BrainStorm Launches US Activities for Its Multi-Center ALS Clinical Trial

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has launched its activities in the US in preparation for its Phase IIa multi-center clinical trial, with the initiation of the NurOwn technology transfer process at the Dana Farber Cancer Institute (DFCI). DFCIs Connell and O'Reilly Cell Manipulation Core Facility will produce NurOwn in its cGMP-compliant clean room facilities for the MGH and UMass Hospital clinical sites. The third clinical site in the trial, Mayo Clinic, will produce NurOwn at its own cleanroom facility.

We are very pleased with the progress we are making at DFCI, this being the final step for submission of the Company's IND application to the US FDA, commented Mr. Chaim Lebovits, BrainStorms President.

The Cell Manipulation Core Facility (CMCF) at Dana-Farber Cancer Institute (DFCI) is a manufacturing facility that produces safe and effective novel cellular component therapy that meets all regulatory guidelines for clinical use and also facilitates research to be translated from the bench to the bedside. All procedures are performed in environmentally controlled conditions according to current Good Manufacturing Practices (cGMP) for cell and tissue processing.

In 2012 BrainStorm successfully completed its first-in-man Phase I/II clinical study at Hadassah Medical Center in Jerusalem with 12 ALS patients, demonstrating initial indications of clinical benefit in six patients. BrainStorms Phase IIa dose-escalating trial at Hadassah is currently underway and the company will release the preliminary efficacy data at the conclusion of the trial.

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 Launches US Activities for Its Multi-Center ALS Clinical Trial

Tendon treatment firm seeks new markets

Regenerative medicine company Orthocell has been recognised in a prestigious peer-reviewed journal for its tendon injury treatment, which uses stem cell technology.

The treatment, known as Autologous Tenocyte Implantation (ATI), involves taking a biopsy of the patient's healthy tendon, isolating and cultivating tendon stem cells from the tissue, then injecting them into the injured tendon.

The Perth-based company says the process takes about 20 minutes and is less invasive than surgery.

Professor Ming Hao Zheng of the University of Western Australia's Centre for Translational Orthopaedic Research, who led the development team, said treatment options for people suffering from tendon injury and related disorders were limited.

"There are no targeted drug therapies and surgery often delivers unsatisfactory results," Prof Zheng said.

But ATI has been hailed in the American Journal of Sports Medicine as a safe and effective procedure that repairs tendons and reduces the pain of conditions such as tennis elbow.

"This novel treatment is encouraging for the treatment of tendinopathy and warrants further evaluation," the journal concluded.

Orthocell managing director Paul Anderson said the company was now focused on offering the treatment more widely to patients throughout Australia and New Zealand, and was also investigating potential overseas markets.

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Tendon treatment firm seeks new markets

World-first Trial for Tendon Repair Using Tendon Stem Cells Published in the Prestigious American Journal of Sports …

PERTH, Australia, Oct. 2, 2013 /PRNewswire/ -- Regenerative medicine company, Orthocell Limited (Orthocell), today announced the results of its unprecedented and successful clinical trial for the treatment of tendon injuries using its patented stem cell technology. Tendon injuries are one of the most common causes of occupational and sporting disability and current clinical treatments are only moderately effective.

Orthocell's new technique is known as Autologous Tenocyte Implantation (Ortho-ATIT) and involves biopsy of the patient's own healthy tendon, isolation and cultivation of tendon stem cells from the biopsy in a special laboratory and then injection of these cells back to the injured tendon. The process takes about 20-minutes and is less invasive than surgery.

The company has received international profiling and recognition in the prestigious American Journal of Sports Medicine (AJSM), with a peer reviewed publication of the world first study on Ortho-ATIT stem cell technology for regeneration of damaged human tendon.

