Category Archives: FDA Stem Cell Trials

Dennis Douda (@ddouda) published a blog post January 17th, 2014 Mayo Clinic Discovery Leads to FDA Approval for Stem Cell Trial for Heart Failure Patients U.S. FDA Approves Phase III Cardiopoietic Stem Cell Trial for Heart Failure Patients Based on a Mayo Discovery Cardio3 BioSciences, an international Mayo Clinic collaborator, has received FDA approval for a phase III pivotal clinical trial of its stem cell therapy.The trial will test the Mayo Clinic discovery of cardiopoietic (cardiogenically-instructed) stem cells designed to improve heart health in people suffering from heart failure.The multisite U.S. trial, called CHART-2, will aim to recruit 240 patients with chronic advanced symptomatic heart failure. Cardio3 BioSciences is a bioscience company in Mont-Saint-Guibert, Belgium. "Regenerative medicine is poised to transformthe way we treat patients," says Andre Terzic, M.D., Ph.D., director of the Mayo Clinic Center for Regenerative Medicine. Watch the video below to see how stem cells are being used to treat people with heart failure. Journalists: Video b-roll of today's news conference, plussound bites with Dr. Terzic and Christian Homsy, M.D., CEO of Cardio3 BioSciences, areavailable in the downloads. The video pkg. is also available in the downloads in MOV format. Cardio3 Biosciencescardiopoetic Dr. Andre Terzic Dr Terzic … Continue reading →

Cloning Fears Resurface The stem cell advances have reawakened fears they will be used toward human reproductive cloning. In 1998, FDA declared jurisdiction over clinical trials intended to study the practice, citing authority over INDs. But as Bernard Siegel, J.D., executive director of the Genetics Policy Institute, correctly noted to GEN, the agency didnt use its notice-and-comment rulemaking or official guidance processes. Instead, FDAs then-acting commissioner Michael A. Friedman, M.D., simply said so in a radio interview. The FDA needs to take the matter seriously and reiterate its authority. The agency should make sure its authority will not be undermined for its casualness in establishing its original claims of jurisdiction, Siegel said. Last year, Siegel and Arnold I. Friede, J.D., whose eponymous law firm specializes in FDA matters, co-authored a Stem Cells and Development article urging FDA to formally establish jurisdiction over cloning, with input from all stakeholders. The Center for Genetics and Society wants Washington to go further, urging Congress to join some U.S. states and 60 countries in banning reproductive cloning. Marcy Darnovsky, Ph.D., the centers executive director, cited efforts by several scientists a decade ago to clone humans, and the cost of creating stem cell lines. The … Continue reading →

I've very rarely used Wheelchair Kamikaze to directly appeal for charitable donations to help any individual research project, as I've always been extremely wary of abusing the trust that's been built up between me and my readers. Very recently, though, I've been alerted to a cause that I feel is so fundamentally worthwhile that I decided to devote this entire essay to making such an appeal. One of the most cherished dreams of every patient suffering from the ravages of multiple sclerosis is to see their losses reversed, to one day triumphantly trash their canes, walkers, and wheelchairs; to at long last find eyesight restored, withered limbs strengthened, and numbed minds sharpened. For those whose lives have been victimized by MS, this is the stuff of reverie, a hope so precious that it can sometimes feel taboo to speak of for fear it may be crushed. It is the power of such dreams that make the use of stem cells to treat multiple sclerosis one of the most tantalizing areas of study currently underway in the world of MS research. Stem cell therapy offers the hope of repairing damaged tissues in the central nervous system, thereby restoring function lost to … Continue reading →

MIAMI (PRWEB) June 04, 2014 GlobalStemCellsGroup.com, its subsidiary Stem Cell Training, Inc. and Bioheart, Inc. have announced a new 16 CME online credit course for physicians. Working at their own pace from the privacy of home or office, physicians can learn how to implement regenerative medicine techniques in their own practices. Taught by stem cell and regenerative medicine expert Kristin Comella, the online course provides didactic lectures on regenerative medicine and scientifically validated protocols. Lecture topics include: Included in the online coursework are training videos, training booklets, detailed protocols and power point presentations with instructions and images for: Medical professionals can also choose to combine the online coursework with one-on-one training with a regenerative medicine specialist. For more information, visit the Global Stem Cells website,, email bnovas(at)regenestem(dot)com, or call 305-224-1858. About the Global Stem Cells 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 … Continue reading →

The treatment of advanced melanoma has changed dramatically in the last few years, but there continues to be a need to increase the number of patients who experience a long-term survival benefit, said Dr. Mario Sznol, Yale University School of Medicine and Yale Cancer Center, presenter of the results. While these are Phase 1b data, the duration of response and one- and two-year survival rates observed with the combination regimen of nivolumab and Yervoy are very encouraging and support the rationale for the ongoing, late stage trials of this combination regimen. The science of immuno-oncology harnessing the patients immune system to treat cancer is rapidly evolving, said Michael Giordano, senior vice president, Head of Development, Oncology & Immunology at Bristol-Myers Squibb. These results are the most advanced data set to date evaluating the potential of combining immune checkpoint inhibitors. As leaders in the field, they reinforce our aspiration that combining immunotherapies may be foundational and may have the potential to change the standard of care by transforming survival expectations. Results from Phase 1b Combination Regimen (Study -004) Study 004 is a dose-ranging Phase 1 study (n=127) evaluating the safety, antitumor activity and pharmacokinetics of the combination regimen of nivolumab and … Continue reading →

