America Stem Cell, Inc. Awarded a Phase I SBIR to Explore the Therapeutic Potential of Its Platform Technology (ASC …

SAN ANTONIO--(BUSINESS WIRE)--

America Stem Cell, Inc. (ASC) today announced that it has been awarded an Advanced Technology Small Business Innovation Research (SBIR) grant from the National Heart Lung and Blood Institute at the National Institutes of Health. This grant will be led by Dr. Leonard Miller, VP Preclinical Research at ASC, in collaboration with Dr. Larry Sherman at the Oregon National Primate Research Center, Oregon Health & Science University (OHSU). Dr. Shermans lab has over 15 years of extensive experience in multiple models of demyelinating diseases such as multiple sclerosis (MS), and in the application of these models to identify novel therapeutic approaches. Furthermore, the first-ever transplants of human NSCs into human patients for Batten Disease, a demyelinating disease that affects children, were at Dr. Shermans Institute (OHSU).

The studies outlined within the presently approved grant will examine the effect of ASCs lead technology, ASC-101, in combination with neural stem cells in an experimental mouse model of MS. MS is an autoimmune disease that affects the central nervous system (brain and spinal cord). MS is caused by damage to the myelin sheaths that cover nerve fibers. Degradation of these sheaths causes signals along the nerve fiber to slow down or even stop. Over 400,000 people in the United States have been diagnosed with MS, and the number worldwide is 2.1 million. Presently there is no cure for MS.

America Stem Cell has demonstrated that ASC-101 enhances the ability of stem cells to migrate to their target tissue. While most companies are concerned with the type of cells used for cell therapy (i.e. the hardware), America Stem Cell addresses how to get the cells to go where they are needed most (i.e. the software). With this award, America Stem Cell will expand the potential for therapeutic application of ASC-101 with neural stem cells. According to Dr. Leonard Miller, the Co-Principal Investigator on the grant, The successful combination of ASC-101 with neural stem cells would allow the treatment of not only MS but also potentially a number of other neurological disorders, such as traumatic brain and spinal cord injuries, stroke, and neurodegenerative diseases like amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).

America Stem Cell, Inc. is a clinical stage company that is in clinical trials at the University of Texas M.D. Anderson Cancer Center for improving clinical outcomes for cancer patients undergoing hematopoietic stem cell transplantation. This award enables America Stem Cell to expand the development of ASC-101 to yet another cell type. Lynnet Koh, CEO of America Stem Cell, noted, The combination of ASC-101 with neural stem cells could synergistically enhance the therapeutic and regenerative capacity of these cells and most importantly provide an off-the-shelf, effective solution for nerve damage due to multiple types of injuries or diseases. ASC-101 is a transformative technology with the potential to improve clinical outcomes for patients undergoing a wide variety of cell therapies for the treatment of diseases such as graft versus host disease, diabetic complications, neurological disorders, and ischemic diseases such as myocardial infarctions, retinopathy and critical limb ischemia. America Stem Cell has established a number of collaborations examining the potential of ASC-101 to improve cell therapies for multiple clinical conditions using a wide variety of cell types.

About America Stem Cell, Inc.

America Stem Cell is a privately held biotechnology company based in San Antonio, TX, with offices in San Diego, CA, and is dedicated to the development and commercialization of enabling technologies to enhance and expand the therapeutic potential of cell therapies. The key technology platforms (ASC-101 and ASC-102) are designed to improve the homing and engraftment of cells to target organs. ASC-101 is currently in clinical trials to improve the therapeutic potential of hematopoietic stem cells for patients in need of hematopoietic stem cell transplantation. Additionally, these technologies have the potential to enhance the efficacy of cell therapies for the treatment of inflammation from chemotherapy/radiation, autoimmune diseases, neurological diseases, and ischemic diseases including myocardial infarction and stroke. America Stem Cell has partnerships and collaborations with Kyowa Hakko Kirin, Spectrum Medical Innvoations, Florida Biologix, and various medical research institutions including the University of Texas M.D. Anderson Cancer Center, Oklahoma Medical Research Foundation, Fred Hutchinson Cancer Center, University of California San Diego, Sanford-Burnham Institute, Indiana University, Juvenile Diabetes Research Foundation, as well as corporate partnerships. For additional information, please contact Lynnet Koh at 760-612-6277, or view http://www.americastemcell.com.