The AJSM, which is ranked as the world's number one journal for orthopaedics and sports medicine, published outcomes of the clinical trial last week. The data demonstrates that Orthocell's novel technology for repairing tendons was a safe and effective procedure that enables a reduction in pain and repairs tendon in severe chronic resistant tendon injury, like tennis elbow. The patients treated in the study, had failed at least one previous therapy including physiotherapy and corticosteroid injection. Patients achieved significant improvement in function and structural integrity of the tendon after the Ortho-ATIT tendon stem cell injection.

Orthocell Managing Director Paul Anderson said the clinical study indicates great potential for the Ortho-ATIT stem cell tendon repair.

"The AJSM paper is a benchmark study that validates the repair of tendon using tendon derived stem cells. We are now focussing our efforts on offering this world class treatment more widely to patients throughout Australasia, and we are also investigating new potential markets overseas," said Mr Anderson.

The technique was the result of more than 10 years development by Professor Ming Hao Zheng's group at the Centre for Translational Orthopaedic Research at the University of Western Australia, one of the top one hundred universities in the World.

"This is a very exciting body of work, which is indicated for a large patient population. There are currently limited treatment options for people suffering from tendon injury and related disorders, as there are no targeted drug therapies and surgery often delivers unsatisfactory results. This published study of Ortho-ATIT strongly suggested that substitution of tendon stem cells enables regeneration of tendon," said Professor Zheng.

Amanda Redwood, a 45-year-old mother of two who participated in the trial, said Orthocell's treatment relieved her of severe elbow pain within 6 months.

"I experienced debilitating symptoms of tennis elbow for more than 16-months before I had the procedure. Within 6 weeks of the injection the pain started to subside, and within 6 months it was gone," said Ms Redwood.

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World-first Trial for Tendon Repair Using Tendon Stem Cells Published in the Prestigious American Journal of Sports ...

BioRestorative Engages Consulting Firm to Advance brtxDISC™ Program Delivery Device through FDA Clearance Process

JUPITER, Fla.--(BUSINESS WIRE)--

BioRestorative Therapies, Inc. ("BRT" or the "Company") (BRTX), a life sciences company focused on developing stem cell-based therapies for personal medical applications, announced the engagement of the regulatory consultancy firm Phil Triolo and Associates, LC (PTA) to help advance the Companys brtxDISC therapeutic procedure through the U.S. Food and Drug Administration (FDA) regulatory process. The brtxDISC program is the Companys non-surgical investigative treatment for bulging and herniated lumbar discs.

Under the engagement, PTA will assist the Company in its efforts to obtain U.S. regulatory approval and to satisfy FDA regulations applicable to the Companys medical device used in the brtxDISC procedure, including the implementation of quality systems procedures. In addition, PTA will assist BRT in its efforts to satisfy FDA regulations relevant to the combination products (biologic plus device) it ultimately plans to commercialize in the U.S. PTA is also available to assist in any international regulatory approval processes the Company may pursue.

This is an important step in advancing the development of our brtxDISC procedure, said Mark Weinreb, chief executive officer of BioRestorative Therapies. We have developed a minimally invasive, technologically innovative medical device to precisely deliver a patients own stem cells directly into the damaged region of the herniated and bulging disc, which is a key component of the success of the procedure.

There are approximately one million aggressive surgical back and spine procedures in the U.S. each year, including discectomies, disc replacements and spinal fusions. Our goal is to offer an alternative to these procedures by providing a cellular procedure to assist the patients body in repairing the disc. Pending regulatory approval, we look forward to commencing clinical trials in mid-2014, Mr. Weinreb added.

Phil Triolo and Associates, LC provides services to assure compliance with U.S. regulatory requirements during all stages of the product lifecycle, from feasibility, design and development, to manufacturing, post-production vigilance and audits.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops products and medical procedures using cell and tissue protocols, primarily involving adult stem cells, including:

The Company also offers plant stem cell-based facial creams and beauty products under theStem Pearlsbrand atwww.stempearls.com.

