Category Archives: Stem Cell Human Trials

Jan. 9, 2013 Apparent stem cell transplant success in mice may hold promise for people with amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease. The results of the study were released today and will be presented at the American Academy of Neurology's 65th Annual Meeting in San Diego, March 16 to 23, 2013. "There have been remarkable strides in stem cell transplantation when it comes to other diseases, such as cancer and heart failure," said study author Stefania Corti, MD, PhD, with the University of Milan in Italy and a member of the American Academy of Neurology. "ALS is a fatal, progressive, degenerative disease that currently has no cure. Stem cell transplants may represent a promising avenue for effective cell-based treatment for ALS and other neurodegenerative diseases." For the study, mice with an animal model of ALS were injected with human neural stem cells taken from human induced pluripotent stem cells (iPSCs). iPSC are adult cells such as skin cells that have been genetically reprogrammed to an embryonic stem cell-like state. Neurons are a basic building block of the nervous system, which is affected by ALS. After injection, the stem cells migrated to the spinal cord of the mice, matured … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC or the Company), a leader in the field of regenerative medicine, announced today that investigators for the Companys Phase I/II clinical trials for Stargardts macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD) have observed evidence of engraftment of the transplanted human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells and visual acuity gain in patients treated over the 18 months since the trials were first initiated. The Company believes this observation of engraftment and persistence is clinically important because engraftment of cells in the proper area, and recapitulation of normal RPE cell layer structure is important to the ultimate efficacy of the RPE cells in the treatments. Additionally, investigators have not observed any issues of safety relating to the transplanted human embryonic stem cell (hESC)-derived RPE cells in any of the 18 patients treated. The company believes this warrants early (though cautious) optimism as the company looks forward to initiating the second half of the three trials. Now that we are at the halfway point in all three of our ongoing trials, we have had the opportunity to stop and assess not only the data relating to … Continue reading →

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)-- BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the Israeli Ministry of Health has fast-tracked its current Phase I/II ALS safety trial to a Phase IIa dose-escalating trial, significantly expediting the companys clinical development program and saving valuable time. The trial, which will evaluate the safety and preliminary efficacy of BrainStorms NurOwn stem cell therapy candidate, will be launched immediately at the Hadassah Medical Center in Jerusalem. The Ministry of Health approved acceleration to a Phase IIa trial based on evaluation of only 12 of the initial cohort of 24 patients in the companys Phase I/II trial at Hadassah. In the Phase IIa trial, the second group of 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. The study participants, who have already been recruited, will be followed for three to six months after transplantation. Acceleration to Phase IIa will save us critical time, enabling us to proceed much more quickly with achieving our goal of developing an effective treatment for ALS, commented Dr. Adrian Harel, BrainStorms CEO. Professor Dimitrios Karussis, Principal Investigator of … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) and its recently formed subsidiary BioTime Acquisition Corporation (BAC) jointly announced today that they have entered into a definitive Asset Contribution Agreement with Geron Corporation (GERN) to acquire the intellectual property, including patents and patent applications, and other assets related to Gerons human embryonic stem (hES) cell programs consistent with the financial terms outlined in the letter of intent announced on November 15, 2012. Under the definitive agreement, Geron will contribute to BAC intellectual property, certain cell lines and other assets, including the Phase 1 clinical trial of hES cell-derived oligodendrocytes in patients with acute spinal cord injury, and Gerons autologous cellular immunotherapy program. BioTime will contribute to BAC $5 million in cash, 8,902,077 BioTime common shares to be held by BAC, five-year warrants to purchase 8,000,000 common shares of BioTime at a price of $5.00 per share (BioTime Warrants), rights to use certain clinical grade hES cell lines, a sublicense to use certain patents for stem cell differentiation technology, and minority stakes in two of BioTimes subsidiaries, OrthoCyte Corporation and Cell Cure Neurosciences Ltd. BAC will also pay to Geron royalties on the sale of products that are commercialized, if any, … Continue reading →

Jan. 3, 2013 When a young athlete dies unexpectedly on the basketball court or the football field, it's both shocking and tragic. Now Stanford University School of Medicine researchers have, for the first time, identified the molecular basis for a condition called hypertrophic cardiomyopathy that is the most common cause for this type of sudden cardiac death. To do so, the Stanford scientists created induced pluripotent stem cells, or iPS cells, from the skin cells of 10 members of a family with a genetic mutation that causes the condition. The researchers then coaxed the cells to become heart muscle cells so they could closely study the cells' behavior and responsiveness to the chemical and electrical signals that keep a heart beating normally. They also used these bioengineered heart cells to quickly pinpoint the drugs most likely to be effective in human patients and to study their potential as preventive medications. "For obvious reasons, it's difficult to get primary human heart tissue from living patients for study," said cardiologist and stem cell researcher Joseph Wu, MD, PhD. "Moreover, animal hearts are not ideal substitutes either because they contract differently and have a different composition than human hearts. As a result, it … Continue reading →

