News Article | May 5, 2017
This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials. Kelly Scientific analysis indicates that the global regenerative medicine market was worth $18.9 billion in 2016 and will grow to over $53.7 billion by 2021. Within this market, the stem cell industry will grow significantly. Regenerative medicine's main objective is to heal and replace organs/cells that have been damaged by age, trauma or disease. Congenital defects can also be addressed with regenerative medicine. Therefore, it's market encompasses dermal wounds, cardiovascular disease, specific cancer types and organ replacement. To that end, regenerative medicine is a broader field and manipulates the body's immune system and regeneration potential to achieve its requirement. Financially speaking, investment into this space is dominated by grants, private investors and publicly traded stocks. Looking forward, the regenerative medicine market is promising for a number of robust reasons including: Key Topics Covered: 1.0 Report Synopsis 2.0 Introduction 2.1 Gurdon and Yamanaka Share the Nobel Prize 2.2 Stem Cell Clinical Trials: Initiated in 2010 2.3 Types of Stem Cells 2.4 Adult (Tissue) Stem Cells 2.5 Pluripotent Stem Cells 2.6 Somatic Cell Nuclear Transfer (SCNT) 2.7 Induced pluripotent Stem Cells (iPSC) 2.8 Mesenchymal Cells 2.9 Hematopoietic Stem and Progenitor Cells 2.10 Umbilical Cord Stem Cells 2.11 Heart Stem Cells 2.12 Mammary Stem Cells 2.13 Neural Stem Cells 2.14 Stem Cell Applications in Retinal Repair 2.15 Liver Stem Cells 2.16 Gut Stem Cells 2.16 Pancreatic Stem Cells 2.17 Epidermal Stem Cells 3.0 Stem Cells and Clinical Trials 3.1 Introduction 3.2 Pluripotent Stem Cells 3.3 Limbal Stem Cells 3.4 Neural Stem Cells 3.5 Endothelial Stem or Progenitor Cells 3.6 Placental Stem Cells 3.7 Why Do Stem Cell Clinical Trials Fail? 3.8 What is the Future of Stem Cell Trials? 3.9 Cutting Edge Stem Cell Clinical Trials 3.10 Ocata Therapeutics Current Stem Cell Trials 3.11 CHA Biotech Current Stem Cell Trials 3.12 Pfizer Current Stem Cell Trials 3.13 GSK Current Stem Cell Trials 3.14 Bayer Current Stem Cell Trials 3.15 Mesoblast International Current Stem Cell Trials 3.16 Millennium Pharmaceutical Current Stem Cell Trial 3.17 AstraZeneca Current Stem Cell Trials 3.18 Merck Current Stem Cell Trials 3.19 Chimerix Current Stem Cell Trials 3.20 Eisai Current Stem Cell Trials 3.21 SanBio Current Stem Cell Trials 3.22 Celgene Current Stem Cell Trials 3.23 StemCells Current Stem Cell Trials 3.24 Genzyme (Sanofi) Current Stem Cell Trials 3.25 Teva Current Stem Cell Trials 3.26 MedImmune Current Stem Cell Trials 3.27 Janssen Current Stem Cell Trials 3.28 Seattle Genetics Current Stem Cell Trials 3.29 Baxter Healthcare Current Stem Cell Trials 3.30 InCyte Corp Current Stem Cell Trials 4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing 4.1 Introduction 4.2 Case Study: Genentech and Stem Cell Technology 4.3 3D Sphere Culture Systems 4.4 Stem Cells and High Throughput Screening 4.5 Genetic Instability of Stem Cells 4.6 Comprehensive in Vitro Proarrhythmia Assay (CiPA) & Cardiomyocytes 4.8 Coupling Precise Genome Editing (PGE) and iPSCs 4.9 Stem Cells & Toxicity Testing 4.10 Stem Cell Disease Models 4.11 Defining Human Disease Specific Phenotypes 4.12 Advantages of Stem Cell Derived Cells & Tissues for Drug Screening 5.0 Stem Cell Biomarkers 5.1 Pluripotent Stem Cell Biomarkers 5.2 Mesenchymal Stem Cell Biomarkers 5.3 Neural Stem Cell Biomarkers 5.4 Hematopoietic Stem Cell Biomarkers 6.0 Manufacturing Stem Cell Products 6.1 Manufacturing Strategies For Stem Cell Products 6.2 BioProcess Economics for Stem Cell Products 6.3 Capital Investment 6.4 Cost of Goods 6.5 Bioprocess Economic Drivers & Strategies 6.6 hPSC Expansion & Differentiation using Planar Technology 6.7 hPSC Expansion using 3D Culture 6.8 Microcarrier Systems 6.9 Aggregate Suspension 6.10 Bioreactor Based Differentiation Strategy 6.11 Integrated hPSC Bioprocess Strategy 6.12 GMP Regulations and Stem Cell Products 7.0 Investment & Funding 7.1 What do Investors Want from Cell & Gene Therapy Companies? 7.2 What Makes a Good Investment? 7.3 What Types of Companies do Not Get Investment? 7.4 Global Funding 7.5 Cell & Gene Therapy Investment Going Forward 7.6 What Cell & Gene Companies are the Most Promising in 2017? 7.7 Insights into Investing in Cell and Gene Therapy Companies 8.0 Regenerative Medicine Market Analysis & Forecast to 2021 8.1 Market Overview 8.2 Global Frequency Analysis 8.3 Economics of Regenerative Medicine 8.4 Market Applications & Opportunities for Regenerative Therapies 8.5 Global Financial Landscape 8.6 Regenerative Medicine Clinical Trial Statistics 8.7 Regenerative Medicine Market Forecast to 2021 8.8 Regenerative Medicine Geographic Analysis and Forecast to 2021 8.9 Regenerative Medicine Geographical Location of Companies 8.10 Regenerative Medicine Technology Breakdown of Companies 8.11 Commercially Available Regenerative Medicine Products 8.12 Major Regenerative Medicine Milestones 9.0 Stem Cell Market Analysis & Forecast to 2021 9.1 Autologous & Allogenic Cell Market Analysis 9.2 Stem Cell Market by Geography 9.3 Stem Cell Market Forecast by Therapeutic Indication 9.4 Stem Cell Reagent Market Trends 10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2021 10.1 Geographical Analysis and Forecast to 2021 10.2 Geographical Analysis by Company Share 10.3 Tissue Engineering Clinical Indication Analysis & Forecast to 2021 11.0 Biobanking Market Analysis 11.1 Increasing Number of Cord Blood Banks Globally 11.2 Global Biobanking Company Sector Analysis & Breakdown 11.3 Allogenic Versus Autologous Transplant Frequency 11.4 Biobanking Market Analysis & Forecast to 2021 11.5 Major Global Players 12.0 Global Access & Challenges of the