Category Archives: Stem Cell Human Trials

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the first patient in the third dosage cohort, and seventh patient overall, in its European Phase I clinical trial for Stargardts macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was injected with 150,000 hESC-derived RPE cells, as compared with the 100,000-cell dose used in patients of the second cohort. The surgery was performed on Friday, April 19, without any complications, and the patient is recovering uneventfully. Europe represents a huge potential market for us, the worlds largest after the U.S., so we are particularly pleased to now be past the halfway point in all three of our clinical trials on both continents, commented Gary Rabin, chairman and CEO of ACT. SMD affects as many as 100,000 patients in the U.S. and Europe. Moreover, as previously announced, the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) officially granted our hESC-derived RPE cells orphan medicinal product designation for the treatment of SMD. We expect this will provide a number of benefits once our SMD treatment has made the … Continue reading →

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that Professors Arshed Quyyumi, MD, FRCP, FACC and Javed Butler, MD, MPH, FACC, FAHA of the Emory Clinical Cardiovascular Research Institute have agreed to join the Scientific Advisory Board for Stemedicas Cardiology Division. San Diego, CA (PRWEB) April 22, 2013 Dr. Arshed A. Quyyumi has been involved in clinical translational research in cardiovascular diseases for over 25 years. His research focuses on vascular biology, angiogenesis, progenitor cell biology, mechanisms of myocardial ischemia, and the role of genetic and environmental risks on vascular disease. In 2001 he was appointed Professor of Medicine in the Division of Cardiology at the Emory University School of Medicine. In 2010, he was named Co-Director of the Emory Clinical Cardiovascular Research Institute (ECCRI). Dr. Quyyumi serves on the editorial boards of several national journals and is a reviewer for the National Institute of Healths (NIH) National Heart, Lung and Blood Institute Study Sections. Dr. Quyyumi has authored more than 220 peer-reviewed publications and has been an invited speaker and session chair at many scientific meetings and conferences. During his academic career, Dr. Quyyumi has managed more than 50 NIH, … Continue reading →

Apr. 22, 2013 Understanding exactly how stem cells form into specific organs and tissues is the holy grail of regenerative medicine. Now a UC Santa Barbara researcher has added to that body of knowledge by determining how stem cells produce different types of "daughter" cells in Drosophila (fruit flies). T he findings appear today in the Proceedings of the National Academy of Sciences. Denise Montell, Duggan Professor of Molecular, Cellular and Developmental Biology at UCSB, and colleagues studied the ovaries of fruit flies in order to see stem cells in their natural environment. Because these organisms are excellent models for understanding stem cell biology, researchers were able to shed light on the earliest stages of follicle cell differentiation, a previously poorly understood area of developmental biology. "It is clear that the fundamental principles that control cell behavior in simple animals are conserved and control the behavior of our cells as well," she said. "There is so much we can learn by studying simple organisms." Using a nuclear protein expressed in follicle stem cells (FSCs), the researchers found that castor, which plays an important role in specifying which types of brain cells are produced during embryonic development, also helps maintain FSCs … Continue reading →

NEWARK, Calif., April 18, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced the addition of the Byers Eye Institute at Stanford, located in Palo Alto, Calif., as a second site for the Company's Phase I/II clinical trial of its proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) in dry age-related macular degeneration (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. Approximately 90 percent of AMD patients have the dry form of the disease and there are no approved treatments for dry AMD. The Byers Eye Institute at Stanford, which is part of Stanford Hospital & Clinics, is dedicated to combating blindness and preserving sight. The Institute leverages the research and teaching strengths of Stanford and integrates all vision care services at Stanford into one state-of-the-art facility. Theodore Leng, MD, FACS, clinical assistant professor in ophthalmology at the Stanford University School of Medicine, is the lead investigator at the site. Stanford's Department of Ophthalmology is a nationally acclaimed leader for treatment of retinal diseases, refractive disorders, neuro-ophthalmic disorders and diseases of the vitrea. "We are excited to be … Continue reading →

Controlling the differentiation of human pluripotent stem cells is the goal of many laboratories, both to study normal human development and to generate cells for transplantation in treating various diseases and conditions. In a study published in STEM CELLS Translational Medicine, a team of researchers found a way to isolate RPE (retinal pigmented epithelial) cells, a cell type that protects and nourishes the photoreceptors and is vital in maintaining healthy eyesight, as early as 14 days following the onset of differentiation. Durham, NC (PRWEB) April 18, 2013 In fact, the dysfunction and death of RPE is thought to be behind the leading cause of blindness in the Western world age related macular degeneration. Transplantation of RPE cells into the retina to treat AMD has been demonstrated in animals and is now being tested in clinical trials in humans. However, protocols to generate RPE from human pluripotent stem cells are time consuming and relatively inefficient. But a team of scientists at the University of California, Santa Barbara, reports in the latest issue of STEM CELLS Translational Medicine that it has found a way to isolate RPE cells as early as 14 days following the onset of differentiation. "RPE cells are required … Continue reading →