Public release date: 3-Jan-2013 [ | E-mail | Share ] Contact: Krista Conger kristac@stanford.edu 650-725-5371 Stanford University Medical Center STANFORD, Calif. When a young athlete dies unexpectedly on the basketball court or the football field, it's both shocking and tragic. Now Stanford University School of Medicine researchers have, for the first time, identified the molecular basis for a condition called hypertrophic cardiomyopathy that is the most common cause for this type of sudden cardiac death. To do so, the Stanford scientists created induced pluripotent stem cells, or iPS cells, from the skin cells of 10 members of a family with a genetic mutation that causes the condition. The researchers then coaxed the cells to become heart muscle cells so they could closely study the cells' behavior and responsiveness to the chemical and electrical signals that keep a heart beating normally. They also used these bioengineered heart cells to quickly pinpoint the drugs most likely to be effective in human patients and to study their potential as preventive medications. "For obvious reasons, it's difficult to get primary human heart tissue from living patients for study," said cardiologist and stem cell researcher Joseph Wu, MD, PhD. "Moreover, animal hearts are not ideal … Continue reading →

Researchers have already safely injected stem cells into patients with neurodegenerative diseases and spinal cord injuries -- and they've seen the potential to vastly improve lives. Knut Olstad in August 2011, 20 minutes before the accident that left him paralyzed below the waist Marcus Hilton has probably been going blind since he was born, though he didn't really begin to notice that something was wrong until he was seven or eight. Several years after that, he was officially diagnosed with Stargardt disease, the leading cause of juvenile blindness. Thirty-four years of decline later, his retinas irreparably damaged, he is unable to drive, read fine print, or recognize people from a distance. For Knut Olstad, devastation came much more suddenly. Having quit smoking and taken up cross-country skiing and bicycling in an early mid-life crisis, he was 45 years old and on what he described as the vacation of his life, conquering 25 mountains on the Tour de France route. On the last descent of the twenty-fifth mountain, on what might even have been the final turn of the entire trip, a car veered into his lane. He swerved out of the way, squeezed just a little too hard on the … Continue reading →

Mesenchymal (MSC) stem cells send out homing signals that recruit other stem cells and mobilize them to heal wounds, researchers at the Chicago Medical School at Rosalind Franklin University of Medicine and Science have discovered. MSC stem cells are better suited to initiating the healing process rather than repairing tissue damage themselves, the researchers explain in an article published today in Stem Cells Translational Medicine. Durham, NC (PRWEB) December 21, 2012 Scientists Daniel Peterson and Laura Shin used MSC cells extracted from human bone marrow and grafted them into wounds of healthy mice and mice with diabetes. Mice in both groups each had two separate wounds to better allow the researchers to study the precise role the cells played in healing. Some mice in each group received MSC cells in one wound while others did not receive the cells at all. After studying the differences in healing, signaling and cell populations in the mice, Peterson and Shin learned that both normal and impaired mice given MSC cells healed more quickly, even in wounds that did not receive direct MSC cell grafts. The mice that received MSC cells demonstrated a systemic response, Peterson said. This suggests that the key to repairing … Continue reading →

Stemedica Cell Technologies, Inc., a leading manufacturer of adult ischemia tolerant allogeneic stem cells and stem cell factors announced that the Company has signed an agreement with The Scripps Research Institute to investigate the role of Stemedicas ischemia tolerant human mesenchymal stem cells and stem cell factors as a therapy for severe lung injury and sepsis. San Diego, CA (PRWEB) December 21, 2012 Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) are the most common causes of respiratory failure among critically ill patients. The mortality for this syndrome remains high at 30-40% and accounts for approximately 75,000 deaths per year. Severe bacterial pneumonia is the most common cause of ALI/ARDS and is frequently associated with septic shock. The only intervention for ALI/ARDS that has resulted in a mortality benefit is low tidal volume ventilation. Despite several attempts, there have been no pharmacological agents that have reduced the morbidity or mortality from ALI/ARDS. Furthermore, treatment of bacterial pneumonia is increasingly hampered by the rapid spread of multi-drug resistant bacteria and the lack of new antimicrobial agents to treat them. Therefore, given the large public health impact of severe bacterial pneumonia and ALI/ARDS, novel therapies are needed to address this … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC or the Company), a leader in the field of regenerative medicine, today announced that its iPS cell-derived human platelet program has been named as one of the 10 Ideas That Will Shape The Year in the Christmas and New Year Special issue of the New Scientist, widely considered to be one of the most influential science and technology news magazines in the world. The list includes innovations in different scientific areas such as health and medicine, climate change, technology and others. ACTs platelet program aims to provide a renewable, donorless source of blood platelets to people in need of platelet transfusions. Human iPS cells are a game-changer in medicine, said Robert Lanza, M.D., chief scientific officer of ACT. They offer the possibility to generate a non-controversial, unlimited source of patient-specific stem cells without embryo destruction. Owing to their short storage time, there is a constant demand for this life-saving blood component. Since platelets dont contain any genetic material, they cannot form tumors, which makes them ideal for the first clinical trial involving the iPS cell technology. We hope to initiate the first clinical trial using these promising cells in 2013. … Continue reading →