This press release contains "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, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

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BioRestorative Engages Consulting Firm to Advance brtxDISC™ Program Delivery Device through FDA Clearance Process

West Coast Stem Cell Clinic, TeleHealth, Now Offering Treatment with Stem Cells for Shoulder Arthritis and Tendonitis

Orange County, CA (PRWEB) October 02, 2013

The leading regenerative medicine clinic on the West Coast, TeleHealth, is now offering treatment with stem cells for shoulder arthritis and tendonitis. The treatments are performed as an outpatient and include autologous stem cell treatments that are derived from either bone marrow or fat along with PRP therapy. The treatments are often covered by insurance, and the doctors are Board Certified with years of experience in stem cell therapy. Call (888) 828-4575 for more information and scheduling.

Shoulder injuries are not frustrating just for high level athletes. Even individuals who perform overhead work, are involved in a car accident or simply dealing with degenerative arthritis may suffer from chronic shoulder pain. Traditional treatments may provide pain relief, however, prior to undergoing surgery regenerative medicine treatments should be considered with stem cell therapy.

TeleHealth offers Board Certified stem cell doctors treating shoulder pain with several options for stem cell therapy. This may include rotator cuff tendonitis, labral tears, shoulder joint arthritis, biceps tendonitis, rotator cuff tears or impingement syndrome. These may take many months to heal without stem cell treatment and there is a distinct possibility the injury may not heal due to the bodys inability to develop the repair response necessary.

The stem cell treatments offered at TeleHealth include platelet rich plasma therapy (PRP therapy) and autologous stem cell therapy from either bone marrow or fat. These treatment options may be combined to deliver the maximum effectiveness for healing response. The results to date have been impressive for speeding up healing response along with initiating healing in injuries that were unresponsive to traditional nonoperative options.

The treatments are often covered by insurance at TeleHealth, are low risk, and all performed by Board Certified doctors as an outpatient. For more information and scheduling, call (888) 828-4575.

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West Coast Stem Cell Clinic, TeleHealth, Now Offering Treatment with Stem Cells for Shoulder Arthritis and Tendonitis

Regenestem Announces Plans to Create a Stem Cell Treatment Center in Collaboration with CMC Hospital Group in Cozumel …

Miami, FL (PRWEB) October 02, 2013

Regenestem, a division of the Global Stem Cells Group, Inc., this week announced plans to create a stem cell treatment center in Cancun, Mexico that will offer the most advanced protocols and techniques in cellular medicine to patients from around the world.

The new Regenestem team in Cancun will be led by Rafael Moguel, M.D., a specialist in cardiology and interventional cardiology from Clinic of The Heart facility in Los Cabos, Mexico. An advocate and pioneer in the use of stem cell therapies to treat a wide variety of conditions, Moguel is joined by a team of talented and respected physicians from other Latin American countries and the U.S. to provide state-of-the-art patient treatment and follow-up under the Regenestem brand.

Regenestem currently offers stem cell treatments for arthritis, autism, chronic obstructive pulmonary disease (COPD), diabetes and multiple sclerosis at various facilities including Far Eastern University in Manila, Philippines, University of Nuevo Leon (University Hospital) in Monterrey, Mexico, and University Maimonides in Buenos Aires, Argentina.

Committed to the highest of standards in service and technology, expert and compassionate care, and a philosophy of exceeding the expectations of its international patients, Regenestem provides an international staff and one-stop, cutting-edge cellular therapies focused on patient treatment.

All Regenestem facilities are certified for the medical tourism market, and staff physicians are board-certified or board-eligible and provide services in more than 10 specialties, attracting patients from the United States and around the world.

For more information, visit the Regenestem website, email info(at)regenstem(dot)com, or call 305-224-1858.

About Regenestem:

Regenestem, a division of the Global Stem Cells Group, Inc., is an international medical practice association committed to researching and producing comprehensive stem cell treatments for patients worldwide. Having assembled a highly qualified staff of medical specialistsprofessionals trained in the latest cutting-edge techniques in cellular medicineRegenestem continues to be a leader in delivering the latest protocols in the adult stem cell arena.