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America Stem Cell, Inc. Awarded a Phase I SBIR to Explore the Therapeutic Potential of Its Platform Technology (ASC ...

Study Shows Promising Results Using Cord Blood Stem Cells to Treat Cerebral Palsy

OLDSMAR, Fla., Jan. 8, 2013 (GLOBE NEWSWIRE) -- (CCEL) Cryo-Cell International Chief Scientific Officer Linda L. Kelley, PhD, expressed optimism that an effective treatment for cerebral palsy (CP) using cord blood stem cells may be on the horizon now that the first results of a Phase 2 study have been published. The paper by Dr. Min Young Kim and colleagues is the first to demonstrate efficacy using umbilical cord blood as therapy in a large, placebo-controlled, double-blind study in South Korea.

Cerebral palsy (CP) is a devastating disability acquired in early childhood which affects approximately 10,000 babies per year and results in lifelong motor and cognitive functional deficits. Dr. Kim's team treated 96 children between the ages of 10 months and 10 years. Patients were divided into three groups:

EPO was included in the study because of its previously demonstrated neural repair properties. In addition, all patients experienced an intensive one month in-patient rehabilitation program.

Dr. Kelley noted, "The study results are of profound importance and provide optimism for parents of thousands of children suffering with CP and for unborn children at risk of acquiring CP. Since there are few, if any, early warning signs predicting who will be affected by CP, these results should encourage all families to consider storing umbilical cord blood when the option is available to them."

The study results seem to indicate that patients receiving autologous cord blood may have even better outcomes. Several clinical trials using autologous cord blood to treat cerebral palsy are on-going in the United States. Dr. Kelley commented, "Results from those studies should greatly extend our knowledge of the usefulness of cord blood for the treatment of a devastating condition for which there is currently no known treatment."

Motor function and cognitive development changes were measured using an extensive group of well-established tests. The tests were performed at the initiation of the study and again at 1, 3 and 6 months. The data consistently revealed superior outcomes in the group that received cord blood compared to the other two groups. The differences were significant starting from 1 month or 3 months post-treatment and continued to 6 months post-treatment.

Some adverse events requiring hospitalization were noted; however, the incidence was the same regardless of the treatment group. Pneumonia and irritability were more frequent in the group that received cord blood than in the other two groups. Considering the overall frequency and severity of the adverse events, the authors concluded that the risks were not prohibitive to continued investigation of this new therapy for cerebral palsy.

HLA-matched allogeneic cord blood units were used in this study due to the unavailability of previously banked autologous cord blood. Complete information on the study is available here.

About Cryo-Cell International

Cryo-Cell International, Inc. was founded in 1989. In 1992, it became the first private cord blood bank in the world to separate and store stem cells. Today, nearly 500,000 parents from 87 countries trust Cryo-Cell to preserve their family members' stem cells. Cryo-Cell's mission is to provide clients with state-of-the-art stem cell cryopreservation services and support the advancement of regenerative medicine. Cryo-Cell operates in a facility that is compliant with Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP), and is ISO 9001:2008 certified and accredited by the American Association of Blood Banks. Cryo-Cell is a publicly traded company, OTC:QB Markets Group Symbol: CCEL. For more information, visit http://www.cryo-cell.com.

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Study Shows Promising Results Using Cord Blood Stem Cells to Treat Cerebral Palsy

Supreme Court lets embryonic stem cell research proceed

By M. Alex Johnson, NBC News

The Supreme Court refused to step into the emotionally charged debate over embryonic stem cell research Monday, declining to hear a case that sought to stop government funding on ethical grounds.

The decision leaves in place President Obama's 2009 executive order expanding research on stem cells taken from human embryos, which many scientists say has the potential to produce breakthroughs in treatment of numerous conditions, particularly spinal cord injuries, diabetes and Parkinson's disease.