Public release date: 18-Apr-2013 [ | E-mail | Share ] Contact: B. D. Colen bd_colen@harvard.edu 617-413-1224 Harvard University Cambridge, MA, April 18, 2013 - Using a new stem-cell based drug screening technology with the potential to reinvent and greatly reduce the cost of the way new pharmaceuticals are developed, Harvard Stem Cell Institute (HSCI) researchers have found a compound more effective in protecting the neurons killed in amyotrophic lateral sclerosis (ALS) Lou Gehrig's disease than two drugs that failed in human clinical trials after hundreds of millions of dollars had been invested in them. The new stem cell screening technique developed by Lee Rubin, a member of HSCI's Executive Committee and a professor in Harvard's Department of Stem Cell and Regenerative Biology, successfully predicted that the two drugs that eventually failed in the third and final stage of human testing would, in fact, fail. "It's a deep, dark secret of drug discovery that very few drugs have been tested on human-diseased cells before being tested in a live person," said Rubin, who heads HSCI's program in translational medicine. "We were interested in the notion that we can use stem cells to correct that situation." Rubin's model is built on an … Continue reading →

Apr. 18, 2013 Using a new, stem cell-based, drug-screening technology that could reinvent and greatly reduce the cost of developing pharmaceuticals, researchers at the Harvard Stem Cell Institute (HSCI) have found a compound that is more effective in protecting the neurons killed in amyotrophic lateral sclerosis (ALS) than are two drugs that failed in human clinical trials after large sums were invested in them. The new screening technique developed by Lee Rubin, a member of HSCI's executive committee and a professor in Harvard's Department of Stem Cell and Regenerative Biology (SCRB), had predicted that the two drugs that eventually failed in the third and final stage of human testing would do just that. "It's a deep, dark secret of drug discovery that very few drugs have been tested on human-diseased cells before being tested in a live person," said Rubin, who heads HSCI's program in translational medicine. "We were interested in the notion that we can use stem cells to correct that situation." Rubin's model is built on an earlier proof of concept developed by HSCI principal faculty member Kevin Eggan, who demonstrated that it was possible to move a neuron-based disease into a laboratory dish using stem cells carrying … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the first patient in patient cohort 2a, consisting of patients with better vision, in its U.S. clinical trial for Stargardts Macular Dystrophy (SMD), a form of juvenile macular degeneration. The surgery was performed on Thursday, April 11 atWills Eye Institutein Philadelphia, by JosephMaguire, M.D., aco-investigator on the trial. The protocol is overseen by Principle Investigator,Carl D. Regillo, M.D.,Chief of the Wills Eye Institute Retina Service, and professor of ophthalmology at Thomas Jefferson University. The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. As the company announced on Jan. 22, patients with a visual acuity of 20/100 are eligible for enrollment in cohort 2a in the two U.S. clinical trials, for SMD and dry age-related macular degeneration (dry AMD). By treating patients earlier in the course of the disease, the Company believes that the amended patient protocol may have a more significant impact on photoreceptor rescue and visual function. In previous protocols, only SMD patients with a visual acuity no better than hand movement in the treated eyes and dry AMD patients with … Continue reading →

Scientists have developed a new, simpler way to produce human pluripotent stem cells in quantities large enough that they can be used to develop treatments for age-related macular degeneration the leading cause of irreversible blindness among the elderly. The results of this new study are published in the current issue of STEM CELLS Translational Medicine. Durham, NC (PRWEB) April 12, 2013 Age-related macular degeneration (AMD), which affects up to 50 million people worldwide, is associated with the dysfunction and death of retinal pigment epithelial (RPE) cells. As a result, there has been significant interest in developing RPE culture systems both to study AMD disease mechanisms and to provide substrate for possible cell-based therapies. Because of their indefinite self-renewal, human pluripotent stem cells (hPSCs) have the potential to provide an unlimited supply of RPE-like cells, noted Donald Zack, M.D., Ph.D., who with Julien Maruotti, Ph.D., led the team of researchers from the Wilmer Institute, Johns Hopkins University School of Medicine in Baltimore, Md., and the Institute of Vision in Paris in conducting the study. However, most of the currently accepted methods in use for deriving RPE cells from hPSC involve time-and-labor-consuming steps done by hand, and they dont yield large enough … Continue reading →

NEWARK, Calif., April 11, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that it has entered into an agreement with the California Institute for Regenerative Medicine (CIRM) under which CIRM will provide approximately $19.3 million to help fund preclinical development and IND-enabling activities of the Company's proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) for Alzheimer's disease. The funding, which will be in the form of a forgivable loan, was awarded under CIRM's Disease Team Therapy Development Award program (RFA 10-05) in September 2012. The goal of the research will be to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration within four years. "With CIRM's support, we are now able to lay the groundwork that could result in the world's first neural stem cell trial in Alzheimer's patients," commented Martin McGlynn, President and CEO of StemCells, Inc. "Currently, there are no good treatment options for Alzheimer's patients, and there aren't any on the horizon, so it is clear that the field could benefit from creative approaches to this devastating and challenging disease. Our collaborators at UC Irvine have provided a compelling preclinical rationale to test the utility of our cells to restore … Continue reading →