Regenerative Medicine Market 12.1 Regenerative Medicine Market in the USA 12.2 Regenerative Medicine in Japan 12.3 Regenerative Medicine in China 12.4 Regenerative Medicine in South Korea 13.0 Cell and CAR T Therapy 13.1 Challenges Relating to Cell therapy and Chimeric Antigen Receptor T Cells in Immunotherapy 13.2 Regulations Pertaining to Immunotherapy, including Adoptive Cell Therapy (CAR-T and TCR) Immunotherapy Regulation in the USA 13.3 Regulations for Cell Therapy & Immunotherapy in Japan 13.4 European Regulation and Cell Therapy & Immunotherapeutics 13.5 Manufacturing of Immunotherapies 13.6 Supply Chain & Logistics 13.7 Pricing & Cost Analysis 14.0 Company Profiles 14.1 Astellas Institute for Regenerative Medicine (Ocata Therapeutics) 14.2 Athersys 14.3 Baxter International (Baxalta, Shire) 14.4 Caladrius Biosciences (NeoStem) 14.5 Cynata Therapeutics 14.6 Cytori Therapeutics 14.7 MEDIPOST 14.8 Mesoblast 14.9 NuVasive 14.10 Osiris Therapeutics 14.11 Plasticell 14.12 Pluristem Therapeutics 14.13 Pfizer 14.14 StemCells Inc 14.15 STEMCELL Technologies 14.16 Takara Bio 14.17 Tigenix 15.0 SWOT Industry Analysis 15.1 What has Strengthened the Industry Thus Far? 15.2 Allogenic and Autologous Stem Cell Industry SWOT Analysis 15.3 What are the Main Driving Forces of this Space? 15.4 Restraints of the Regenerative Medicine Industry as a Whole 15.5 Industry Opportunities Within this Sector 15.6 USA SWOT Analysis 15.7 UK SWOT Analysis 15.8 South Korea SWOT Analysis 15.9 China SWOT Analysis 15.10 Japan SWOT Analysis 15.11 Singapore SWOT Analysis For more information about this report visit http://www.researchandmarkets.com/research/jh2432/global To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-regenerative-medicine-market-analysis--forecast-2017-2021---research-and-markets-300452299.html
News Article | March 2, 2017
A new study published this month in STEM CELLS Translational Medicine indicates that treating heart patients with mesenchymal stem cells (MSCs) does not increase their risk of irregular heart beat (arrhythmia). In fact, the MSCs had the opposite effect and showed promise of improving the condition. “This could be an important breakthrough for many heart patients, as proarrhythmia – which is a new or more frequent occurrence of pre-existing arrhythmia – unfortunately can be a side effect of some of the drugs we’re using to treat these patients,” said the study’s lead author, Raul Mitrani, M.D., of the University of Miami School of Medicine’s Division of Cardiology (Miami, Florida). Arrhythmia is a common condition resulting when electrical impulses in the heart do not work properly, causing the heart to beat either too fast, too slow or erratically. This in turn interferes with blood flow throughout the body and can potentially damage or shut down organs. While some experience no symptoms and their arrhythmia is harmless, in others it can be life threatening. Treatments include anti-arrhythmic drugs; implantable devices such as a pacemaker; surgery; or catheter ablation (a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing the off-kilter beats). As more studies are showing the potential of stem cells to repair damage caused by heart disease, Dr. Mitrani and his colleagues at UM wondered whether the stem cells – specifically MSCs, which are 'adult' stem cells that can produce more than one type of specialized cell of the body – would follow the path of some of the anti-arrhythmia drugs and worsen the condition. Previous studies had indicated that perhaps was the case with certain other types of stem cells, but no studies had focused on MSCs. To find the answer, they analyzed the results of 88 patients enrolled in two clinical trials testing the potential of MSCs in treating ischemic cardiomyopathy. This is a common condition in which the heart's ability to pump blood is decreased because its main pumping chamber, the left ventricle, is enlarged, dilated and weak. The patients had an average age of 61 years and were divided into groups treated with either MSCs, bone marrow stem cells (BMCs) or placebo. A year after their treatments, those who received MSCs all showed no signs of arrhythmia. “We were encouraged by what we saw,” Dr. Mitrani said. “Even better, in a group of patients with low ventricular ectopy burden – what some call ‘heart hiccups’ or ‘skipped beats’ – there were definite signs of improvement while in the BMC and placebo groups, no similar signal for improvement was noted. “This leads us to believe that prospective studies might clarify the role of MSCs to reduce ventricular arrhythmias.” “By combining data from two studies, the authors were able to study this question in one of the largest groups of patients to date,” said Anthony Atala, Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. “These findings are important because they emphasize the need for further large prospective studies to evaluate the anti-arrhythmic potential of mesenchymal and other newer cell-based therapies.” The full article, “Effects of Transendocardial Stem Cell Injection on Ventricular Proarrhythmia in Patients with Ischemic Cardiomyopathy: Results from the POSEIDON and TAC-HFT Trials,” can be accessed at: http://onlinelibrary.wiley.com/doi/10.1002/sctm.16-0328/full. About STEM CELLS Translational Medicine: STEM CELLS Translational Medicine (SCTM), published by AlphaMed Press, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices. About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS® (http://www.StemCells.com), celebrating its 35th year, is the world's first journal devoted to this fast paced field of research. The Oncologist® (http://www.TheOncologist.com), also a monthly peer-reviewed publication, entering its 22nd year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.
