual Meeting of American Society of Gene and Cell Therapy, May 15-18, 2013 at the Salt Palace Convention Center in Salt Lake City, UT.

The results, including more detailed analysis of the safety and functional activity of the cells, will be presented orally at the following session:

Session: Stem Cell Engineering and Therapy Date: Thursday, May 16, 2013 Time: 2:00 PM Room: Ballroom D Title: Cell Replacement Therapy for Parkinsons Disease with Neuronal Cells Derived from Human Parthenogenetic Stem Cells

In addition ISCO will present two posters detailing progress in our pre-clinical metabolic liver disease program and recent achievements with our safe iPS cells, induced pluripotent stem cells that do not rely on viral vectors for the genetic reprogramming. The posters will be presented on Thursday, May 16, 2013 between 4:00 pm and 6:00 pm in Exhibit Hall C/D.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCOs core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com.

To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: http://www.facebook.com/InternationalStemCellCorporation and http://www.twitter.com/intlstemcell

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ViaCord® to Advance Cord Blood Stem Cell Therapy Research …

WALTHAM, Mass.(BUSINESS WIRE)

ViaCord, PerkinElmers family cord blood and tissue preservation business, is collaborating with the Center for International Blood and Marrow Transplant Research (CIBMTR) to collect, maintain and publish research from ViaCords cord blood stem cell transplants. This collaboration will expand knowledge of cord blood-derived stem cell applications throughout the medical and research community. To date, CIBMTRs large network of transplant centers has resulted in the development of a clinical database of more than 30,000 cord blood transplant recipients for clinical decision-making, use in studies, and other research purposes with the goal of making a profound impact on the survival of cord blood transplant patients around the world. CIBMTR will work directly with ViaCord to collect and analyze data to better understand the quality and any outcome metrics of ViaCords released cord blood stem cell units as well as how the units are being used.

Collaborating with CIBMTR, which has established the industry standard for collecting data around hematopoietic cellular therapy and regenerative medicine, allows us to simultaneously gain insights into the effectiveness of the cord blood stem cell units we have released for use as well as outcomes from their clinical application, said Morey Kraus, Chief Scientific Officer, ViaCord. We are then able to incorporate data from our transplanted units into the larger database, which may be accessed for other CIBMTR studies by the medical and scientific community to further their research and understanding of cord blood stem cells.

ViaCord is working with CIBMTR to collect and publish data as well as identify outcomes unique to related or autologous (stem cells from the same patient) transplants. The collaboration will also enable the analysis of umbilical cord units released for potential future use in autologous cell therapy and regenerative medicine clinical trials, including Cerebral Palsy, Type 1 Diabetes and others.

The science of cord blood and cord tissue stem cells is growing at a rapid pace, said J. Douglas Rizzo, M.D., M.S., Associate Scientific Director, CIBMTR. We are excited to collaborate with ViaCord to provide data and analytic expertise that will assist the development of the field through research.

ViaCords family cord blood banking services currently offers expectant families the opportunity to preserve their babys umbilical cord blood for potential medical use by the child or a related family member. Families are also preserving their babys umbilical cord tissue because research suggests that one day these special cells may have the potential to treat medical conditions that are untreatable today. ViaCord has preserved the umbilical cord blood of more than 300,000 newborns. Twenty years ago, cord blood stem cells were used to treat just one disease, Fanconis anemia. Today, cord blood stem cells have been used in the treatment of nearly 80 diseases, including cancers, certain blood disorders and immunodeficiencies. Please visit http://www.viacord.com for more information.

Factors Affecting Future Performance This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities and divestitures. Words such as believes, intends, anticipates, plans, expects, projects, forecasts, will and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on managements current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) fluctuations in the global economic and political environments; (3) our failure to introduce new products in a timely manner; (4) our ability to execute acquisitions and license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (5) our failure to adequately protect our intellectual property; (6) the loss of any of our licenses or licensed rights; (7) our ability to compete effectively; (8) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (9) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (10) disruptions in the supply of raw materials and supplies; (11) the manufacture and sale of products exposing us to product liability claims; (12) our failure to maintain compliance with applicable government regulations; (13) regulatory changes; (14) our failure to comply with healthcare industry regulations; (15) economic, political and other risks associated with foreign operations; (16) our ability to retain key personnel; (17) significant disruption in our information technology systems; (18) our ability to obtain future financing; (19) restrictions in our credit agreements; (20) our ability to realize the full value of our intangible assets; (21) significant fluctuations in our stock price; (22) reduction or elimination of dividends on our common stock; and (23) other factors which we describe under the caption Risk Factors in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