About the Global Stem Cell Group:

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Regenestem Announces Plans to Create a Stem Cell Treatment Center in Collaboration with CMC Hospital Group in Cozumel ...

Global Stem Cells Group, Inc. Announces Worldwide Alliance with EmCyte Corp. to Promote In-office Regenerative …

MIAMI (PRWEB) October 01, 2013

The Global Stem Cells Group, Inc. has announced a worldwide alliance with Fort Myers, Florida-based EmCyte Corporation to promote in- office regenerative medicine procedures for physicians and practitioners.

EmCyte, a leading provider of biotechnology solutions in the United States, develops biological products for platelet rich plasma and bone marrow concentrate grafting procedures. The company also manufactures proprietary devices designed for harvesting the patients own plasma or bone marrow to use for the patients treatment.

EmCyte provides clinical support and trains physicians in using biologics for sports and general rehabilitative procedures. EmCyte is now seeking to expand its operations trough the Global Stem Cells Group Network.

The Global Stem Cells Groups collaboration with EmCyte is a logical one, as both companies are committed to research and development of products and procedures that will bring stem cell treatments to patients right in the physicians office.

Through its six separate stem cell companies, Global Stem Cell Group is dedicated to finding opportunities like the EmCyte alliance that help expand the reach of stem cell therapy to all patients who can benefit from it.

For more information on stem cell research, products and therapies, visit the Global Stem Cell Group website, email bnovas(at)regenestem(dot)com, or call 305-224-1858.

About the Global Stem Cell Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions. With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Groups corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCGs six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

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Global Stem Cells Group, Inc. Announces Worldwide Alliance with EmCyte Corp. to Promote In-office Regenerative ...

Southern California Stem Cell Therapy Clinic, TeleHealth, Now Offering Stem Cells for Knee Arthritis

Orange, CA (PRWEB) September 30, 2013

TeleHealth, the leading stem cell therapy clinic on the West Coast, is now offering multiple treatments with stem cells for knee arthritis. The stem cell treatments are very exciting as they present the possibility of repairing and regenerating arthritis damage in the knees. The treatments are offered by Board Certified stem cell doctors at the clinic in outpatient, low risk procedures that are often covered by insurance. Call (888) 828-4575 for more information and scheduling.

Over the past few years, increasing studies are showing the benefits of regenerative medicine treatments for knee arthritis. This includes a study out of the Hospital for Special Surgery last year showing effectiveness of platelet rich plasma therapy for knee arthritis. Treatment options at TeleHealth include both platelet rich plasma therapy (PRP therapy) along with bone marrow derived stem cell injection therapy or fat derived stem cell therapy.

Often, the treatments are combined to produce maximum knee arthritis benefit and allow patients to avoid surgery, reduce pain and dramatically increase functional ability. While knee replacement surgery has been shown to have a high success rate, the components are not meant to last forever and there can be complications with the surgery.

Therefore, it makes sense to try conservative treatment prior such as with the regenerative medicine options at TeleHealth. Especially considering the stem cell treatments are often covered by insurance.

TeleHealths main stem cell clinic is located in Orange, CA, convenient to major freeways and not far from San Diego, Los Angeles, Santa Ana and Inland Empire. The highly skilled stem cell doctors at the clinic are Board Certified and have years of experience treating musculoskeletal conditions with stem cell treatments including shoulder arthritis, rotator cuff tendonitis, Achilles tendonitis, tennis elbow, muscle tears and much more.

Call (888) 828-4575 for more information and scheduling.

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Southern California Stem Cell Therapy Clinic, TeleHealth, Now Offering Stem Cells for Knee Arthritis

Trial to determine if stem cells can help with rare lung disease

Jose Guzman began gasping for breath while using his treadmill on the lowest setting and knew something was wrong. His search for answers led him to the diagnosis of a rare lung disease with no cure.

