Stem Cell Clinic

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

Ovarian cancer stem cell study puts targeted therapies within reach

Public release date: 7-Jan-2013 [ | E-mail | Share ]

Contact: Karen N. Peart karen.peart@hotmail.com 203-432-1326 Yale University

Researchers at Yale School of Medicine have identified a key link between stem cell factors that fuel ovarian cancer's growth and patient prognosis. The study, which paves the way for developing novel targeted ovarian cancer therapies, is published online in the current issue of Cell Cycle.

Lead author Yingqun Huang, M.D., associate professor in the Department of Obstetrics, Gynecology & Reproductive Sciences, and her colleagues have demonstrated a connection between two concepts that are revolutionizing the way cancer is treated.

First, the "cancer stem cell" idea suggests that at the heart of every tumor there is a small subset of difficult-to-identify tumor cells that fuel the growth of the bulk of the tumor. This concept predicts that ordinary therapies typically kill the bulk of tumor cells while leaving a rich environment for continued growth of the stem cell tumor population.

The second concept, dubbed "seed and soil," defines a critical role for the tumor cells' "microenvironment," which is the special environment required for cancer cell growth and spread.

"Both concepts have particular relevance for the treatment of adult solid tumors such as ovarian cancer, which has been notoriously difficult to diagnose and treat," said co-author Nita J. Maihle, M.D., professor in the Department of Obstetrics, Gynecology & Reproductive Sciences and a member of Yale Cancer Center. "Ovarian cancer patients are plagued by recurrences of tumor cells that are resistant to chemotherapy, ultimately leading to uncontrolled cancer growth and death."

In this study, Huang and her colleagues were able to define a molecular basis for the interplay between these two concepts in ovarian cancer. They did this by using sophisticated gene sequencing methods to demonstrate a regulatory link between the stem cell factor Lin28 and the signaling molecule bone morphogenic protein 4 (BMP4).

"These results are supported by the latest molecular ovarian cancer prognosis data, which also suggest an active role for the tumor microenvironment in ovarian carcinogenesis," said Huang and Maihle. "Together these studies reveal new targets for the development of cancer therapies."

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Ovarian cancer stem cell study puts targeted therapies within reach

International Stem Cell Corporation Announces Positive Animal Efficacy Results in Liver Disease Program

CARLSBAD, CA--(Marketwire - Jan 7, 2013) - International Stem Cell Corporation ( OTCQB : ISCO ) (www.internationalstemcell.com) ("ISCO" or "the Company") a California-based biotechnology company, today announced positive top line efficacy results from its pre-clinical in vivo liver study.The primary goal of the efficacy study was to demonstrate the therapeutic equivalence of human parthenogenetic stem cell (hpSC)-derived hepatocytes to adult liver cells as a prerequisite for using such cells in the treatment of metabolic liver diseases including Crigler-Najjar Syndrome.

Crigler-Najjar Syndrome (CNS) is a rare inherited disorder in which bilirubin, a substance made by the liver, cannot be broken down by the liver.The build-up of this toxic compound can lead to damage to the brain, muscles, and nerves and eventually cause death.Current treatment paradigms for CNS include phototherapy and blood transfusions, but these do not treat the underlying cause of the disease.Hepatocyte transplantation has emerged as a therapeutic strategy, and has been successfully applied to treat patients with CNS, however the extremely limited availability of human livers and therefore of donated primary hepatocytes makes a stem cell based approach attractive.

These ISCO study results demonstrate that the hpSC-derived hepatocytes engraft in the liver of Gunn rats and behave in a similar manner to primary human hepatocytes.The Gunn rat is a well-established model of CNS and has been used extensively to study bilirubin toxicity and hepatocytes transplantation.Additionally, the study indicates that a single intrasplenic injection of hpSC-derived hepatocytes results in a change in the plasma indirect bilirubin level equivalent to that achieved by injecting primary hepatocytes.Establishing the equivalence of hpSC-derived and donor-derived hepatocytes in their ability to metabolize bilirubin supports the thesis that hpSC-derived hepatocytes can be used therapeutically as a substitute for donated primary liver cells.