About the Center for International Blood and Marrow Transplant Research(CIBMTR) A combined research program of the National Marrow Donor Program and the Medical College of Wisconsin, the CIBMTR facilitates critical, cutting-edge research that has led to increased survival and an enriched quality of life for thousands of patients. The CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation and cellular therapy research worldwide. The prospective and observational research is accomplished through scientific and statistical expertise, a large network of transplant centers and clinical database of more than 350,000 transplant recipients.

About PerkinElmer, Inc. PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The company reported revenue of approximately $2.1 billion in 2012, has about 7,500 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at http://www.perkinelmer.com.

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ViaCord® to Advance Cord Blood Stem Cell Therapy Research ...

Girl gets stem cell windpipe in historic operation

A two-year-old girl born without a windpipe now has a new one grown from her own stem cells, making her the youngest patient in the world to benefit from the experimental treatment.

Hannah Warren has been unable to breathe, eat, drink or swallow on her own since she was born in South Korea in 2010. Until the operation at a U.S. hospital, she had spent her entire life in a hospital in Seoul. Doctors there told her parents there was no hope and they expected her to die.

The stem cells came from Hannah's bone marrow, extracted with a special needle inserted into her hip bone. They were seeded in a lab onto a plastic scaffold, where it took less than a week for them to multiply and create a new windpipe.

The windpipe was implanted April 9 in a nine-hour procedure.

Early signs indicate the windpipe is working, Hannah's doctors announced Tuesday, although she is still on a ventilator. They believe she will eventually be able to live at home and lead a normal life.

"We feel like she's reborn," said Hannah's father, Darryl Warren.

"They hope that she can do everything that a normal child can do but it's going to take time. This is a brand new road that all of us are on," he said in a telephone interview. "This is her only chance but she's got a fantastic one and an unbelievable one."

Warren choked up and his wife, Lee Young-mi, was teary-eyed at a hospital news conference Tuesday. Hannah did not attend because she is still recovering from the surgery. She developed an infection after the operation but now is acting like a healthy 2-year-old, her doctors said.

Warren said he hopes the family can bring Hannah home for the first time in a month or so. Hannah turns 3 in August.

"It's going to be amazing for us to finally be together as a family of four," he said. The couple has an older daughter.

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Girl gets stem cell windpipe in historic operation

International Stem Cell Corporation to Present at American Society of Gene and Cell Therapy 16th Annual Meeting

CARLSBAD, CA--(Marketwired - May 1, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell based therapies announced that Dr. Ruslan Semechkin, VP of Research and Development, will present additional data from the primate study of the use of neuronal cells for the treatment of Parkinson's disease at the 16th Annual Meeting of American Society of Gene and Cell Therapy, May 15-18, 2013 at the Salt Palace Convention Center in Salt Lake City, UT.

The results, including more detailed analysis of the safety and functional activity of the cells, will be presented orally at the following session:

Session: Stem Cell Engineering and Therapy Date: Thursday, May 16, 2013 Time: 2:00 PM Room: Ballroom D Title: Cell Replacement Therapy for Parkinson's Disease with Neuronal Cells Derived from Human Parthenogenetic Stem Cells

In addition ISCO will present two posters detailing progress in our pre-clinical metabolic liver disease program and recent achievements with our "safe" iPS cells, induced pluripotent stem cells that do not rely on viral vectors for the genetic reprogramming. The posters will be presented on Thursday, May 16, 2013 between 4:00 pm and 6:00 pm in Exhibit Hall C/D.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com.