News Article | November 28, 2016
HINGHAM, Mass., Nov. 28, 2016 (GLOBE NEWSWIRE) -- Microbot Medical Ltd., a medical device company specializing in the research, design and development of transformational micro-robotic medical technologies, today announced that it has closed its merger transaction with StemCells, Inc. (Nasdaq:STEM), pursuant to which Microbot became a wholly-owned subsidiary of StemCells, Inc. StemCells will be renamed Microbot Medical Inc. and will begin trading on NASDAQ under the symbol ‘MBOT’ on November 29, 2016. “Microbot Medical’s founding principle is to improve the quality of life of millions of patients globally by advancing micro-robotic technologies to perform surgical procedures within the human body, and offer physicians and their patients less invasive and more precise solutions. Our vision, which helped guide the development of multiple products based on our unique ViRob and TipCAT micro-robotic technology platforms, is becoming a reality as our lead product candidates for Cerebrospinal Fluid (CSF) and Gastrointestinal (GI) Disorders continue to progress,” commented Harel Gadot, Chairman and Chief Executive Officer of Microbot Medical. “The completion of this merger is a significant milestone and enables us to capitalize on Microbot Medical’s unique core capabilities and fund our next generation of micro-robotic medical products. We anticipate FDA submission for these products in the near future, and once commercialized, our robust pipeline is expected to deliver a succession of new product launches and applications driving our short, mid and long term revenue prospects,” concluded Mr. Gadot. Following the completion of the merger and one–for-nine reverse stock split, there are approximately 39 million shares of common stock outstanding. Under the terms of the merger agreement with StemCells, the shareholders of Microbot Medical, and certain advisors and consultants with respect to the merger, received shares of StemCells common stock representing approximately 95% of the outstanding shares of StemCells calculated on a fully diluted basis. Stockholders of StemCells prior to the merger have retained approximately 5% of the company. Microbot’s leadership includes Mr. Gadot, a co-founder who previously served as a Worldwide Group Marketing Director at Johnson & Johnson’s surgical device company Ethicon Inc. Additionally, Prof. Moshe Shoham, an inventor of Microbot’s technologies and a co-founder of the Company will remain on the Board of Directors and the company’s Scientific Advisory Board. Professor Shoham also founded Mazor Robotics Ltd. The current members of the Board of Directors of Microbot Medical will serve on the Board of Directors of the company, with the addition of Scott Burell, a seasoned public company executive who currently serves as Chief Financial Officer, Secretary and Treasurer of CombiMatrix Corporation. The Company’s corporate headquarters will be located in Hingham, Massachusetts and Yokneam, Israel. Microbot Medical is a medical device company specializing in the design and development of transformational micro-robotic medical technologies. The Company is primarily focused on leveraging its micro-robotic technologies with the goal of allowing more physicians to treat more patients while improving surgical outcomes for patients. The Company is currently developing its first two product candidates: the Self Cleaning Shunt, or SCS, for the treatment of hydrocephalus and Normal Pressure Hydrocephalus, or NPH; and TipCAT, a self-propelling, semi-disposable endoscope that is being developed initially for use in colonoscopy procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. 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” and “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, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, 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 businesses of Microbot Medical Inc. particularly those mentioned in the cautionary statements found in Microbot Medical Inc.’s filings with the Securities and Exchange Commission. Microbot Medical Inc. disclaims any intent or obligation to update these forward-looking statements.