"Achieving this milestone is very encouraging," said Dr. Andrey Semechkin, CEO and Co-chairman of ISCO. "These results suggest that hpSC-derived hepatocytes could be a well suited alternative to donated primary hepatocytes as a source of cells in clinical applications including the treatment of Crigler-Najjar Syndrome."

About International Stem Cell CorporationInternational 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.

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Safe harbor statement Statements pertaining to anticipated developments, the potential use of technologies to develop therapeutic products and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects" or "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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International Stem Cell Corporation Announces Positive Animal Efficacy Results in Liver Disease Program

Patients seek stem-cell 'miracle,' but scientists warn of dangers

Boca Raton parents Gary and Judy Susser say they know the hope and promise of stem-cell therapy. Nine years ago they traveled to Mexico for stem cell injections for their son Adam, who has cerebral palsy.

"Maybe it will do some good," Gary Susser said he and his wife thought at the time. They spent $25,000.

But the Sussers stopped stem cell injections in 2005, after spending about $25,000 and seeing no improvement. Now armed with more information, the Sussers are grateful the treatments didn't harm Adam, now 12. While they are advocates of "responsible" stem cell research, they warn other parents against making trips to Costa Rica, Mexico, Russia or other offshore clinics for experimental treatments.

With promising breakthroughs making the news, as well as Internet hype, desperate parents and seriously ill patients may look to stem-cell therapy as the modern miracle that could cure them. And one day, stem cells may be routinely used to repair damaged cells, improve the treatment of diseases and even cure paralysis.

But there are hidden dangers to today's stem cell treatments, both in the U.S. and offshore, scientists said at the recent World Stem Cell Summit in West Palm Beach. They pointed to reports of deaths, tumors, lumbar punctures and other potential harm, as well as vulnerable people being conned out of thousands of dollars.

Patients are "buying hope," said University of Miami scientist James Guest, working on The Miami Project to Cure Paralysis. But he and other scientists say that responsible research takes years to complete. The Miami Project, in the making for 25 years, is just now reaching the human clinical trial stage, he says.

Scientists urge consumers look for regulated clinical trials at universities and research institutions, saying that even those are not without risks.

"Clinics are operating out of loopholes, a gray area disguised as the practice of medicine," said George Q. Daley, director of the stem cell transplantation program at HHMI/Children's Hospital in Boston.

Industry researcher Douglas Sipp has kept records of more than 400 companies advertising stem cell products or procedures on websites since 2007. When he rechecked this summer, Sipp said 80 of the sites were no longer online, though they could have simply changed web addresses.

Some of the offshore clinics have been closed by individual countries after patients died, according to Sipp, who leads the research unit for Science Policy and Ethics Studies at the RIKEN Center in Japan.

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Patients seek stem-cell 'miracle,' but scientists warn of dangers

Perry brings Texas stem-cell cause to Houston

Gov. Rick Perry pushed Friday for Texas to become the center of adult stem-cell therapy, disregarding the federal government's increasing crackdown on clinics marketing the experimental medicine.

Perry told a crowd of stem-cell researchers, industry leaders and patients gathered in Houston that the young science "holds the promise of miracles" desperately needed by people across the world and suggested Texas' "wildcat spirit" and "conducive climate" can make it happen here.

"I'm not shy about asking people to relocate or start up their companies in Texas," said Perry, likening stem-cell treatment to previous innovations in space and heart care. "All of you outside the state of Texas - come on in. The water's fine. We've got an amazing environment here."

Perry, who famously got the unlicensed treatment for an ailing back in 2011, said the state has made sure that innovators won't be "hindered by exorbitant taxes, wrapped up by bureaucratic red tape or at the mercy of predatory attorneys, seeking to make steady money off extensive, drawn-out court cases."

