Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone

SAN DIEGO, CA--(Marketwire -06/04/12)- Medistem Inc. (MEDS) announced today positive safety data from the first 5 patients enrolled in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The clinical trial uses the company's "Universal Donor" Endometrial Regenerative Cells (ERC) to treat Congestive Heart Failure (CHF).

According to the study design, after 5 patients enter the trial, they must be observed for a two month time period before additional patients are allowed to enter the study. Patient data was analyzed by the study's independent Data Safety Monitoring Board (DSMB), which concluded that based on lack of adverse effects, the study be allowed to continue recruitment.

"Medistem is developing a treatment for CHF that uses a 30-minute catheter-based procedure to administer the ERC stem cell into the patients' hearts. The achievement of 2 month patient follow-up with no adverse events is a strong signal for us that our new approach to this terrible condition is feasible," said Thomas Ichim, CEO of Medistem.

The RECOVER-ERC trial will treat a total of 60 patients with end-stage heart failure with three concentrations of ERC stem cells or placebo. The clinical trial is being conducted by Dr. Leo Bockeria, Chairman of the Backulev Centre for Cardiovascular Surgery, in collaboration with Dr. Amit Patel, Director of Clinical Regenerative Medicine at University of Utah.

"As a professional drug developer, I am very optimistic of a stem cell product that can be used as a drug. The ERC stem cell can be stored frozen indefinitely, does not need matching with donors, and can be injected in a simple 30-minute procedure into the heart," said Dr. Sergey Sablin, Vice President of Medistem and co-founder of the multi-billion dollar NASDAQ company Medivation.

Currently patients with end-stage heart failure, such as the ones enrolled in the RECOVER-ERC study, have no option except for heart transplantation, which is limited by side effects and lack of donors. In contrast to other stem cells, ERC can be manufactured inexpensively, do not require tissue matching, and can be administered in a minimally-invasive manner. Animal experiments suggest ERC are more potent than other stem cell sources at restoring heart function. The FDA has approved a clinical trial of ERC in treatment of critical limb ischemia in the USA.

About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone

Stem cell therapy for cornea treatment

Hyderabad, June 2:

Picking stem cells from a patients body, sending it to a sophisticated laboratory to culture a tissue and then implanting it are pass.

A team of doctors at L.V. Prasad Eye Institute has used the tea bag or sprinkler approach to regenerate stem cells. The organisation has developed a lab-free technique that could be available off-the-shelf. This allows eye surgeons with usual facilities to perform the procedure.

The team, led by Dr Virender Singh Sangwan, used this technique to treat those who suffered chemical injuries, resulting in bleeding in the cornea.

Instead of sending stem cells to the lab for culture, the doctor picked the required number of stem cells around the cornea and sprinkled on the damaged area and then put a contact lens. In 15 days, he sees development of a good layer in the place of injured area, Prof. Balasubramanian, Head of Research at LVPEI, said.

A winner of the prestigious Shanti Swarup Bhatnagar prize, Dr Sangwan said he had conducted the procedure on about 25 patients with good results. This had been published in international scientific magazines.

He is now in the process of developing tools to help doctors.

Leber Congenital Amaurosis

Children down with the rare ocular disorders that result in gradual loss of sight can hope for a cure. Doctors are working on a gene therapy to correct this problem caused by consanguineous marriages.

Though this therapy is in vogue abroad, LVPEI says it is the first centre to carry out research on this procedure. Technically called LCA or Leber Congenital Amaurosis, doctors would refer patients to a gene analysis after studying them for indications.

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30-05-2012 10:07

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29 Johns Hopkins stem cell researchers awarded funding

Public release date: 30-May-2012 [ | E-mail | Share ]

Contact: Vanessa McMains vmcmain1@jhmi.edu 410-502-9410 Johns Hopkins Medical Institutions

This year the Maryland Stem Cell Research Fund awarded 29 of 40 grants to Johns Hopkins researchers for the study of stem cell metabolism and regulation, the creation of new cell models for human diseases such as schizophrenia and Rett syndrome, which previously could be studied only in animals, and the development of new potential therapies.