Obama reasoned that research on stem cell lines from embryos created through in vitro fertilization was not ethically problematic.Congress banned the creation or destruction of embryos for research purposes in 1996.

A federal court in Washington, D.C., issued an injunction temporarily blocking the order in August 2010 after two scientists opposed to all embryonic stem cell research, James Sherley of the Boston Biomedical Research Institute and Theresa Deisher of Sound Choice Pharmaceutical Institute, sued on behalf of "plaintiff embryos," contending that Congress had forbidden any research whatsoever on embryonic stem cells.

Since then, federal courts have rejected their contention that the failure of the National Institutes of Health and the Department of Health and Human Services to respond to their arguments rendered Obama's policy illegal.

Watch US News videos on NBCNews.com

The Supreme Court made no comment Monday in its one-sentence order rejecting the scientists' appeal.

Embryonic stem cells have been the focus of fierce debate since the mid-1990s. Many scientists see them as a watershed in the treatment of serious ailments because they have the potential to grow into any of the body's cell types, promising the eventual generation of replacement nerve lines and vital organs, including the brain and the heart.

But anti-abortion activists vigorously oppose the research because the cells come from human embryos and days-old human fetuses, which they contend are fully human.Many of them, including Sherley, want to limit research to stem cells derived from adult tissue, which most researchers contend have less potential to transform into other types of cells.

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Supreme Court lets embryonic stem cell research proceed

Treatment restores sight in mice

Treatment restores sight in mice

7:00pm Tuesday 8th January 2013 in News

REVOLUTIONARY stem cell treatment has given sight back to mice that were formerly completely blind.

Oxford University researchers transplanted cells into the eyes of mice that had lost their sight due to losing the light-sensing photoreceptor cells in their retinas.

They found they could reform the entire light-sensitive layer of the retina.

After the treatment, nocturnal mice that previously did not notice any difference between light and dark ran away from light and preferred to be in the dark, in the same way as mice with normal vision.

Prof Robert MacLaren, of the Nuffield Department of Clinical Neurosciences at Oxford University, led the research along with eye surgeon Dr Mandeep Singh, who is from the National University Hospital of Singapore and undertaking PhD studies in Oxford.

Prof MacLaren said: Stem cells have been trialled in patients to replace the pigmented lining of the retina, but this new research shows that the light-sensing layer might also be replaced in a similar way.

He said this could lead towards potential cell treatments for blindness in humans using stem cells generated from patients own cells.

He said: All the steps are there for doing this in patients in the future. Our study shows what we could achieve with a cell-based approach.

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Treatment restores sight in mice

Stem Cell Transplant Studies Raise Hopes Of Treatment For ALS

Featured Article Academic Journal Main Category: Muscular Dystrophy / ALS Also Included In: Stem Cell Research;Neurology / Neuroscience Article Date: 08 Jan 2013 - 3:00 PST

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A summary of all 11 studies, plus the results of the meta-analysis of their pooled data, can be found in a paper published in the 19 December online issue of the journal Science Translational Medicine.

Co-lead author of the paper Yang (Ted) Teng is a Harvard Medical School (HMS) associate professor of surgery at Brigham and Women's Hospital in Boston, Massachusetts, in the US. He and his colleagues believe the key to treating ALS lies in targeting new mechanisms uncovered by studies into neural stem cells.

Their review takes in a decade of research from several institutions. As well as Brigham and Women's, it covers results from studies conducted at Johns Hopkins University, the VA Boston Healthcare System, Boston Children's Hospital, Sanford-Burnham Medical Research Institute, UMass Medical School, SUNY-Syracuse, and Columbia University.

Teng says in an HMS statement released last week:

"This significant research will help us better understand the mechanisms underlying motor neuron diseases."

Neural stem cells are the precursors of all brain cells. They can self-renew, make more neural stem cells and differentiate into nerve cells or other brain cells. They can also rescue nerve cells that don't work properly and help preserve and regenerate brain tissue.

