Category Archives: FDA Stem Cell Trials

MADISON, WI--(Marketwire -02/22/12)- Novelos Therapeutics, Inc. (OTCQX: NVLT.OB - News) a pharmaceutical company developing novel drugs for treatment and diagnosis of cancer, today announced that the University of Wisconsin Carbone Cancer Center, a leading medical oncology research institution, has enrolled the first patient in a Phase 1-2 positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with advanced non-small cell lung cancer (NSCLC). Details of the trial design are available at http://www.clinicaltrials.gov ID: NCT00582283, or at http://www.novelos.com in the 'Clinical Trials' section. Anne M. Traynor, M.D., is the trial's principal investigator. "Surgical resection in properly selected NSCLC patients offers the best chance for long-term survival and may be curative. Consequently, accurate pre-operative assessment of local, regional and distant metastatic spread is critical for effective disease management," said Dr. Traynor. "If metastatic spread can be more accurately detected, we may be able to customize and optimize treatment decisions." "We are very pleased to be expanding our collaboration with the UW Carbone Cancer Center," said Harry Palmin, President and CEO of Novelos. "We look forward to obtaining initial LIGHT imaging data in the second quarter of 2012 in lung cancer patients. We believe positive data … Continue reading →

SAN BRUNO, Calif., Feb. 16, 2012 /PRNewswire/ -- Cord Blood Registry (CBR) is the exclusive partner for a growing number of clinical researchers focusing on the use of a child's own cord blood stem cells to help treat pediatric brain injury and acquired hearing loss. To ensure consistency in cord blood stem cell processing, storage and release for infusion, three separate trials have included CBR in their FDA-authorized protocol—including two at the University of Texas Health Science Center at Houston (UTHealth) working in partnership with Children's Memorial Hermann Hospital, and a third at Georgia Health Sciences University, home of the Medical College of Georgia (MCG). This makes CBR the only family stem cell bank pairing researchers with prospective patients for these studies.  (Logo: http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO) "Partnering with a series of specialists who want to research the use of a child's own newborn blood stem cells on a variety of disease states allows CBR to help advance medical research for regenerative therapies by connecting the child whose family banked with CBR to appropriate researchers," said Heather Brown, MS, CGC, Vice President of Scientific & Medical Affairs at Cord Blood Registry.  "The pediatric specialists from UTHealth, Children's Memorial Hermann Hospital, and Georgia Health Sciences … Continue reading →

Stem cells are proving themselves beneficial once again after scientists used the controversial building blocks to resurrect dead, scarred heart muscle damaged by recent heart attack. Results from a Cedars-Sinai Heart Institute clinical trial show that treating heart attack patients with an infusion of their own heart-derived cells helps damaged hearts re-grow healthy heart muscle. Reporting in The Lancet medical journal, the researchers said this is the clearest evidence yet that broken hearts can heal. All that is needed is a little help from one’s own heart stem cells. “We have been trying as doctors for centuries to find a treatment that actually reverses heart injury,” Eduardo Marban, MD, PhD, and lead author of the study, told WebMD. “That is what we seem to have been able to achieve in this small number of patients. If so, this could change the nature of medicine. We could go to the root of disease and cure it instead of just work around it.” Marban invented the “cardiosphere” culture technique used to create the stem cells and founded the company developing the treatment. “These findings suggest that this therapeutic approach is feasible and has the potential to provide a treatment strategy for cardiac … Continue reading →

Featured Article Academic Journal Main Category: Stem Cell Research Also Included In: Cardiovascular / Cardiology Article Date: 14 Feb 2012 - 2:00 PST email to a friend   printer friendly   opinions   Current Article Ratings: Patient / Public: 5 (1 votes) Healthcare Prof: Details of a small clinical trial published in The Lancet on Tuesday reveal how scientists helped patients with hearts damaged by heart attack to re-grow healthy heart muscle and reduce scar tissue with an infusion of stem cells taken from the patients' own hearts. Leading international cardiologist and heart researcher Dr Eduardo Marbán, who is director of the Cedars-Sinai Heart Institute in Los Angeles and Mark S. Siegel Family Professor, is senior author of the study. He told the press what they saw in the trial: "... challenges the conventional wisdom that, once established, scar is permanent and that, once lost, healthy heart muscle cannot be restored." In 2009, Marbán and his team had already shown it is possible, following a heart attack, to grow specialized stem cells from the patient's own heart tissue (called cardiosphere-derived cells or CDCs), inject them back into the patient's damaged heart, and see they reduce scars, increase muscle and boost … Continue reading →

ROCKVILLE, Md., Feb. 14, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced today that it has closed on its previously announced registered direct placement of 5,200,000 shares of common stock at a price of $1.00 per share, and 5,200,000 warrants each with an exercise price of $1.02 per share and exercisable starting six months from the issuance date for a term of five years. The company received aggregate gross proceeds of $5,200,000, which will be used for general corporate purposes, including ongoing U.S. clinical trials. (Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO ) T.R. Winston & Company, LLC acted as the exclusive placement agent for the offering. About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA. In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, … Continue reading →