Researchers whose preliminary data promised greater discoveries were awarded Investigator-Initiated grants. Jeff Bulte, Ph.D., professor of radiology, biomedical engineering and chemical and biomolecular engineering and a member of the Institute for Cell Engineering, hopes to develop a cell therapy for treatment of type 1 diabetes an autoimmune disorder in which the immune system kills the insulin-producing cells that help regulate blood sugar. By developing cloaked stem and insulin-producing cells that can evade immune system detection, Bulte and his team hope to replace damaged cells and restore insulin levels in patients.

Grants were awarded to:

Several Johns Hopkins investigators were awarded Exploratory grants for researchers either new to the stem cell field or with untested but promising new ideas. Miroslaw Janowski , M.D., Ph.D., a research associate in radiology, plans to develop a stroke treatment by guiding newly introduced brain cells with magnets through blood vessels to the site of injury.

Exploratory grants were awarded to:

Postdoctoral trainees also will receive funding for research projects. A fellow in biomedical engineering, Pinar Huri, Ph.D., will use her award to develop bone grafts with blood vessels inside made from fat tissue-derived stem cells. The grafts would be used in patients with severely damaged bone in need of reconstructive surgery.

Postdoctoral grants were awarded to:

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29 Johns Hopkins stem cell researchers awarded funding

Gaborone could have stem cell storage facility this year

Gaborone could have stem cell storage facility this year

LAWRENCE SERETSE Correspondent

Speaking to Mmegi this week, Mngqibisa said Parliament was set to pave the way for the facility by means of legislation in July and that Cryo-Save intended approaching government about storing stem cells for every Motswana.

"Stem cells are the basic building blocks of our bodies and are often referred to as 'master cells,'" she said.

"And because stem cells have the potential to become almost any other cell in the body, stem cell therapies are the way of the future."

Stem cell treatment is applied to over 70 diseases and disorders, among them leukemia, lymphoma, blood cancers and bone marrow disorders like aplastic anaemia and sickle cell disease.

Mngqibisa said patients requiring a haemopoietic stem transplant will receive cells from one or three sources of bone marrow, circulating blood or umbilical cord blood.

"It is much easier to match transplant patients with immune naive cord blood stem cells than with the other sources of stem cells," she explained. "Umbilical cord blood stem cells are the most naive stem cells, hence they are best harvested from the baby at birth before they are exposed to infections and immune reactions."

She said transplant patients recovered better when they received stem cells from a related donor rather than from an unrelated donor. Brain tumors, lung cancer, plasma cell leukemia, anaemia and osteopetrosis.

Multiple sclerosis and diabetes can also help in tissue building like skin burn repairs. The newborn may be able to use his or her cord blood for some of the conditions on a long list, but not all. In some cases, a matching sibling stem cell would be the first choice.

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Gaborone could have stem cell storage facility this year

UCI researcher wins large research grant

A UC Irvine stem cell researcher won a $4.8-million grant to fund research toward a treatment for multiple sclerosis.

The California Institute for Regenerative Medicine awarded immunologist Thomas Lane, of the campus' Sue and Bill Gross Stem Cell Research Center, an Early Transitional Award last week to create a new line of neural stem cells to treat multiple sclerosis, according to a UCI press release.

"I am delighted that [the California Institute] has chosen to support our efforts to advance a novel stem cell-based therapy for multiple sclerosis," Peter Donovan, director of the research center, said in the release.

Lane is collaborating with Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, and Claude Bernard, a multiple sclerosis researcher at Monash University in Australia.

The research project "really embodies what [the California Institute] is all about, which is bringing science together to treat horrible diseases like multiple sclerosis," said Lane, who is a professor of molecular biology and biochemistry.