News Article | December 7, 2016
Two years after having a stroke at 31, Sonia Olea Coontz remained partially paralysed on her right side. She could barely move her arm, had slurred speech and needed a wheelchair to get around. In 2013, Coontz enrolled in a small clinical trial. The day after a doctor injected stem cells around the site of her stroke, she was able to lift her arm up over her head and speak clearly. Now she no longer uses a wheelchair and, at 36, is pregnant with her first child. Coontz is one of stem-cell therapy's “miracle patients”, says Gary Steinberg, chair of neurosurgery at Stanford School of Medicine in California, and Coontz's doctor. Conventional wisdom said that her response was impossible: the neural circuits damaged by the stroke were dead. Most neuroscientists believed that the window for functional recovery extends to only six months after the injury. Stem-cell therapies have shown great promise in the repair of brain and spinal injuries in animals. But animal models often behave differently from humans — nervous-system injuries in rats, for example, heal more readily than they do in people. Clinical trial results have been mixed. Interesting signals from small trials have faded away in larger ones. There are plenty of unknowns: which stem cells are the right ones to use, what the cells are doing when they work and how soon after an injury they can be used. The field is still young. Stem cells are poorly understood, and so is what happens after a spinal-cord injury or stroke. Yet, there are success stories, such as Coontz's, which seem to show that therapy using the right sort of stem cell can lead to functional improvements when tried in the right patients and at the right time following an injury. Researchers are fired up to determine whether stem-cell therapies can help people who are paralysed to regain some speech and motor control — and if so, what exactly is going on. Neurologists seeking functional restoration are up against the limited ability of the human central nervous system to heal. The biology of the brain and spinal cord seems to work against neuroregeneration, possibly because overgrowth of nerves could lead to faulty connections in the finely patterned architecture of the brain and spine, says Mark Tuszynski, a neurologist at the University of California, San Diego. Local chemical signals in the central nervous system tamp down growth. Over time, scarring develops, which prevents the injury from spreading, but also keeps cells from entering the site. “It's really hard to fix the biology,” says Charles Yu Liu, a neurosurgeon and director of the University of Southern California Neurorestoration Center in Los Angeles. Stem cells seem to promise a workaround. So far, neural regeneration cell therapy has had only anecdotal success, leaving investors and patients disappointed. In people with Parkinson's disease, for example, neurosurgeons replaced dead and dying dopamine-producing neurons with fetal neurons. Although initial results were promising, in larger studies, patients reported involuntary movements. Another effort tried treating people who'd had a stroke with cells derived from tumours; the results were mixed, and researchers were uneasy about the cells' cancerous source. In recent years, researchers have had success with stem cells coaxed to develop into particular cell types, such as neural support cells. Tuszynski has showed how well stem cells can work — at least, in animal models1. His group implanted neural stem cells derived from human fetal tissue into rats with severe spinal-cord injuries. Seven weeks later, the cells had bridged the gap where the spinal cord had been cut and the animals were able to walk again. The cells used in the study were manufactured by Neuralstem of Rockville, Maryland. The group has shown that other kinds of stem cell, including those derived from adult tissue, also work. Tuszynski has seen similar results in a rat spinal-cord-injury model, using neural stem cells made from the tissues of a healthy 86-year-old volunteer2. But animal studies are also making it clear that simply regrowing the connective wiring of the nervous system to bridge damaged areas is not enough, says Zhigang He, who studies neural repair at the Harvard Stem Cell Institute in Cambridge, Massachusetts. No matter what the animal model is, he says, the axons don't always grow into the right places. It's not enough to have a nerve, that nerve must become part of a functional circuit. There is growing evidence that besides becoming replacement nerves, stem cells perform other functions — they also seem to generate a supportive milieu that may encourage the natural recovery process or prevent further damage after an injury. Many types of neural stem cell secrete a mix of molecules that unlock suppressed growth pathways in nerves. Earlier this year, Tuszynski reported that any sort of spinal-cord stem cell, whether derived from adult tissues or embryos, from humans, rats or mice, could trigger native neural regeneration in rats3. But his success in rats has not yet translated into clinical trials. More work is needed, Tuszynski says, to determine which type of cell will work best for which particular injury. For people who have had a stroke or spinal-cord injury, physical therapy is currently the best hope for recovery in the weeks and months after the injury. The brain is plastic and can co-opt other circuits and pathways to compensate for damage and to restore function. Once the inflammation ebbs and the brain adjusts, people can start to regain function. But the window of opportunity is short. Most people don't make functional gains after six months. That timeline is why the remarkable recovery enjoyed by Coontz and other patients with chronic stroke in the same clinical trial is so surprising, says Steinberg. “This changes our whole notion of recovery,” he says. There were 18 people in the trial Coontz took part in, and all were treated using stem cells manufactured by SanBio of Mountain View, California. The company's cells are bone-marrow-derived mesenchymal stem cells. The cells are treated with a DNA fragment that is transiently expressed in them, and causes changes in their protein-expression patterns. In animal studies, these cells promote the migration and growth of native neural stem cells, among other effects. The trial, which was designed to look at safety as well as efficacy, recruited patients after an ischaemic stroke. During this kind of stroke, a clot cuts off the blood supply to part of the brain, causing significant damage. Patients in the trial had all had ischaemic strokes deep in the brain 7–36 months earlier — past the 6-month window for significant recovery. Each patient was injected with either 2.5 million, 5 million or 10 million of SanBio's cells4. Steinberg has followed participants for 24 months; an interim study at 12 months reported that most patients showed functional improvements. Some, like Coontz, achieved almost complete recovery. What is not clear, however, is what the stem-cell injections do in the brain. In animal studies, the SanBio cells do not turn into neurons, but seem to send supporting signals to native cells in the brain. Indeed, preclinical research shows that the cells do not integrate into the brain — most die after 12 months. Instead, the cells seem to secrete growth factors that encourage the formation of new neurons and blood vessels, and foster connections called synapses between neurons. And in rats, the nerve-cell connections that extended from one side of the brain to the other, as well as into the spinal cord, lasted, even though the injected cells did not4. But these mechanisms are not sufficient to explain Coontz's overnight restoration of function, says Steinberg. He is entertaining several hypotheses, including that the needle used to deliver the cells may have had some effect. “One week after treatment, we saw abnormalities in the premotor cortex that went away