LOS ANGELES – Oct. 21, 2010 – A team of physicians and scientists from the Cedars-Sinai Regenerative Medicine Institute and Department of Surgery, led by Dan Gazit, DMD, PhD has been awarded a three-year $1.9 million grant from the California stem cell agency to fund research leading to clinical trials for what could become the first biological treatment for the most common type of bone fracture in osteoporosis patients.
The grant was announced Thursday by the California Institute of Regenerative Medicine as one of 19 Early Translation II Awards aimed at developing a new stem cell therapy for an unmet medical need or clearing up a bottleneck in the development of new therapies.
"Vertebral fractures are a common, painful problem for adults with osteoporosis and it can cause severe back pain and disabilities," said Gazit. "Currently, there are not many effective options for treatment so our goal is to develop a biological treatment that not only promotes healing but also stimulates normal bone production."
Vertebral compression fractures account for approximately 700,000 injuries in the United States each year – twice as many as hip fractures. They often are a result of a severe jolt to the spine, or a weakening of the spine due to osteoporosis. Approximately 10 million Americans are diagnosed with osteoporosis, a condition that primarily affects older women and is characterized by decrease in bone mass that causes bone brittleness. Another 34 million Americans have low bone mass, which also increases vulnerability to vertebral compression fractures.
Medical therapy and research have focused mainly on prevention, but when compression fractures occur, the only medical interventions available involve injection of synthetic, non-biological material that does not absorb into tissues and remains a permanent foreign body fixture in the spine.
The grant will be used to conduct studies in which animals with osteoporosis and vertebral fractures are treated with intravenous injections of human adult stem cells and a hormone already approved by the FDA for the treatment of osteoporosis patients. The study is scheduled to begin in early 2011.
"We are excited about Dr. Gazit's research and grateful for the ongoing support from the California Institute for Regenerative Medicine," said Clive Svendsen, Ph.D. director of the Cedars-Sinai Regenerative Medicine Institute. "This grant will allow us to continue advancing the use of adult stem cells to the next level, which is towards clinical use in order to give renewed hope for a healthier quality of life to the millions diagnosed with osteoporosis and related disorders."
Bruce Gewertz, MD, chair of the Department of Surgery and vice-president for interventional services said, "in the future, innovative application of stem cells will likely be an invaluable tool for surgeons to foster healing in a wide range of musculo-skeletal injuries."
The California Institute for Regenerative Medicine was established in November, 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act, which provided $3 billion in funding for stem cell research at universities and research institutions.
The Cedars-Sinai Regenerative Medicine Institute brings together basic scientists with specialist clinicians, physician scientists and translational scientists across multiple medical specialties to translate fundamental stem cell studies to therapeutic regenerative medicine. The Institute is housed in new laboratories designed for stem cell and regenerative medicine research. At the heart of the Institute is a specialized core facility for the production of pluripotent stem cells capable of making all tissues in the human body from adult human skin biopsies. Cells produced within the Institute are for use in a variety of Cedars-Sinai medical research programs, currently focusing on understanding the causes of and finding treatments for diseases of the brain, heart, eye, liver, kidney, pancreas and skeletal structures, as well as cancer and metabolic disorders.
Under Svendsen's direction, the Cedars-Sinai Regenerative Medicine Institute has been gaining notice. Recently, the institute received a $3.7 million National Institutes of Health grant to provide five leading laboratories, including one at Cedars-Sinai, with the adult stem cells to be used in the development of potential therapies to address another fatal neurodegenerative condition, Huntington's disease, and another CIRM grant aimed at understanding more about stem cell transplant rejection.