Guzman, 72, who arrived from Cuba penniless and built a thriving Miami travel agency, doesnt give up easily. He has signed on to be one of the first patients to participate in a clinical trial being launched at the University of Miami. Dr. Marilyn Glassberg has obtained approval from the Food and Drug Administration to launch the first U.S. clinical trial that will test whether mesenchymal stem cells given intravenously could be a therapy for patients with Guzmans rare lung disease, known as idiopathic pulmonary fibrosis. The disease strikes mostly men who are 55 and older and ex-smokers.

Glassberg, a pulmonologist and professor of medicine and surgery and director of the pulmonary division at the Interdisciplinary Stem Cell Institute at UMs Miller School of Medicine, has studied rare lung diseases for 20 years. She says this is her first real hope of extending or improving the lives of her patients who have this progressive and fatal lung disease, which often leads to death within five years of diagnosis.

Glassberg says it if successful, stem cells could be applied as a potential therapy for other, more common lung diseases such as asthma or emphysema.

We believe moving cell-based therapies to diseases like these make sense, Glassberg says.

For the clinical trial, Glassberg says she chose to first focus on a lung disease with the worst prognosis.

Once fibrosis is present, it is the end stage because the damaged cells dont know how to repair themselves, she explains. Our hope is that the stems cells will curb the acceleration.

The trials results could change the way doctors manage lung disease for patients and get them away from drugs that have not been effective, she said.

The idea for using intravenous mesenchymal stem cells as a treatment for lung disease came from the work of several researchers, including a UM colleague who had used stem cell therapies on cardiac patients, Glassberg says. While reading a report on Dr. Joshua Hares 2009 study that used stem cells to repair heart damage, Glassberg said she was struck by one of its findings: the cells infused into the heart noticeably improved lung function, too.

The probability made sense to Glassberg because the lungs are the first stop for injected stem cells, regardless of where they are targeted. She became convinced she should try to apply this therapy to the pulmonary disease that has frustrated her for more than a decade.

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Trial to determine if stem cells can help with rare lung disease

Patient's own cells might be used as treatment for Parkinson's disease

Sep. 26, 2013 Induced pluripotent stem cells (iPSCs) taken from a patient hold great therapeutic potential for many diseases. However, studies in rodents have suggested that the body may mount an immune response and destroy cells derived from iPSCs. New research in monkeys refutes these findings, suggesting that in primates like us, such cells will not be rejected by the immune system. In the paper, publishing September 26 in the ISSCR's journal Stem Cell Reports, published by Cell Press, iPSCs from nonhuman primates successfully developed into the neurons depleted by Parkinson's disease while eliciting only a minimal immune response. The cells therefore could hold promise for successful transplantation in humans.

iPSCs are cells that have been genetically reprogrammed to an embryonic stem-cell-like state, meaning that they can differentiate into virtually any of the body's different cell types. iPSCs directed to differentiate into specific cell types offer the possibility of a renewable source of replacement cells and tissues to treat ailments, including Parkinson's disease, spinal cord injury, heart disease, diabetes, and arthritis.

Studies in rodents have suggested that iPSC-derived cells used for transplantation may be rejected by the body's immune system. To test this in an animal that is more closely related to humans, investigators in Japan directed iPSCs taken from a monkey to develop into certain neurons that are depleted in Parkinson's disease patients. When they were injected into the same monkey's brain (called an autologous transplantation), the neurons elicited only a minimal immune response. In contrast, injections of the cells into immunologically unmatched recipients (called an allogeneic transplantation) caused the body to mount a stronger immune response.

"These findings give a rationale to start autologous transplantation -- at least of neural cells -- in clinical situations," says senior author Dr. Jun Takahashi, of the Kyoto University's Center for iPS Cell Research and Application. The team's work also suggests that transplantation of such neurons into immunologically matched recipients may be possible with minimal use of immunosuppressive drugs.

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Patient's own cells might be used as treatment for Parkinson's disease