PHOENIX--(BUSINESS WIRE)--Creative Medical Health, Inc. (CMH) announced today initiation of efforts to recruit a preeminent U.S. urologist as principal investigator to run a Phase I/II study under FDA jurisdiction assessing efficacy of its patented method of treating erectile dysfunction. Creative Medical Health, Inc. owns U.S. patent #8,372,797, titled Treatment of Erectile Dysfunction by Stem Cell Therapy, which covers the use of various stem cells for treatment of patients who are resistant to Viagra, Cialis and Levitra. In contrast to pharmaceutical agents, the treatment developed by Creative Medical Health, Inc. involves regenerating the blood vessels and smooth muscle of the penis, thus offering the possibility of permanent regeneration, not a temporary remedy. The medical procedure involves extracting stem cells from the patients own bone marrow, processing them and subsequent administration into the penis. A peer-reviewed study describing the first patient treated with this procedure may be found at http://www.translational-medicine.com/content/pdf/1479-5876-11-139.pdf. There are approximately 18 million patients with erectile dysfunction in the USA. Of these, 30% are resistant to pharmaceutical interventions, which represents approximately 5.4 million potential patients that could benefit from our approach, stated Timothy Warbington, CEO of Creative Medical Health, Inc. Given that this patient group has limited alternatives besides costly … Continue reading →

Shares of Geron Corporation ( GERN ) were down 6.09% after the company reported first quarter 2014 results. Geron posted a net loss of 6 cents per share in the first quarter of 2014, in line with the Zacks Consensus Estimate but narrower than the year-ago loss of 9 cents. First quarter revenues of $474,000 were below the year-ago revenues of $765,000 and the Zacks Consensus Estimate of $1 million. A significant decline in expenses led to the narrower loss. Quarter in Detail Revenues consisted entirely of royalties and license fees. Total operating expenses declined 27.8% to $9.2 million. Research and development expenses declined 34.9% to $5.2 million due to reduced personnel-related costs as well as lower costs resulting from the winding-down of the imetelstat (metastatic breast cancer and advanced non-small cell lung cancer) and GRN1005 (brain metastases) studies. This was partially offset by higher costs related to the manufacturing of imetelstat. Meanwhile, general and administrative expenses declined 15.9% to $4 million mainly due to lower patent costs and transaction expenses associated with the Oct 2013 closing of the stem cell divestiture. R&D expenses will remain consistent through the rest of the year unless the full clinical hold on imetelstat … Continue reading →

You may have heard about stem cells and research on using them to repair, replace, or regenerate damaged cells, tissues, or organs. A few days ago the U.S. Food and Drug Administration reported the latest progress, especially intriguing to those of us with worn-out joints not to mention brains. New brains: anyone interested? But seriously, this is about the possibility of personalized medicine tailored to your individual needs. So heres the update: First, a definition: Stem cells are basic mother cells that can develop into every cell, tissue, and organ in the body. A large team of FDA scientists is studying how adult not embryonic stem cells could repair, replace, restore, or regenerate cells damaged by injury, illness, or normal wear, including those needed for heart and bone repair. Its not science fiction, Steven Bauer, chief of the FDAs cellular and tissue therapy branch, said. Mature cells can differentiate mature into several cell types, such as bone, fat, cartilage, and nerve cells, he said. Those cells have been used for repairing hearts, bone, and cartilage. But growing stem cells and ensuring theyre safe and effective is tough, Bauer said, which is why clinical trials have not yet resulted in a … Continue reading →

Neuralstem Logo. (PRNewsFoto/NEURALSTEM, INC.) ROCKVILLE, Md., April 16, 2014 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that the Institutional Review Board of the University of California, San Diego, School of Medicine has approved the Phase I safety trial to treat chronic spinal cord injury (cSCI) with its NSI-566 stem cells. The NSI-566/cSCI Phase I trial will enroll patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association (AIS) A level of impairment,between one and two years after injury. AIS A impairment, which is complete paralysis, refers to a patient with no motor or sensory function in the relevant segments at and below the injury. The trial, which already has FDA approval, and has a one-year completion goal, will be under the direction of principal investigator (PI) Joseph Ciacci, MD, UC San Diego School of Medicine and neurosurgeon at UC San Diego Health System. Much of the pre-clinical work with the NSI-566 cells in spinal cord injury was conducted at UC San Diego School of Medicine by Martin Marsala, MD, professor in the Department of Anesthesiology, who will be another study investigator. "Moving our spinal cord cells into human trials for a second indication in the … Continue reading →

Stem cells are cells that have the ability to divide and develop into many different cell types in the body during early life and growth. Stem cells may also help repair the body by dividing to replenish cells that are damaged by disease, injury, or normal wear. When a stem cell divides, each new cell has the potential either to remain a stem cell or to become another type of cell with a more specialized function, such as a nerve cell, a skin cell, or a red blood cell. Three types of stem cells have been identified: 1. adult stem cells 2. human embryonic stem cells 3. induced pluripotent stem cells These three types of stem cells share properties: Adult stem cells can be found throughout the body. They are found as unspecialized cells among the specialized cells in tissues and organs as well as in umbilical cord blood and peripheral blood (that is, hematopoietic stem cells). An adult stem cell can either divide to make more adult stem cells, or differentiate to produce some or all of the major specialized cell types of the tissue or organ. Human embryonic stem cells (hESC) come from embryos that develop from eggs … Continue reading →