Stem Cell Clinic

Cell therapy: New mouse model promises to advance research on induced pluripotent stem cells

Feb. 21, 2013 Cell therapy is a promising alternative to tissue and organ transplantation for diseases that are caused by death or poor functioning of cells. Considering the ethical discussions surrounding human embryonic stem cells, a lot is expected of the so-called 'induced pluripotent stem cells' (iPS cells). However, before this technique can be applied effectively, a lot of research is required into the safety and efficacy of such iPS cells. VIB scientists associated to the UGent have developed a mouse model that can advance this research to the next step.

Lieven Haenebalcke (VIB/UGent): "iPS cells have enormous therapeutic potential, but require more thorough testing before they can be used for such purposes. Using our new mouse model, we can study which mechanisms determine the identity of a cell. This knowledge is essential before we can use cell therapy for regenerative medicine."

Jody Haigh (VIB/UGent): "If we want to give cell therapy a future, then we must continue this type of research and invest in the further development of such technologies. This will result in an improved insight into cellular identity and -- in the long term -- safer options of applying iPS cells or cells derived from iPS cells in clinical studies."

Cell therapy -- replacing cells to provide a cure

Cell therapy is the replacement of lost or poorly functioning cells in patients. For example, such cell therapies could be used to repair the heart muscle after a heart attack, joints affected by arthritis, the pancreas in diabetes or the spine in certain forms of paralysis. This requires cells that are able to multiply in the laboratory and that can be converted to healthy cells of the desired cell type. Human embryonic stem cells meet these criteria, but they are ethically controversial.

iPS cells -- a promising alternative to embryonic stem cells

Shinya Yamanaka recently developed a fairly simple method to reprogram differentiated cells -- such as skin cells -- back to stem cells, so-called "induced pluripotent stem cells" (iPS cells). This earned him the Nobel Prize for Medicine in 2012 (shared with John Gurdon). These iPS cells can be generated using only 4 "reprogramming factors."

As is the case with embryonic stem cells, these iPS cells can be used to produce other cell types, such as heart muscle cells or nerve cells. They can also be cultured indefinitely and there are no ethical objections as they are not obtained from human embryos left over after IVF, but from adult individuals. Furthermore, iPS cells are obtained from the patient and this reduces the risk of rejection during therapeutic applications.

Essential research possible

Before iPS cells can be used effectively and safely as a therapy, it is essential that we gain clear insight into which molecular mechanisms determine the identity of a cell; why and how a cell develops into -- for example -- a heart muscle cell, a nerve cell or a blood cell. In order to do so, Lieven Haenebalcke and Jody Haigh have developed a mouse model that will enable them to conduct this research. They succeeded in creating iPS cells from a variety of mouse cells. Furthermore, the new model allows the investigators to replace the 4 reprogramming factors in these iPS cells efficiently with specific genes in order to create targeted different cell types, such as functional heart muscle cells.

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Cell therapy: New mouse model promises to advance research on induced pluripotent stem cells

Cellular Biomedicine Group President Presents Keynote Address at New York Stem Cell Summit

NEW YORK, Feb. 22, 2013 /PRNewswire/ --Dr Wei William Cao, PhD, BM, President of Cellular Biomedicine Group presented a keynote address at the 8th annual New York Stem Cell Summit on February 19, 2013. Dr Cao discussed the current government regulations and support of cellular medicine research and development in China.

The New York Stem Cell Summit featured more than 30 of the world's leaders in the stem cell industry, bringing the future of this dynamic industry to life for investors, industry, practitioners, and analysts. The presentations and networking provided insight into investment opportunities in the stem cell marketplace, groundbreaking stem cell products that physicians use today, and the growing market potential.

Dr Cao served as Technical Manager for Bayer Diagnostics Asia Pacific region, General Manager of GenoMultix Ltd., President of Wuxi New District Hospital, and China General Manager of Affymetrix, a world leader in genetic analysis industry. Dr Cao has extensive research experience in immunopharmacology at Harvard Medical School and Stanford Medical School. He holds a Guest Professorship at the Department of Histology and Embryology of Fudan University Medical School, Shanghai China. Dr Cao earned a Bachelor's degree in Medicine from Fudan University Medical School, Shanghai China, and PhD degree in immunopharmacology from Medical College of Virginia, Richmond Virginia. He is an inventor of 24 patents in the field of genetic analysis and stem cell technology, especially adipose derived stem cell preparation and its disease treatment applications.