after one month,” he says. The size of these microlesions was strongly correlated with recovery at 12 months. A similar effect can happen when electrodes are implanted in the brains of people with Parkinson's, although this deep-brain stimulation quietens tremors for only a short time. The people who'd had a stroke had a lasting recovery, suggesting that both the needle and the stem cells may have played a part. The SanBio trial was small, and did not have a placebo control; the company is now recruiting for a larger phase II trial. Of the 156 participants that will be recruited, two-thirds will have cells injected — the others will have a sham surgery. Even the trial surgeons, including Steinberg, will not know who is getting which treatment. The main outcome measure will be whether patients' motor-skill scores improve on a test called the Fugl-Meyer Motor scale six months after treatment. Participants will be monitored for at least 12 months, and will also be evaluated with tests that look for changes in gait and dexterity. Meanwhile, Steinberg plans to study microlesions in animal models of stroke to determine whether they do have a role in recovery. An ongoing clinical trial evaluating escalating doses of neural stem cells in patients with acute spinal-cord injuries is also looking promising. Asterias Biotherapeutics of Fremont, California, coaxes the cells to develop into progenitors of oligodendrocytes, a type of support cell that's found in the brain and spinal cord and that creates a protective insulation for neuronal axons. The trial tests the safety and efficacy of administering these cells to people with recent cervical, or neck-level, spinal-cord injury. Interim results for patients who had received the two lower doses were presented at the International Spinal Cord Society meeting in September. After 90 days, 4 patients who received 10 million cells showed improved motor function; a fifth patient had not reached the 90-day mark yet. At one year, the three patients receiving a lower dose of two million cells showed measurable improvement in motor skills. These cells were initially developed by Geron, a biotechnology company that has since moved away from regenerative medicine. Before spinning out Asterias in 2013, Geron had run a safety trial of the cells in people with a chronic lower-back injury. No issues were identified, and the US Food and Drug Administration agreed to let the company test the cells in patients who'd been recently injured. Asterias focused the current trial on patients with cervical injuries because these are closer to the brain, so new nerve cells have a shorter distance to grow to gain functional improvements. People with severe cervical spine injuries are typically paralysed below the level of the damage. The company's hope is to restore arm and hand function for people with such injuries, potentially making a tremendous difference to a person's independence and quality of life. Asterias seems to have realized this hope in at least one patient who received one of the higher doses. Kristopher Boesen, who is 21, has had a dramatic recovery. In March, Boesen's car fishtailed in a rainstorm; he hit a telephone pole and broke his neck. About a month later, Boesen was still paralysed below the injury, and his neurological improvements seemed to have plateaued. His doctors at a trauma centre in Bakersfield, California, were in touch with Liu, who is an investigator in the Asterias trial. As soon as he was stable, Boesen travelled to Los Angeles to join the trial. Liu injected Boesen's spinal cord with Asterias's cells in April. Two days later, Boesen started to move his hands, and in the summer, he regained the ability to move the toes on one foot. Liu is excited about Boesen's response. “He was looking at being quadriplegic, and now he's able to write, lift some weights with his hands, and use his phone,” says Liu. “For somebody to improve like this is highly unusual — I want to be jumping out of my shoes.” But Liu cautions that this is still a small trial, and that Boesen's response is just one anecdotal report. Until the results are borne out in a large, placebo-controlled clinical trial, Liu will remain earthbound. The trial is currently recruiting between 5 and 8 patients for another cohort that will receive a doubled dose of 20 million cells. As the trial goes on, Asterias hopes to find clues about the underlying mechanism. “We're looking at changes in the anatomy of the injury,” says the company's chief scientific officer, Jane Lebkowski. She says that there is some evidence that axons have traversed the injury site in patients who have recovered function. Preclinical work suggests that the cells might be sending growth-encouraging chemical signals to the native tissue. And, as support cells, the astrocytes may also be preventing more neurons from dying in the aftermath of the acute spinal injury. Not all clinical trials have performed so well. The SanBio and Asterias results are positive signals in a sea of negative or mixed trials. For example, StemCells of Newark, California, terminated its phase II trial of stem cells for the treatment of spinal-cord injury in May, and shortly afterwards announced that it will restructure its business. The company declined to comment for this article. Physicians such as Liu and Steinberg temper their public enthusiasm about stem-cell therapies, so as not to give false hope to desperate patients. People with paralysing injuries or those who have a neurodegenerative disease are easy marks for unscrupulous stem-cell clinics, whose therapies are not only unproven, but also come with risks. “Patients say, 'Go ahead, doc, you can't make me any worse,'” says Keith Tansey, a neurologist and researcher at the Methodist Rehabilitation Center in Jackson, Mississippi, and president-elect of the American Spinal Injury Association. Unfortunately, that is not the case. Cell therapies given at a clinic, outside the context of a clinical trial, can lead to chronic pain, take away what little function a patient has left and render a patient ineligible for future studies, says Tansey. He has seen the consequences in his clinical practice. “I treated a kid who had two different tumours in his spinal cord from two different individuals' cells,” he says. Many unanswered questions remain about whether stem cells can heal the central nervous system in people, and how they might do it. Researchers also don't know what cells are the best to use. Is it enough for them to grow into supportive cells that send friendly growth signals, or is it better that they grow into replacement neurons? The answer is likely to differ depending on the site and nature of the disease or injury. If the stem cells are producing supportive factors that encourage growth and repair, it might be possible, says He, to discern what these are and give them directly to patients. But biologists are not yet close to deciphering the recipe for such a cocktail. Tansey agrees that there are many unknowns — and these seem to be multiplying. “Every time we get an experiment done we realize it's more complex than we thought it would be,” he says. Tansey thinks that the best way to resolve such uncertainties is with carefully regulated clinical trials. Rat models will only tell us so much — the human nervous system is much larger and is wired differently. If stem cells help patients such as Coontz and Boesen to regain their speech and give them greater independence without adverse effects, then it makes sense to continue, he says, even without knowing all the details of how they work. Until these positive, but small, results are replicated in larger, controlled clinical trials, neurologists are containing their optimism. “I'd like to hear of any clinical trial that has more than an anecdotal benefit,” says Tansey. And Liu is anticipating the day when he won't need to control his elation. In a few years, perhaps there will be a genuine opportunity to jump for joy.