Multiple sclerosis is a central nervous system disease that causes inflammation and a loss of myelin, a fatty tissue that insulates and protects nerve cells.

The three are working on a stem cell treatment that will stop myelin loss while promoting the growth of new myelin to mend damaged nerves.

Loring creates the neural stem cells, said Lane, while he is testing the therapeutic effects the cells have on multiple sclerosis cells in animals.

The stem cells are already having a positive effect and the scientists are trying to understand why. They hope to identify the cells that have the most promise before going to clinical trials.

"I really want to thank the [California Institute] for allowing, and for funding, us," Lane said.

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UCI researcher wins large research grant

Actium Research and McMaster University Collaborate to Commercialize Stem Cell Technologies

Arrangement pairs one of Canada's most successful biotech executive teams with academic discovery engine to address the need for better drugs targeting cancer stem cells and regenerative medicine.

TORONTO/HAMILTON, May 29, 2012 /CNW/ - Actium Research Inc., ("Actium" or the "Company") Toronto, and McMaster University ("McMaster"), Hamilton, have entered into a landmark collaboration covering McMaster's proprietary adult human stem cell lines, cancer stem cells and the directed differentiation platform developed by Dr. Mick Bhatia and his team at the McMaster Stem Cell and Cancer Research Institute ("The Stem Cell Institute"). Together these technologies and the expertise at The Stem Cell Institute provide leading edge tools for drug discovery and better treatments for serious illnesses.

Actium is a drug discovery and development company targeting two types of stem cells; cancer stem cells to improve survival and health outcomes and normal tissue stem cells to promote healing and address the need for cure in chronic diseases. Actium was founded by Dr. David Young and Helen Findlay. Dr. Bhatia joined as the scientific founder in 2012. The team will put their experience with managing drug discovery platforms, development pathways and product pipelines to work to build Actium into a leading biotech company.

Previously, Dr. David Young and Ms Helen Findlay were uniquely successful in creating ARIUS Research Inc. ("ARIUS"), a public biotech company, trading on the TSX, specializing in the discovery and development of therapeutic cancer antibodies based entirely on technology developed in its own research labs. ARIUS' FunctionFIRST technology was partnered with leading companies such as Takeda Pharmaceuticals, Japan's largest drug company, Genentech, the leader in cancer antibodies, and Protein Design Labs, a pioneer in antibody humanization. These and other partnerships represented over $400 million of value. ARIUS was a singular financial success story in Canada. The sale of the company to Roche in 2008 generated a five times return on capital, cash on cash, representing the largest return to date for investors in a Canadian biotech company. More importantly, the company created the first specific cancer stem cell drug to enter human clinical trials. The company was well recognized for its accomplishments: it was named as a top 50 company by the TSX Venture Exchange in 2005, a top 10 company by Ottawa Life Sciences Council in 2006, and Biotech Company of the Year by BioteCanada in 2009.

"After we founded Actium we were presented with many interesting technologies looking for commercialization support." said David Young, Actium CEO. "Ontario has a wealth of great researchers and I think with Dr. Mick Bhatia's leadership and the support from the community, the Stem Cell Institute at McMaster stands at the forefront. Much has been written about Canada's commercialization gap and desperate need to move our research from the bench into the clinic so that we benefit from medical innovation both as patients and as a society. The federal government placed a lot of emphasis on addressing this gap in the most recent budget and our agreement with McMaster represents a great example of academia working with the private sector to achieve these goals. Actium is pleased to join the other companies and groups working to see Ontario's medical research advanced to provide our physicians with new tools to achieve better outcomes."

McMaster University is committed to creating collaborations that help accelerate the pace intellectual property is transferred from its labs and to the marketplace, where it will have the greatest impact.

"This specific initiative will assist us in doing just that," said Mo Elbestawi, McMaster Vice-President, Research and International Affairs. "These discoveries from Dr. Bhatia's lab show great promise and we're delighted with his efforts to commercialize the results of his research, from which many will benefit."