Perry's remarks, made at the first of a planned annual Houston conference, came as the state appears headed toward a collision with the Food and Drug Administration, which has begun stepping up action against businesses that treat patients with their own stem cells. Last month, it issued a warning letter to Celltex Therapeutics Corp., the largest facilitator of the therapy in the Houston area, saying the process it puts the cells through alters them and makes them a biologic drug. The letter said the therapy was thus under FDA jurisdiction.

Perry's position

The letter was delivered just a few months after the Texas Medical Board began implementing a policy allowing doctors to use stem cells banked at facilities such as Celltex as long as it's part of research overseen by a panel that reviews clinical trials for patient safety. The TMB said it was allowing stem-cell use because it couldn't wait on the FDA.

As a result of the FDA letter, Celltex is in the process of closing down its 2012 trials.

Perry told the media after his keynote address that he disagrees with the FDA's decision on Celltex. He said that therapy involving one's own stem cells should no more be regulated by the FDA than bone marrow transplants or in-vitro fertilization.

Stem cells are cells in the body that multiply to replenish dying cells. The basis of what's known as regenerative medicine because of their ability to grow new tissue and repair diseased or injured body parts, they are touted by some as the future of medicine.

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Perry brings Texas stem-cell cause to Houston

Gene variation may shape bladder cancer treatment, study suggests

Jan. 3, 2013 Patients who have inherited a specific common genetic variant develop bladder cancer tumors that strongly express a protein known as prostate stem cell antigen (PSCA), which is also expressed in many pancreatic and prostate tumors, according to research at the National Institutes of Health.

A therapy targeting the PSCA protein on the tumor cell surface is under evaluation in clinical trials for prostate and pancreatic cancer. The researchers hope that this therapy will be tested in bladder cancer patients with the genetic variant, which could help to reduce potentially harmful side-effects, lower costs, and improve treatment efficacy.

Every gene contains a very long string of DNA components termed nucleotides (referenced commonly as T, C, G or A). A single letter variation in the string of letters can lead to changes in cell development, resulting in cancer.

In a previous study, the researchers identified a variant located in the PSCA gene on chromosome 8 as associated with bladder cancer susceptibility. The gene determines whether the corresponding protein is expressed in bladder tumor tissue. In the latest report, they found that the 'T' nucleotide that comprises a gene variant called rs2294008 is a strong predictor of PSCA protein expression. The variant results in increased delivery of the protein to the cell surface, where it is involved in signaling and promotes tumor growth. The study by scientists from the National Cancer Institute (NCI), part of the National Institutes of Health, appeared online in the Journal of the National Cancer Institute on Dec. 23, 2012.

"We've been pursuing this mechanism for some time now. It started with our early results from the initial genome-wide association study that revealed a marker in the PSCA gene related to bladder cancer risk. This latest work reveals how a specific letter change in DNA influences protein expression at the cell surface. The big payoff is that a simple genetic test can determine which patients could benefit from anti-PSCA therapy," said Ludmila Prokunina-Olsson, Ph.D., NCI Division of Cancer Epidemiology and Genetics, and senior author of this publication.

In 2012 in the United States alone, there were an estimated 73,510 new cases of bladder cancer and 14,880 deaths. The recurrence rate of bladder cancer is between 50 and 70 percent, and patients require life-long surveillance and treatment, making it an expensive cancer to live with and a major economic burden on the health care system and patients. Up to 75 percent of bladder cancer patients carry this genetic variant.

"This is one of the first studies to show direct clinical implications of a genetic variant identified through genome-wide association studies for common cancers," said Stephen J. Chanock, M.D., acting co-director for the NCI Center for Cancer Genomics.

The scientists note that additional work is needed to develop alternative drugs targeting PSCA, and to evaluate drug delivery methods, such as systemic delivery for advanced muscle-invasive tumors and local, inter-bladder delivery in the case of non-muscle invasive tumors. Anti-PSCA therapy is likely to be effective only against tumors that express PSCA. A genetic test for the "T" nucleotide of this genetic variant can identify bladder cancer patients who could benefit from this treatment.

This research was supported by intramural funding at the NCI under contract number ZIA CP010201-04.

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Gene variation may shape bladder cancer treatment, study suggests