About Cellular Biomedicine GroupCellular Biomedicine Group, Ltd. develops proprietary cell therapies for the treatment of certain degenerative diseases. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility, consisting of eight independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: http://www.cellbiomedgroup.com

Forward-Looking Statements

Statements in this press release relating to plans, strategies, economic performance and trends, projections of results of specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "should," "could," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "forecasts," "potential," or "continue," or similar terms or the negative of these terms. 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. The Company has no obligation to update these forward-looking statements.

CONTACT:

Jeff Ramson Investor Relations ProActive Capital Group 646-863-6341

Sarah Kelly Director of Corporate Communications (+86) 21 54069990 sarah.kelly@cellbiomedgroup.com

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Cellular Biomedicine Group President Presents Keynote Address at New York Stem Cell Summit

Stem cell 'homing' signal may help treat heart failure patients

Feb. 21, 2013 In the first human study of its kind, researchers activated heart failure patients' stem cells with gene therapy to improve their symptoms, heart function and quality of life, according to a study in the American Heart Association journal Circulation Research.

Researchers delivered a gene that encodes a factor called SDF-1 to activate stem cells like a "homing" signal.

The study is unique because researchers introduced the "homing" factor to draw stem cells to the site of injury and enhance the body's stem cell-based repair process. Generally, researchers extract and expand the number of cells, then deliver them back to the subject.

"We believe stem cells are always trying to repair tissue, but they don't do it well -- not because we lack stem cells but, rather, the signals that regulate our stem cells are impaired," said Marc S. Penn, M.D., Ph.D., Director of Research at Summa Cardiovascular Institute in Akron, Ohio, and lead author and professor of medicine at Northeast Ohio Medical University in Rootstown, Ohio.

SDF-1 is a naturally occurring protein, secreted by cells, that guides the movement of other cells. Previous research by Penn and colleagues has shown SDF-1 activates and recruits the body's stem cells, allowing them to heal damaged tissue. However, the effect may be short-lived. For example, SDF-1 that's naturally expressed after a heart attack lasts only a week.

In the study, researchers attempted to re-establish and extend the time that SDF-1 could stimulate patients' stem cells. Study participants' average age was 66 years.

Researchers injected one of three doses of the SDF-1 gene (5mg, 15mg or 30mg) into the hearts of 17 patients with symptomatic heart failure and monitored them for up to a year. Four months after treatment, they found:

"We found 50 percent of patients receiving the two highest doses still had positive effects one year after treatment with their heart failure classification improving by at least one level," Penn said. "They still had evidence of damage, but they functioned better and were feeling better."

The findings indicate people's stem cells have the potential to induce healing without having to be taken out of the body, Penn said.

"Our study also shows gene therapy has the potential to help people heal their own hearts."

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Stem cell 'homing' signal may help treat heart failure patients

REPEAT: Stem Cell Therapeutics Announces Joint-Venture Agreement With Reneu Inc. and Nexgen Medical Systems, Inc

TORONTO, ONTARIO--(Marketwire - Feb 20, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) ("SCT" or the "Corporation") a life sciences company developing stem cell-related technologies, today announced a joint-venture agreement with ReNeu Inc. of Calgary, AB, Canada, ("ReNeu") and NexGen Medical Systems, Inc. of Melbourne, FL, USA ("NexGen").

ReNeu is a company formed to commercialize drug-based therapies to treat central nervous system disorders in combination with devices and processes for direct-to-brain administration. Subject to the definitive agreement, SCT and NexGen will license their respective technologies to ReNeu under world-wide,royalty-free licenses for the use of NexGen''s FDA-cleared EViTAR line of proprietary intracranial delivery systems and SCT''s NTx-265, -428 and -488 covering the proprietary use of drugs for the regeneration of endogenous neural stem cells.