SUNRISE, Fla., Feb. 14, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has acquired the worldwide exclusive rights to Ageless Regenerative Institute's adipose (fat) derived therapeutic cell technology for use in the cardiac field. "The Ageless adipose stem cell technology will allow us to broaden our portfolio of product candidates for cardiac patients," said Mike Tomas, President and CEO of Bioheart. "We have successfully treated patients in Mexico and now we are ready to expand into the US." Adipose tissue is readily available and has been shown to be rich in microvascular, myogenic and angiogenic cells. Bioheart has recently applied to the FDA to begin trials using adipose derived stem cells or LipiCell(TM) in patients with chronic ischemic cardiomyopathy. Transplantation of LipiCell(TM) will be accomplished through endocardial implantations with the MyoStar(TM) Injection Catheter under the guidance of the NOGA(R) cardiac navigation system by Biosense Webster, Inc. -- A Johnson & Johnson Company. Under the terms of the agreement, Bioheart will have a worldwide exclusive license to all of Ageless technology for use in the heart attack and heart failure markets. The agreement provides for upfront and milestone equity payments to Ageless. Ageless' President and Chief Executive Officer, … Continue reading →

02-02-2012 11:09 Good Morning, It's Thursday February 2nd, 2012, I'm Christina Collins with CRWENewswire Stocks In Action StemCells Incorporated - symbol STEM - reported that the FDA has authorized the initiation of a Phase I/II clinical trial of the Company's proprietary HuCNS-SC product candidate (purified human neural stem cells) in dry age-related macular degeneration On its first quarter fiscal 2012, Green Mountain Coffee Roasters Incorporated - symbol GMCR - posted GAAP operating income of $145.8 million, compared to $23.3 million in the same period the prior year and lastly; Discovery Laboratories Incorporated - symbol DSCO - reported that AFECTAIR is now registered with the FDA and is cleared to be marketed in the United States. AFECTAIR is a proprietary patient interface technology that simplifies delivery of aerosolized medications to patients requiring ventilator support. Thank you for joining me andhave a great day! For CRWE Newswire, Stocks In Action, I'm Christina Collins ********************************* THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY! Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. crwenewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers.Our disclaimer (Read … Continue reading →

01-02-2012 14:02 Incorporated in 2005, Stemedica has become a global biopharmaceutical company led by prominent scientists, leading clinicians, experienced investors and seasoned medical, biotechnology and pharmaceutical executives. Our mission is to develop and manufacture best-in-class ischemic-tolerant allogeneic stem cells that support pre-clinical and clinical studies conducted by approved research institutions and accredited hospitals. Stemedica's stem cell manufacturing capacity is among the largest in the world. We operate a US FDA-compliant cGMP (Current Good Manufacturing Practices) facility in San Diego, California that is licensed by the Food and Drug Branch of the State of California Department of Health and Human Services. We also have manufacturing facilities and master banks that advance our technology in Lausanne, Switzerland and Seoul, Korea. In addition to our manufacturing capabilities, we are also involved in pre-clinical and clinical trials in which our products are at the forefront of medical advances. This includes our own FDA approved Phase I/II clinical trial for Ischemic Stroke. http://www.Stemedica.com Read more from the original source: Stemedica Cell Technologies - Documentary - Video … Continue reading →

NEWARK, Calif., Feb. 2, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced that the U.S. Food and Drug Administration (FDA) has authorized the initiation of a Phase I/II clinical trial of the Company's proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD), the most common form of AMD. AMD is the leading cause of vision loss and blindness in people over 55 years of age, and approximately 30 million people worldwide are afflicted with the disease. There are no approved treatments for dry AMD. "With the approval of this trial, we have accomplished something truly unique in the stem cell field, which is the extension of clinical testing of our proprietary human neural stem cell platform to all three elements of the central nervous system: the brain, spinal cord and eye," said Martin McGlynn, President and CEO of StemCells, Inc. "The preclinical data supporting our IND is particularly compelling and we look forward to getting this trial underway." The Phase I/II trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The trial will be an open-label, dose-escalation study, and is expected to enroll … Continue reading →

Newswise — In the quest to find treatments for certain neurological diseases, BrainStorm is fast distinguishing itself as a leader in the field of regenerative medicine using stem cells through its unique platform called NurOwn. The Company can process human mesenchymal stem cells, which are present in bone marrow and are capable of self-renewal as well as differentiation into many other tissues. What makes BrainStorm technology platform very attractive to Big Pharma partnering is the autologous nature of the bone marrow-derived stem cells. This will in turn drastically reduce the expected translation time to market. The value of a treatment for ALS in the U.S. and EU is estimated to be $4Billion. The potential applications for the NurOwn platform to treat disease is fast becoming a reality. In short, BrainStorm is leveraging a patients own cells to heal itself of disease. BrainStorm updated stakeholders recently with a review of the trial six months post transplantation. The Phase I/II clinical trial for ALS is being conducted at the prestigious Hadassah Medical Center in Jerusalem by renowned Professor Dimitrios Karussis, M.D., Ph.D. and a distinguished scientific team in its own right from BrainStorm headed by Professor Eldad Melamed. Patients have been transplanted … Continue reading →