News Article | October 27, 2016
NEWARK, Calif., Oct. 27, 2016 (GLOBE NEWSWIRE) -- StemCells, Inc. (NASDAQ:STEM) reported today that four of the five proposals presented at the stockholder meeting in connection with the Company’s planned merger transaction with Microbot Medical Ltd. (Microbot) were approved yesterday. The first proposal – to approve and adopt the Agreement and Plan of Merger and Reorganization with Microbot – was not taken up for vote at the meeting because an insufficient number of shares had so far been voted on the proposal. It is highly important for ALL Company stockholders to exercise a vote on Proposal #1 to approve the Microbot merger agreement. Company stockholders of record as of September 20, 2016 are encouraged to return proxies as soon as possible by mail, or vote online, as instructed in the proxy mailings delivered on or around October 3, 2016. If you did not receive proxy materials, please contact the Company’s proxy solicitor, Okapi Partners, at 877-259-6290. As of yesterday’s meeting date, approximately 3.8 million shares had been voted on Proposal #1 to approve the Microbot merger agreement, or approximately 24% of the Company’s shares eligible to vote, with 95.97% of these shares voting in favor of the proposal, 2.10% voting against, and 1.91% abstaining. The Company’s stockholders approved proposal #2 (to approve the issuance of shares to Microbot’s shareholders and advisors in accordance with the merger agreement), proposal #3 (to amend the Company’s charter to effect a reverse stock split), proposal #4 (to amend the Company’s charter to increase its authorized capital), and proposal #5 (to change the Company’s corporate name in connection with the proposed merger to Microbot Medical Inc.). Each of these four stockholder proposals passed with an approval of approximately 85% of the votes cast or higher. The special stockholder meeting has been adjourned in order to collect additional votes on Proposal #1. The Company’s special stockholder meeting will resume on November 14, 2016, at 10:00am, Pacific Time, at 650 California Ave, Suite 1900, San Francisco, CA. Between now and the November 14, 2016 adjournment date, the Company will intensify its outreach to existing stockholders to encourage their participation in the vote being taken. “We are certainly pleased to see considerable progress towards completing all of the preclosing conditions for the Microbot deal, including yesterday’s stockholder vote, and to receive such broad support from our existing stockholders,” commented Mr. Ken Stratton, President and General Counsel of StemCells, Inc. “Our Board has unanimously approved and recommended the Microbot deal as being in the best interests of our stakeholders. We will take all reasonable steps to ensure sufficient votes are cast by November 14 to be in a position to successfully close the merger soon thereafter.” Further information about StemCells, Inc. is available at http://www.stemcellsinc.com. Ropes & Gray LLP acted as legal advisor to StemCells and Ruskin Moscou Faltischek, P.C. and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. acted as legal advisor to Microbot. Additional information about the proposed transaction can be found in the Form 8‑K filed by StemCells on August 15, 2016. Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the future business operations of StemCells, Inc. (the "Company"), the possibility of a merger transaction between the companies, the possibility of obtaining the vote required from the Company’s stockholders to complete the merger with Microbot, and possible benefits from such a merger for the companies and their respective stakeholders. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainties about the parties’ ability to complete the merger; uncertainties concerning the sufficiency of the Company’s remaining funds to continue operations; uncertainties regarding the Company’s plans to increase its authorized share capital; uncertainties regarding the validity and enforceability of the Company's patents and Microbot’s patents; uncertainties as to whether either company will become profitable; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2015 and the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016. A definitive proxy statement and a proxy card have been filed with the SEC and have been mailed to the Company’s stockholders seeking any required stockholder approvals in connection with the proposed transactions. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT THE COMPANY MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Stockholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by StemCells with the SEC in connection with the proposed transactions at the SEC’s website (http://www.sec.gov), at StemCells’ website, or by directing written request to: StemCells, Inc. 39899 Balentine Drive, Suite 200, Newark, CA 94560, Attention: Kenneth Stratton, Esq. The Company and its directors and executive officers and Microbot and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of the Company in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger will be included in the proxy statement referred to above. Additional information regarding the directors and executive officers of the Company is also included in the Company’s Definitive Proxy Statement on Schedule 14A relating to the 2016 Annual Meeting of Stockholders, which was filed with the SEC on April 8, 2016. This document is available free of charge at the SEC web site (www.sec.gov), at the Company’s website, or by directing a written request to the Company as described above.