To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: http://www.facebook.com/InternationalStemCellCorporation and http://www.twitter.com/intlstemcell

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International Stem Cell Corporation to Present at American Society of Gene and Cell Therapy 16th Annual Meeting

NeoStem’s Subsidiary, Progenitor Cell Therapy … – Stem Cell Cafe

ALLENDALE, N.J., April 29, 2013 (GLOBE NEWSWIRE) NeoStem, Inc. (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy LLC (PCT), announced today the execution of a Services Agreement with Sentien Biotechnologies, Inc. (Sentien) under which PCT will provide services to support Sentiens development of its cell therapy product, including technology transfer, staff training, and manufacturing.

Sentien is developing an allogeneic cell therapy product consisting of bone marrow derived mesenchymal stem cells seeded onto a medical device for critical care indications. Sentien has engaged PCT for manufacture of the final formulation of its cell therapy product and intends to transfer and implement Sentiens master cell bank, product working cell bank and product manufacturing processes to PCT. These cell banks will be prepared according to Good Manufacturing Practices (GMP) guidelines and implemented by PCT to create a cell therapy product for Sentiens Investigational New Drug (IND) submission to the FDA. Upon obtaining an IND, Sentien intends to have PCT manufacture GMP compliant grade materials to support Sentiens Phase I clinical trial.

We are excited to enter into this agreement with Sentien, an innovator for acute organ failure, said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. PCT is an internationally recognized contract development and manufacturing organization with facilities in Allendale, New Jersey and Mountain View, California. The company has expertise in GMP manufacture for cell therapies, including dendritic cells, stem cells and T cells. Notably, PCT provided manufacturing for the pivotal studies for Dendreons Provenge(R), the first cell therapy approved for cancer treatment.

About NeoStem, Inc.

NeoStem, Inc. (NeoStem or the Company) is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization (CDMO) providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation. http://www.neostem.com

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect managements current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Companys business strategy, including with respect to the Companys research and development and clinical evaluation efforts for cellular therapies, including with respect to AMR-001, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the Companys ability to successfully grow its contract development and manufacturing business. The Companys actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the Risk Factors described in the Companys Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2013 and in the Companys periodic filings with the Securities and Exchange Commission. The Companys further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem's Subsidiary, Progenitor Cell Therapy ... - Stem Cell Cafe

Clarifying the effect of stem cell therapy on cancer – Stem Cell Cafe

Public release date: 28-Apr-2013 [ | E-mail | Share ]

Contact: Hilary Glover hilary.glover@biomedcentral.com 44-020-319-22370 BioMed Central

Injection of human stem cells into mice with tumors slowed down tumor growth, finds research published in BioMed Centrals open access journal Stem Cell Research & Therapy. Human mesenchymal stem cells (MSC), isolated from bone marrow, caused changes in blood vessels supplying the tumor, and it is this modification of blood supply which seems to impact tumor growth.

The use of stem cells in treating cancer has been controversial, with some studies finding that stem cells force tumors to enter programmed cell death. However other studies find that stem cells actually promote tumor growth by inducing infiltration of new blood vessels. In attempting to sort out this puzzle researchers from INSERM groups at Universit Joseph Fourier in collaboration with CHU de Grenoble investigated the impact of MSC on already established subcutaneous or lung metastasis in mice.

For both the subcutaneous and lung tumors, injection of MSC reduced cell division, consequently slowing the rate of tumor growth. Part of the mode of action of stem cells therefore appears to be due to with angiogenesis, but the mechanism behind this is still unclear.

Claire Rome who led this study explained, We found that MSC altered vasculature inside the tumor although new blood vessels were generated, overall they were longer and fewer than in untreated tumors. This could be restricting the oxygen and nutrients to the tumor, limiting cell division. She continued, Our study confirms others which propose that stem cells, in particular MSC, might be one way forwards in treating cancer.

Commenting on this study Celia Gomes, from the University of Coimbra, said, One of the interesting questions this study raises is when MSC promote tumor growth and when they restrict it. The answer seems to be timing this study looks at already established tumors, while others, which find that MSC increase growth, tend to be investigating new tumors. This is a first step in the path to identifying exactly which patients might benefit from stem cell therapy and who will not.

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Dr Hilary Glover Scientific Press Officer, BioMed Central Tel: +44 (0) 20 3192 2370 Mob: +44 (0) 778 698 1967 Email: hilary.glover@biomedcentral.com

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