Initially, Actium will develop anti-cancer stem cell drugs that are directed against a newly identified cancer stem cell marker in leukemia and breast cancer. Cancer stem cells are a unique group of cells within a tumor that do not respond to conventional therapies and may be responsible for cancers that spread or that return after treatment. The company will also work through research agreements with McMaster and The Stem Cell Institute to identify drugs that cause "normal" stem cells to become specialized as different tissue types to promote healing. In addition, the Actium strategy includes accessing technologies that expand drug development capabilities or fill pipeline gaps. The overall development strategy is guided by principles of pipeline management where projects compete with each other for resources, and allocations are made according to success-based performance metrics. "This is the most efficient way to allocate resources to the compounds with the best chances of becoming breakthrough drugs. In this horse race the winners go on to the next race until a champion is crowned", said Dr. Bhatia, Actium Chief Scientific Officer.

About McMaster University and the McMaster Industry Liaison Office

McMaster University, one of four Canadian universities listed among the Top 100 universities in the world, is renowned for its innovation in both learning and discovery. With a research income of more than $395 million, McMaster ranks second in research intensity among Canadian universities. It is home to more than 23,000 students, 1,300 faculty members, and 70 world-class research centres and institutes. Through the McMaster Industry Liaison Office, the University facilitates the commercialization efforts of its faculty by connecting them to the marketplace.

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Actium Research and McMaster University Collaborate to Commercialize Stem Cell Technologies

Bioheart and Ageless Regenerative Partner to Advance Stem Cell Field With New Laboratory Training Program on June 23 …

SUNRISE, Fla., May 29, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (OTCBB:BHRT.OB - News) announced today that it will offer another laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine, on Saturday/Sunday June 23-24, 2012. Attendees will participate in hands on, in depth training in laboratory practices in stem cell science at Bioheart, Inc.'s corporate headquarters and clean room in Sunrise, Florida. The course was designed for Laboratory technicians, Students, Physicians and Physician Assistants.

"Attendees will graduate from this one-of-a-kind course with an extensive understanding of stem cell science laboratory practices," said Kristin Comella, Chief Scientific Officer, Bioheart, Inc. "Previous attendees described the course as incredibly well orchestrated providing comprehensive know how for laboratory start up."

An emerging field with tremendous opportunities, adult stem cell research has been shown to regenerate and repair injured or diseased structures via the release of bioactive tissue growth factors and cytokines. This is the second time that The Ageless Regenerative Institute has partnered with Bioheart, Inc. to provide hands-on training in a stem cell laboratory. This course provides instruction regarding how to grow stem cells and perform quality control testing in an actual cGMP facility following FDA regulations.

The course goals and objectives include reviewing stem cell types and characteristics; learning cell culture including plating, trypsinization and harvesting, and cryopreservation; learning quality control tests including cell count, viability, flow cytometry, endotoxin, mycoplasma, sterility; and learning and performing cGMP functions including clean room maintenance, gowning and environmental monitoring.

For information on costs and to register, visit http://www.agelessregen.com or email: 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.

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 and Ageless Regenerative Partner to Advance Stem Cell Field With New Laboratory Training Program on June 23 ...

CHOC Children’s Research Project Awarded $5.5 Million Grant from the California Institute for Regenerative Medicine

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

A CHOC Childrens research project, under the direction of Philip H. Schwartz, Ph.D., senior scientist at the CHOC Childrens Research Institute and managing director of the facilitys National Human Neural Stem Cell Resource, has been awarded a $5.5 million grant from the California Institute for Regenerative Medicine (CIRM). The grant will be used to develop a stem cell-based therapy for the treatment of mucopolysaccharidosis (MPS I), a fatal metabolic disease that causes neurodegeneration, as well as defects in other major organ systems.

Based on a number of medical and experimental observations, children with inherited degenerative diseases of the brain are expected to be among the first to benefit from novel approaches based on stem cell therapy (SCT).