News Article | November 23, 2016
The global stem cell therapy market is categorized based on various modes of treatment and by therapeutic applications. The treatment segment is further sub-segmented into autologous stem cell therapy and allogeneic stem cell therapy. The application segment includes metabolic diseases, eye diseases, immune system diseases, musculoskeletal disorders, central nervous system disorders, cardiovascular diseases and wounds and injuries. In terms of geographic, North America dominates the global stem cell therapy market due to increased research activities on stem cells. The U.S. represents the largest market for stem cell therapy followed by Canada in North America. However, Asia is expected to show high growth rates in the next five years in global stem cell therapy market due to increasing population. In addition, increasing government support by providing funds is also supporting in growth of the stem cell therapy market in Asia. China and India are expected to be the fastest growing stem cell therapy markets in Asia. In recent time, increasing prevalence of chronic diseases and increasing funds from government organizations are some of the major drivers for global stem cell therapy market. In addition, rising awareness about stem cell therapies and increasing focus on stem cell research are also supporting in growth of global stem cell therapy market. However, less developed research infrastructure for stem cell therapies and ethical issues related to embryonic stem cells are some of the major restraints for global stem cell therapy market. In addition, complexity related with the preservation of stem cell also obstructs the growth of global stem cell therapy market. Some of the major companies operating in the global stem cell therapy market are Mesoblast Ltd., Celgene Corporation, Aastrom Biosciences, Inc. and StemCells, Inc.
News Article | December 5, 2016
Stem cells are most vital cells found in both humans and non-human animals. Stem cells are also known as centerpiece of regenerative medicine. Regenerative medicines have capability to grow new cells and replace damaged and dead cells. Stem cell is the precursors of all cells in the human body. It has the ability to replicate itself and repair and replace other damaged tissues in the human body. In addition, stem cell based therapies are used in the treatment of several chronic diseases such as cancer and blood disorders. The global stem cell therapy market is categorized based on various modes of treatment and by therapeutic applications. The treatment segment is further sub-segmented into autologous stem cell therapy and allogeneic stem cell therapy. The application segment includes metabolic diseases, eye diseases, immune system diseases, musculoskeletal disorders, central nervous system disorders, cardiovascular diseases and wounds and injuries. In terms of geographic, North America dominates the global stem cell therapy market due to increased research activities on stem cells. The U.S. represents the largest market for stem cell therapy followed by Canada in North America. However, Asia is expected to show high growth rates in the next five years in global stem cell therapy market due to increasing population. In addition, increasing government support by providing funds is also supporting in growth of the stem cell therapy market in Asia. China and India are expected to be the fastest growing stem cell therapy markets in Asia. In recent time, increasing prevalence of chronic diseases and increasing funds from government organizations are some of the major drivers for global stem cell therapy market. In addition, rising awareness about stem cell therapies and increasing focus on stem cell research are also supporting in growth of global stem cell therapy market. However, less developed research infrastructure for stem cell therapies and ethical issues related to embryonic stem cells are some of the major restraints for global stem cell therapy market. In addition, complexity related with the preservation of stem cell also obstructs the growth of global stem cell therapy market. Request for Sample and Table of content Report @ : http://www.persistencemarketresearch.com/samples/3253 Some of the major companies operating in the global stem cell therapy market are Mesoblast Ltd., Celgene Corporation, Aastrom Biosciences, Inc. and StemCells, Inc.
News Article | December 1, 2016
HINGHAM, Mass., Dec. 01, 2016 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq:MBOT), a medical device company specializing in the design and development of transformational micro-robotic medical technologies, closed the previously disclosed asset purchase agreement with BOCO Silicon Valley, Inc., a wholly-owned subsidiary of Bright Oceans Corporation, for proceeds to the Company of $3,460,000. These proceeds include $255,000 which was previously paid to the Company’s predecessor, StemCells Inc., and $400,000 which will be held in escrow for 12 months to assure performance of contractual representations and warranties, but exclude consulting fees paid directly from escrow at closing to former StemCells employees involved in the asset transfer. The transferred assets included stem and progenitor cell lines that belonged to the predecessor company, StemCells, which completed a merger with the Company on November 28, 2016. The resources from the asset sale will be used to further develop the Company’s transformational micro-robotic technologies that are designed to treat and diagnose various medical conditions. The Company’s initial products are expected to address the unmet medical needs for Cerebrospinal Fluid (CSF) and Gastrointestinal (GI), and are expected to be submitted the FDA in the near future. “The proceeds enhance our balance sheet in a non-dilutive manner and allow us to add key management hires as well as continue focusing on the development of our innovative micro-robotic technologies,” commented Harel Gadot, Chairman and Chief Executive Officer. “The products borne from these technologies will allow us to enhance the quality of life and address unmet medical needs impacting millions of patients globally.” Microbot Medical Inc. is a medical device company specializing in the design and development of transformational micro-robotic medical technologies. The Company is primarily focused on leveraging its micro-robotic technologies with the goal of allowing more physicians to treat more patients while improving surgical outcomes for the patients. The Company is currently developing its first two product candidates: the Self Cleaning Shunt, or SCS, for the treatment of hydrocephalus and Normal Pressure Hydrocephalus, or NPH; and TipCAT, a self-propelling, semi-disposable endoscope that is being developed initially for use in colonoscopy procedures. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. 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” and “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, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, 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 businesses of Microbot Medical Inc. particularly those mentioned in the cautionary statements found in Microbot Medical Inc.’s filings with the Securities and Exchange Commission. Microbot Medical disclaims any intent or obligation to update these forward-looking statements.
StemCells | Date: 2011-11-23
A substantially enriched mammalian hepatic liver engrafting cell population is provided. Methods are provided for the isolation and culture of this liver engrafting cell. The progenitor cells are obtained from a variety of sources, including fetal and adult tissues. The cells are useful in transplantation, for experimental evaluation, and as a source of lineage and cell specific products, including mRNA species useful in identifying genes specifically expressed in these cells, and as targets for the discovery of factors or molecules that can affect them.