To the knowledge of the Corporation the EViTAR intracranial delivery system is the only FDA-cleared Class II medical device currently indicated for the injection of material into the brain during intracranial procedures. It is designed for site-specific, low-volume, high-concentration delivery of drugs to target tissues in the brain of patients suffering from stroke, neurodegenerative disease, and tumors. SCT''s NTx-265 is a therapeutic regimen of approved and clinically well-defined drugs that include human Chorionic Gonadotropin ("hCG") and erythropoietin ("EPO") for the regeneration of neural stem cells in patients following stroke, traumatic brain injury and other neurological conditions.

"ReNeu''s perceptive innovation that the combination of SCT''s award-winning, proprietary discoveries by Dr. Sam Weiss, Director of the Hotchkiss Brain Institute, if administered in a direct-to-brain process, holds the promise of delivering the regenerative results that Dr. Weiss'' discovery originally proposed.NexGen''s EViTAR family would appear to be an ideal vehicle for the clinical expansion of the SCT products and we are enthusiastic about its prospects," said David Allan, Executive Chairman of SCT.

Under the Letter of Agreement SCT will own 50% of the joint-venture for which the definitive agreement is anticipated within 60 days, subject to final due-diligence and usual conditions being met.

"The breakthrough benefit to patients that could be expected to result from a positive clinical demonstration from the combination of these two critical elements for the treatment of neurologically degenerative diseases could be of significant importance for the treatment of patients with stroke and other neurological conditions," said Dr. Joseph Tucker, founding CEO of ReNeu. "The most effective preclinical treatments from Dr. Weiss'' work licensed to SCT were the direct-to-brain approaches, which clearly indicated the prospect of important benefit to patients when developed clinically. At the time, SCT proceeded in its clinical development with systemic rather than site-specific administration because of the absence of availability of a direct-to-brain approach, with the consequence that only limited amounts of SCT''s drug combination reached the brain and equivocal clinical outcomes were achieved. We have high expectations that this fortuitous combination of these two novel approaches could have an importantly different and positive outcome."

"NexGen is very excited about this collaboration with SCT and ReNeu," said John Kucharczyk, CEO of NexGen Medical Systems. "The novel treatment methods have the potential to introduce entirely new therapies for several neurological diseases and disorders. NexGen''s proprietary EViTAR neurocatheters are designed for delivery of therapeutic agents directly to target tissues in the brain and spinal cord, which is expected to significantly reduce side-effects associated with systemic delivery of drugs," Kucharczyk added.

ReNeu''s initial board will be composed of David Allan, Executive Chairman of Stem Cell Therapeutics, Dr. John Kucharczyk, CEO of NexGen Medical Systems, Dr. Brad Thompson, Chairman & CEO of Oncolytics Biotech and Dr. Joseph Tucker, founding CEO of ReNeu. The Company intends to vigorously pursue regulatory approval to move the combined technologies into clinical trials with a target of clinical initiation in 2014.

SCT will retain all rights to its endogenous stem cell-stimulating technology other than direct-to-brain administration.

About Stem Cell Therapeutics Corp.:

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REPEAT: Stem Cell Therapeutics Announces Joint-Venture Agreement With Reneu Inc. and Nexgen Medical Systems, Inc

Osiris Therapeutics Receives Title of European Orphan Drug Designation for Prochymal®

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

Osiris Therapeutics, Inc. (OSIR), the leading stem cell company developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today that the European Medicines Agency (EMA) has designated Osiris as the Orphan Drug title holder for Prochymal (remestemcel-L).

The EU Commission adopted the decision to transfer the designation of Prochymal (ex-vivo cultured adult human mesenchymal stem cells) as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council. The Decision will appear in the EU Community Register of Orphan Medicinal Products.

In Europe, Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, to companies that develop drugs for underserved patient populations.