Dr. Schwartz explains, While uncommon, pediatric genetic neurodegenerative diseases account for a large burden of mortality and morbidity in young children. Hematopoietic (bone marrow) stem cell transplant (HSCT) can improve some non-neural symptoms of these diseases, but does not treat the deadly neurodegenerative process. Our approach targeting the effects of the disease on organs besides the brain with HSCT and neurodegeneration with a second stem cell therapy specifically designed to treat the brain is a strategy for whole-body treatment of MPS I. Our approach is also designed to avoid the need for immunosuppressive drugs to prevent rejection of the transplanted cells.

This research is designed to lead to experimental therapy, based on stem cells, by addressing two critical issues: early intervention is required and possible in this patient population; and teaching the immune system not to reject the transplanted cells is required. This research also sets the stage for efficient translation of this technology into clinical practice, by adapting transplant techniques that are standard in clinical practice or in clinical trials, and using laboratory cell biology methods that are easily transferrable to clinical cell manufacturing.

Nationally recognized for his work in the stem cell field, Dr. Schwartz research focuses on the use of stem cells to understand the neurobiological causes of autism and other neurodevelopmental disorders.

Named one of the best childrens hospitals by U.S. News & World Report (2011-2012) and a 2011 Leapfrog Top Hospital, CHOC Children's is exclusively committed to the health and well-being of children through clinical expertise, advocacy, outreach and research that brings advanced treatment to pediatric patients.

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CHOC Children’s Research Project Awarded $5.5 Million Grant from the California Institute for Regenerative Medicine

Makati Medical Center now offering stem cell therapy

THE MAKATI Medical Centers Cancer Center celebrated its first year anniversary and marked the occasion with the launch of its Cellular Therapeutics Laboratory. Present at the ribbon-cutting ceremony were Dr. Eric Flores, head, Spine Clinic and Stem Cell Lab; Rosalie Montenegro, Makati Medical Center president and CEO; Dr. ManuelO. Fernandez Jr., executive vice president and director, Professional Services; Dr. Remedios G. Suntay, director and treasurer, MDI Board; Dr. Benjamin N. Alimurung, medical director; Dr. Francis Chung, scientific officer, Stem Cell Lab; and Augusto P. Palisoc Jr., executive director, president and CEO, MPIC Hospital Group.

MAKATIMEDS Cellular Therapeutics Laboratory is managed by experienced scientists with extensive training and is affiliated with the International Society for Cellular Therapy.

Stem cell therapy is now being offered at Makati Medical Center (MMC) as potential cure for a wide range of illnesses, from various types of cancer and heart ailments to incurable diseases such as multiple sclerosis, Parkinsons and Alzheimers.

Stem cell therapy is believed to be effective in bone marrow transplant for leukemia patients, and with early intervention, yields desirable results among renal and prostate cancer patients.

Launched in the first year anniversary of the hospitals cancer center, MMCs Cellular Therapeutics Laboratory is equipped with technology touted to be totally unmatched in our country, says Dr. Francis Chung, scientific officer of the lab. No system exists elsewhere.

Employing the strictest sterility standards at par with that of the US Food and Drug Administration, the lab has state-of-the-art facilities. The Clinimacs CD34 Reagent System is a machine that isolates specific cells needed for the procedure, while the Flow Cytomer ensures the purity of cultured cells.

Transplantation

Sourcing the stem cells, however, is what truly sets the Philippines premier health institution apart from chi-chi spas that also push stem cell therapy for beauty and anti-aging procedures.

At MMC, healthy stem cells are acquired from the patients themselves, a process known as autologous transplantation. For those suffering from an ailment, a parent, sibling or other close relative could be the donor. The hospital strives for utmost compatibility between patient and donor through a 10-point DNA matching system.

If a battery of tests finds a patient to be up to it, medication is given to prepare him for stem cell harvest.

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Makati Medical Center now offering stem cell therapy