News Article | February 3, 2015
Home remodeling shows are a reality TV staple. But no Park Avenue mansion or country estate can top the nearly $1 billion price tag of the house C. Randal Mills is trying to renovate on the fly in California. Mills, who goes by Randy, is the president of the State of California’s stem cell agency, which just turned 10 years old. A former biotech executive, he’s been on the job at CIRM for seven months, pushing what he calls “CIRM 2.0″: an overhaul to fulfill the agency’s unfinished business of bringing regenerative medicine therapies to patients. (CIRM stands for “California Institute for Regenerative Medicine.”) For some time, the agency has mulled ways to extend its life beyond the original $3 billion in bond money Californians voted for in 2004. Ideas of public-private partnerships, rich benefactors, or perhaps going back to the public have been floated. Turns out the answer, for now, is CIRM must first get its own house in order. The renovation plan could be fully in place by mid-year, if the agency’s board approves. Some of it Mills has discussed in detail, which we’ll delve into later, and some of it remains vague. With board meetings open and available online, it’s a reality show that skews more C-SPAN than Housewives. But it’s crucial for Californians of all stripes—taxpayers and patients, health providers and researchers alike—because CIRM has spent more than $2 billion on new buildings, job training, and R&D, yet only a handful of the projects it has funded have led to therapies now being tested in humans. That’s to be expected; turning radical new science into medical products is a long slog. But critics say CIRM’s original backers (real estate developer Bob Klein and the Proposition 71 campaign—one could call CIRM “The House That Klein Built”) underplayed that caveat to voting taxpayers a decade ago. Perhaps the media and public weren’t going to tune into it, anyway. But expectations are expectations. “CIRM-funded labs have produced genuine achievements,” wrote Los Angeles Times columnist Michael Hiltzik last summer. “But the specific cures promised by the Proposition 71 campaign haven’t materialized, which doesn’t surprise anyone steeped in the realities of the scientific method.” CIRM must also show it can fund industry without shooting itself in the foot. Awards to companies have been sparse, about 10 percent of the $2.1 billion total. One of the few firms to receive CIRM cash so far is StemCells Inc. of Newark, CA. CIRM awarded StemCells $19 million in 2012 to help with its experimental Alzheimer’s treatment, despite initial rejections from CIRM reviewers and a questionable tangle of close ties with folks like Stanford University researcher Irv Weissmann—a frequent recipient of CIRM grants and a StemCells founder and board member. The arrangement became an embarrassment in 2014 when Mills’s predecessor Alan Trounson, who oversaw the StemCells grant, immediately took a StemCells board seat upon leaving CIRM. In December, CIRM pulled the plug on its funding, but StemCells had already received nearly $10 million it won’t have to pay back. After Trounson’s ill-advised move—which reportedly took CIRM officials by surprise—the agency revised its conflict-of-interest policy, although it maintained that Trounson’s action broke no previous rules. It was the second big adjustment CIRM had made in three years. In late 2012, the U.S. Institute of Medicine, at CIRM’s behest, wrote a long report on the agency’s practices, pro and con, which spurred several changes, some related to conflict-of-interest problems and perceptions. Back in 2004, California voters said yes to $3 billion in bonds to fund the research agency, knowing that interest payments would swell the final bill to $6 billion. It was an expensive thumb-to-the-nose at President George W. Bush, whose executive rules—since overturned by President Obama—had cut off federal funding for nearly all embryonic stem cell research. California, the thought went, would skirt federal bans, build new buildings, attract bright minds, create new jobs, and ultimately share the financial and moral rewards of cures for all kinds of diseases. (Economic impact reports are notoriously squishy, but for what it’s worth, one commissioned by CIRM said in 2012 that from 2006 to 2014 the agency would generate 38,000 full time jobs and $205 million in state tax revenues.) But now it’s renovation time. Mills’s first task was to add a fresh coat of exterior paint, rebranding “CIRM 2.0″ as an efficient, business-friendly entity. According to the new rhetoric, CIRM is less a grant-making government agency than a “discerning investor” that’s going to be “as creative and innovative” as possible in getting treatments approved, Mills says. “We have no mission above accelerating stem cell therapies to patients.” That language is tuned to catch the ears of the biopharma industry, which CIRM needs to convince to take its money and move regenerative medicine products through the clinic. Mills ran Osiris Therapeutics (NASDAQ: OSIR), of Columbia, MD, for a decade and brought a stem-cell-based treatment to market for kids with graft-versus-host disease. He knows the language of business, as does chairman John Thomas, who cofounded a private equity firm in Santa Monica, CA. They are indeed promising big changes. The biggest, perhaps, is an overhaul of the grant application process, shaving it from as much as two years down to four months, and holding review meetings on the phone instead of flying reviewers to California and paying for hotel rooms. (Mills was one of those reviewers for five years.) Before, application windows would open every 12 to 18 months “like a game of whack-a-mole, and you had to apply whether or not you were ready,” says Mills. Now, scientists and companies can apply for grants at any time, and if their proposals aren’t up to snuff, they can amend them and resubmit them quickly. The first test of the new structure is already underway; the board has approved $50 million for clinical-stage projects, and there could be approvals by May. The rolling submissions will theoretically attract for-profit groups that previously didn’t want to get caught in the bureaucracy. “If we’re going to be in the drug development business, the continuum has to be predictable,” says Mills. Businesses will technically receive loans, not grants, but they will only pay CIRM back … Next Page »