Teng says:

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Stem Cell Transplant Studies Raise Hopes Of Treatment For ALS

Full Force’s Bowlegged Lou Tells of His Brother Paul Anthony’s Stem Cell Transplant in Emotional Post

Paul Anthony George

*As weve reported over the past year, Full Forces Paul Anthony has been bravely dealing with a cancer condition called mantle cell lymphoma.

A few days ago, as part of the treatment, Paul went through bone marrow stem cell transplant. The donor was his brother, Bowlegged Lou, who chronicled the event as only he could with a lot of love, humor and raw emotion.

From Lou (The Bowlegged One): My lil Testimony.

First, Happy New Year to everyone and their family and friends. I want to thank all my family and friends for your prayers and positive thoughts regarding my beloved brother Paul Anthony. (Also earlier thanks for the prayers of support for our mother when she spent 8 days in the hospital during the Thanksgiving week. )

The bone marrow stem cell transplant between Paul & myself went well. Thats the 1st phase as we aint through yet. We must keep sending prayers for Pauls brand-Lou immune system, oops did I say brand-Lou? I meant brand new. ) His brand new immune system must now take 9 to 12 days to set in for his blood counts to go up, then months of safe guard period to officially take shape and become whole. Prayers must continue and continue, as Paul has been such a positive & brave lion through this whole journey of his.

Paul Anthony & Bowlegged Lou

Regarding this stem cell bone marrow transplant, the doctors were looking at me to do 2 days in the Donors hospital & to hopefully give Paul 6 million stem cells total. I ended up doing it in 1 day with 2 catheters in both arms & for 4 hours I spit out 9 million stem cells to everyones surprise including the docs. Not 6 mil in 2 days but 9 mil in 1 day. Paul got all 9 mil from me. (If u see Paul start putting stickers on peoples backs or pulling pranks, youll know why.)The docs said that for my age I had a healthy bone marrow of a teenager but the host vs graft must still succeed in on-going time in order to be complete, and with Gods eyes it will. Prayers must continue.

But again, so far so good. Paul looks good, sounds better. Again hes been so strong through it all though this latest chemo trial in the hospital rocked him the most cause it was so intense. Im just happy that I was an exact blood match to my brother because only 25 % of all siblings turn out to be matches.

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Full Force’s Bowlegged Lou Tells of His Brother Paul Anthony’s Stem Cell Transplant in Emotional Post

BrainStorm's Clinical Trial is Fast-Tracked to Phase IIa, Representing a Major Milestone for the Company

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 the Israeli Ministry of Health has fast-tracked its current Phase I/II ALS safety trial to a Phase IIa dose-escalating trial, significantly expediting the companys clinical development program and saving valuable time. The trial, which will evaluate the safety and preliminary efficacy of BrainStorms NurOwn stem cell therapy candidate, will be launched immediately at the Hadassah Medical Center in Jerusalem.

The Ministry of Health approved acceleration to a Phase IIa trial based on evaluation of only 12 of the initial cohort of 24 patients in the companys Phase I/II trial at Hadassah. In the Phase IIa trial, the second group of 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. The study participants, who have already been recruited, will be followed for three to six months after transplantation.

Acceleration to Phase IIa will save us critical time, enabling us to proceed much more quickly with achieving our goal of developing an effective treatment for ALS, commented Dr. Adrian Harel, BrainStorms CEO.

Professor Dimitrios Karussis, Principal Investigator of BrainStorms Phase I/II trial at Hadassah, commented: Based on the positive results we have seen for the first 12 patients, we are eager to begin the next stage of clinical testing, and are delighted that the Ministry of Health has given us the green light to proceed to Phase IIa.

BrainStorm has been conducting a Phase I/II clinical trial in ALS patients at the Hadassah Medical Center in Jerusalem since June 2011, and plans to launch the Phase IIa study immediately. The company is also planning to expand its clinical development to the United States in 2013, 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, Inc.

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.

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's Clinical Trial is Fast-Tracked to Phase IIa, Representing a Major Milestone for the Company

BioTime Signs Definitive Agreement With Geron Regarding Stem Cell Assets

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

BioTime, Inc. (NYSE MKT: BTX) and its recently formed subsidiary BioTime Acquisition Corporation (BAC) jointly announced today that they have entered into a definitive Asset Contribution Agreement with Geron Corporation (GERN) to acquire the intellectual property, including patents and patent applications, and other assets related to Gerons human embryonic stem (hES) cell programs consistent with the financial terms outlined in the letter of intent announced on November 15, 2012.

