IRVINE, Calif. California Stem Cell, Inc. (CSC) announced today that the U.S. Food and Drug Administration (FDA) has approved the Companys application to begin a Phase III clinical trial exploring the potential of a cancer stem cell-based platform therapy to treat advanced metastatic melanoma. The protocol has received Special Protocol Assessment (SPA), indicating that FDA is in agreement that the design, clinical endpoints, and planned clinical analyses of the Phase III trial address regulatory objectives sufficient for market approval. The therapy has also been granted fast track status by FDA, a designation given to therapies which show promise in treating life-threatening medical conditions, which accelerates the approval of investigational new drugs undergoing clinical trials. The study, to be led by Robert Dillman, M.D., F.A.C.P., medical oncologist at the Hoag Family Cancer Institute of Hoag Memorial Hospital Presbyterian, calls for enrolling 250 patients with recurrent Stage III or Stage IV metastatic melanoma in a multi-centered, randomized, double-blind study that compares overall survival of patients who receive CSCs patient-specific cancer immunotherapy, known as DC-TC, against patients receiving a control treatment. CSC's "DC-TC" therapy begins with cancer stem cells that have been isolated from a patient's resected tumor sample, enriched and inactivated. This … Continue reading →

Oct 22, 2013 What can we expect from the first U.S. human clinical trials of stem cell therapy for spinal cord injury (SCI)? In an exciting development, StemCells, Inc., has announced that it has received FDA authorization to begin clinical trials of its Investigational New Drug (IND) application of purified stem cell therapy to treat chronic spinal cord injury. This means that the breakthrough therapy for stem cell injuries can now begin testing on human patients in the United States. The company, which focuses on the research and development of therapies and tools for use in stem-cell-based research, began trials about a year ago in Switzerland and Canada, and sees the potential breakthrough therapy currently being tested on a total of seven patients in those countries. The company calls the therapy HuCNS-SC, which stands for human neural stem cells. Research for the therapy has been ongoing since 2002, when pre-clinical studies conducted with researchers at the University of California, Irvine showed that human neural stem cells engraft long-term, migrate to the area of injury, and transform themselves into specialized cells that create the protein myelin, a vital substance in treating spinal cord injury. The research eventually showed that transplantation of … Continue reading →

Wednesday's Child This Kid With A Big Heart Hopes To Find Forever Family This Kid With A Big Heart Hopes To Find Forever Family Born in 2000, Timothy is a kid with many interests and a big heart. He's all about sports, especially baseball, and is a Dodgers fan. Born in 2000, Timothy is a kid with many interests and a big heart. He's all about sports, especially baseball, and is a Dodgers fan. Updated: Monday, December 2 2013 12:19 PM EST2013-12-02 17:19:50 GMT This week in Gina's People it's all about music. Our FOX 11 viewer, Jack Ramsey goes out of his way to help patients at Torrance Memorial Medical Center feel like they are at a concert hall. This week in Gina's People it's all about music. Our FOX 11 viewer, Jack Ramsey goes out of his way to help patients at Torrance Memorial Medical Center feel like they are at a concert hall. Updated: Friday, November 29 2013 12:30 AM EST2013-11-29 05:30:54 GMT GOING GREEN: The Chevy Spark EV is a much more entertaining driver than the standard gasoline model, largely due to the huge electric torque on tap. GOING GREEN: This years LA Auto Show is … Continue reading →

The Tisch MS Research Center of New York has received IND approval from the FDA to commence a phase I trial using autologous neural stem cells in the treatment of multiple sclerosis (MS). MS is a chronic human autoimmune disease of the central nervous system that leads to myelin damage and neurodegeneration and affects approximately 2.1 million people worldwide. "To my knowledge, this is the first FDA-approved stem cell trial in the U.S. to investigate direct injection of stem cells into the cerebrospinal fluid of MS patients, and represents an exciting advance in MS research and treatment," said Dr. Saud A. Sadiq, senior research scientist at Tisch MS Research Center of New York and the study's Principal Investigator. The study will investigate a regenerative strategy using stem cells harvested from the patient's own bone marrow.These stem cells will be injected intrathecally (into the cerebrospinal fluid surrounding the spinal cord) in 20 participants who meet the inclusion criteria for the trial. This will be an open label safety and tolerability study.All study activities will be conducted at the Tisch MS Research Center and affiliated International Multiple Sclerosis Management Practice (IMSMP). The clinical application of autologous neural progenitors in MS is the … Continue reading →