In the EU, the Orphan Drug designation for Prochymal is for the treatment of acute graft versus host disease (GvHD). Prochymal, a first-in-class allogeneic stem cell therapy, has already received approval in Canada and New Zealand for the treatment of acute GvHD in children, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). Recently, Swissmedic, the Swiss agency responsible for the evaluation of drugs, notified Osiris that Prochymal will be evaluated under its Rapid Authorization Procedure upon submission of the marketing application.

About Prochymal (remestemcel-L)

Prochymal is the worlds first approved drug with a stem cell as its active ingredient. Developed by Osiris Therapeutics, Prochymal is an intravenous formulation of MSCs, which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is approved in Canada and New Zealand for the management of acute GvHD in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in a Phase 3 trial for refractory Crohns disease and in a Phase 2 trial for acute myocardial infarction.

About Osiris Therapeutics

Osiris Therapeutics, Inc., having developed the worlds first approved stem cell drug, Prochymal, is the leading stem cell company. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix for burns and chronic wounds, and Ovation for orthopedic applications. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 50 U.S. and 156 foreign patents.

Osiris, Prochymal, Chondrogen, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIR-G)

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Osiris Therapeutics Receives Title of European Orphan Drug Designation for Prochymal®

Osiris Rises on European Stem-Cell Drug Title Decision

Osiris Therapeutics Inc. rose the most in eight months after European regulators transferred the orphan drug title for a stem cell therapy to the company, making it easier to seek a buyer or partner for the treatment.

Osiris gained 9 percent to $7.65 at the close in New York, its biggest intraday jump since June. The European Medicines Agency made the title transfer for the intravenous treatment Prochymal, which treats a disease that attacks bone marrow- transplant recipients, Columbia, Maryland-based Osiris said in a statement today.

The orphan designation provides 10 years of market exclusivity if the medicine is approved, and the simplifying of who holds the title clears the way for a transaction should Osiris opt to sell Prochymal to another company, said Edward Tenthoff, a senior analyst with Piper Jaffray & Co. in New York.

Theyve started to get approvals for Prochymal, said Tenthoff, who has a neutral rating on the stock. Theres a way for them to monetize that.

Tenthoff said Osiriss former partner, Sanofis Genzyme unit, probably held Prochymals orphan drug title before. Osiris didnt name the previous title holder in its statement.

Osiris had declined 22 percent this year through Feb. 15. An orphan drug typically targets rare diseases and is intended for a small number of patients with few treatment options.

Prochymal is the worlds first approved drug with a stem cell as its active ingredient, Osiris said.

Osiris said in a separate statement it won a patent challenge in Australia. Prochymal is approved in New Zealand and Canada to treat children with acute graft versus host disease, a bone marrow transplant complication that kills as many as 80 percent of children affected. Its the first drug approved to treat the disease, the company said.

The drug is available in seven other countries, including the U.S., under an expanded access program, Osiris said. Such programs make investigational drugs available to treat patients with serious conditions or diseases who cannot participate in a controlled clinical trial.

The company hasnt sought a U.S. Biologics License Application approval yet, which may be what has weighed on the stock this year, Tenthoff said.

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Osiris Rises on European Stem-Cell Drug Title Decision

Stem Cell Therapeutics Announces Joint-Venture Agreement With Reneu Inc. and Nexgen Medical Systems, Inc

TORONTO, ONTARIO--(Marketwire - Feb 19, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) ("SCT" or the "Corporation") a life sciences company developing stem cell-related technologies, today announced a joint-venture agreement with ReNeu Inc. of Calgary, AB, Canada, ("ReNeu") and NexGen Medical Systems, Inc. of Melbourne, FL, USA ("NexGen").

ReNeu is a company formed to commercialize drug-based therapies to treat central nervous system disorders in combination with devices and processes for direct-to-brain administration. Subject to the definitive agreement, SCT and NexGen will license their respective technologies to ReNeu under world-wide,royalty-free licenses for the use of NexGen''s FDA-cleared EViTAR line of proprietary intracranial delivery systems and SCT''s NTx-265, -428 and -488 covering the proprietary use of drugs for the regeneration of endogenous neural stem cells.