Under the definitive agreement, Geron will contribute to BAC intellectual property, certain cell lines and other assets, including the Phase 1 clinical trial of hES cell-derived oligodendrocytes in patients with acute spinal cord injury, and Gerons autologous cellular immunotherapy program. BioTime will contribute to BAC $5 million in cash, 8,902,077 BioTime common shares to be held by BAC, five-year warrants to purchase 8,000,000 common shares of BioTime at a price of $5.00 per share (BioTime Warrants), rights to use certain clinical grade hES cell lines, a sublicense to use certain patents for stem cell differentiation technology, and minority stakes in two of BioTimes subsidiaries, OrthoCyte Corporation and Cell Cure Neurosciences Ltd. BAC will also pay to Geron royalties on the sale of products that are commercialized, if any, in reliance upon Geron patents contributed or licensed to BAC. A private investor has also agreed to provide an equity investment of $5 million in BAC and a $5 million equity investment in BioTime in conjunction with the transaction.

Geron pioneered the field of regenerative medicine in the mid-1990s by organizing the first effort to isolate human embryonic stem (hES) cells. hES cells are early-stage stem cells that are capable of becoming all of the cell types in the human body, and therefore are widely recognized as a means of manufacturing cells that are potentially useful in regenerating tissue function for a wide array of degenerative diseases. Currently, Gerons hESC patent portfolio includes over 400 patents and patent applications that will be transferred or sublicensed to BAC. Geron obtained the first approval from the Food and Drug Administration for human clinical trials of a product manufactured from hES cells.

Gerons former hES cell programs included oligodendrocyte progenitor cells for central nervous system disorders, cardiomyocytes for heart disease, pancreatic islet cells for diabetes, dendritic cells as an immunotherapy vehicle, and chondrocytes for cartilage repair. BAC may pursue the development of therapeutic products from some or all of these cell types, depending upon a number of factors, including the expected cost of development, sufficiency of financing, the state of development of the technology acquired, regulatory considerations, anticipated market size, and competition from other companies in the applicable fields. BAC may also seek to develop other therapeutic products, taking into account the same or other applicable considerations.

Our consistent goal at BioTime has been to consolidate the pluripotent stem cell technology platform, stated Michael West, Ph.D., Chief Executive Officer of BioTime, Inc. With this contribution of assets, the combined intellectual property estate in the BioTime family of companies will be among the strongest in the field of Regenerative Medicine; establishing our leadership in the industry and advancing product development.

We are excited aboutour approach toward consolidating themost importanttechnologies in Regenerative Medicine, said Thomas Okarma, M.D., Ph.D., president and CEO of BAC. Regenerative Medicineholds great promise for patientsand now, with our significant collection of world class stem cell technologies, IP, and experienced management, we arepositioned tohelp realize that promise.

Closing of the transactions under the definitive agreement is subject to certain negotiated closing conditions, including the registration of the BAC Series A common stock, the BioTime common shares contributed to BAC, and the BioTime Warrants under the Securities Act of 1933, as amended, and certain approvals by BioTime shareholders. The transaction is expected to close no later than September 30, 2013.

Upon closing of the transaction, Geron will receive BAC Series A common stock, and BioTime and the private investor will receive BAC Series B common stock in the transaction. The Series A and Series B common stock will be identical, except that BAC will be entitled to make certain distributions or pay dividends on its Series A common stock without making a distribution or paying a dividend on its Series B common stock.

Following the closing of the transaction, Geron will distribute on a pro rata basis to its stockholders the shares of BAC Series A common stock received in the transaction. Following that distribution by Geron, BAC will distribute on a pro rata basis to the holders of those shares the BioTime Warrants. The Series B common stock will be convertible into Series A common stock following the distribution of the BioTime Warrants.

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BioTime Signs Definitive Agreement With Geron Regarding Stem Cell Assets