Approximately 10 million people in the United States are diagnosed as osteoporotic, while an additional 34 million are classified as having low bone mass. The lifetime incidence of fragility fractures secondary to osteoporosis in females over the age of fifty years of age is approximately 1 in 2, and in males over the age of fifty, is 1 in 4. Vertebral compression fractures (VCFs) are the most common fragility fractures in the United States, accounting for approximately 700,000 injuries per year, twice the rate of hip fractures. Approximately 70,000 VCFs result in hospitalization each year with an average hospital stay per patient of 8 days. There are limited options of treatment when VCFs occur. New, non-biological, methods have been developed to regain the biomechanical properties of a fractured vertebral body. These methods include the minimally invasive procedures of vertebroplasty and balloon tamp reduction. Both procedures involve injection of synthetic nonbiological material that does not resorb and instead remains a permanent foreign-body fixture in the spine. Ultimately, a biological solution that would promote rapid fracture healing and stimulate normal bone production would be the best for osteoporotic patients with vertebral column injuries. Our goal is to develop a novel therapy for VCFs, which will be based on adult stem cells, isolated from bone marrow samples. These cells will be “triggered” to form bone by the activation of a specific gene and then injected into the fractured vertebra leading to fast fracture repair. The funding from the planning award allowed us to establish a highly experienced team, from the academy and industry, that would be able to bring the proposed therapy to clinical use. In addition, we assembled a comprehensive development plan that described in detail the studies and steps required to obtain an approval from the FDA in order to begin clinical trials. Furthermore, we have negotiated and obtained commitment from several biotech companies, which will provide the necessary materials and facilities to perform the studies described in the development plan. Our proposal for a Disease Team Therapy Development Award was submitted in January 2012. If awarded, we will be beginning the pre – clinical studies in August 2012.