To the knowledge of the Corporation the EViTAR intracranial delivery system is the only FDA-cleared Class II medical device currently indicated for the injection of material into the brain during intracranial procedures. It is designed for site-specific, low-volume, high-concentration delivery of drugs to target tissues in the brain of patients suffering from stroke, neurodegenerative disease, and tumors. SCT''s NTx-265 is a therapeutic regimen of approved and clinically well-defined drugs that include human Chorionic Gonadotropin ("hCG") and erythropoietin ("EPO") for the regeneration of neural stem cells in patients following stroke, traumatic brain injury and other neurological conditions.

"ReNeu''s perceptive innovation that the combination of SCT''s award-winning, proprietary discoveries by Dr. Sam Weiss, Director of the Hotchkiss Brain Institute, if administered in a direct-to-brain process, holds the promise of delivering the regenerative results that Dr. Weiss'' discovery originally proposed.NexGen''s EViTAR family would appear to be an ideal vehicle for the clinical expansion of the SCT products and we are enthusiastic about its prospects," said David Allan, Executive Chairman of SCT.

Under the Letter of Agreement SCT will own 50% of the joint-venture for which the definitive agreement is anticipated within 60 days, subject to final due-diligence and usual conditions being met.

"The breakthrough benefit to patients that could be expected to result from a positive clinical demonstration from the combination of these two critical elements for the treatment of neurologically degenerative diseases could be of significant importance for the treatment of patients with stroke and other neurological conditions," said Dr. Joseph Tucker, founding CEO of ReNeu. "The most effective preclinical treatments from Dr. Weiss'' work licensed to SCT were the direct-to-brain approaches, which clearly indicated the prospect of important benefit to patients when developed clinically. At the time, SCT proceeded in its clinical development with systemic rather than site-specific administration because of the absence of availability of a direct-to-brain approach, with the consequence that only limited amounts of SCT''s drug combination reached the brain and equivocal clinical outcomes were achieved. We have high expectations that this fortuitous combination of these two novel approaches could have an importantly different and positive outcome."

"NexGen is very excited about this collaboration with SCT and ReNeu," said John Kucharczyk, CEO of NexGen Medical Systems. "The novel treatment methods have the potential to introduce entirely new therapies for several neurological diseases and disorders. NexGen''s proprietary EViTAR neurocatheters are designed for delivery of therapeutic agents directly to target tissues in the brain and spinal cord, which is expected to significantly reduce side-effects associated with systemic delivery of drugs," Kucharczyk added.

ReNeu''s initial board will be composed of David Allan, Executive Chairman of Stem Cell Therapeutics, Dr. John Kucharczyk, CEO of NexGen Medical Systems, Dr. Brad Thompson, Chairman & CEO of Oncolytics Biotech and Dr. Joseph Tucker, founding CEO of ReNeu. The Company intends to vigorously pursue regulatory approval to move the combined technologies into clinical trials with a target of clinical initiation in 2014.

SCT will retain all rights to its endogenous stem cell-stimulating technology other than direct-to-brain administration.

About Stem Cell Therapeutics Corp.:

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Stem Cell Therapeutics Announces Joint-Venture Agreement With Reneu Inc. and Nexgen Medical Systems, Inc

Arthritic dogs helped by stem-cell treatment

A Halifax veterinarian is using stem cells to treat dogs suffering from arthritis.

Eamon Draper, a vet at the Fairview Animal Hospital, said they take stem cells from the dog's fat and inject that into its joints.

The procedure takes a few hours and Draper says the improvements can last for years.

"What we're looking for is an animal that's more comfortable and moving around more easily," he said.

The $1,900 process encourages extra blood flow and repairs damage.

David Peyton's 12-year-old black lab Athena was hobbled by arthritis, but the procedure helped her.

"She was sore moving. Getting up and out of her bed and taking her out for her walk, she would come back limping and sore," he said.

A week after the treatment, he said she is moving easier. He's planning a long walk with her at Point Pleasant Park this weekend.

"We wanted to make sure that the last few years of her life were comfortable and pain free and that she can still have a nice quality of life for her senior years," Peyton said.

Draper has treated eight dogs so far. It's a new use of the technology.

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Arthritic dogs helped by stem-cell treatment