NeoStem has been awarded a two-year grant totaling $1,221,854 for "Repair of Bone Defects with Human Autologous Pluripotent Very Small Embryonic-Like Stem Cells (VSEL)" from the National Institute of Dental and Craniofacial Research (NIDCR), a division of the National Institutes of Health (NIH). This peer-reviewed grant is to support a Phase II investigation and first-approved NIH clinical study of VSELs™ in humans. The study will be headed by Denis O. Rodgerson, Ph.D., director of grants and academic liaison for NeoStem, in collaboration with co-investigators Russell Taichman, D.M.D., D.M.Sc., and Laurie McCauley, D.D.S., Ph.D., of the University of Michigan. Enrollment for this study is expected to begin in 2013.
This award will fund the evaluation of VSEL stem cells as a potential treatment for periodontitis. The product candidate, a therapy derived from a patient's own stem cells, is to be developed for use in the regeneration of bone tissue damaged by this disease. The award includes $706,682 for the first year and $515,172 for the second year of the project, and will cover the cost of the Investigational New Drug (IND) submission to the FDA for the product candidate.
NeoStem has a worldwide exclusive license to VSEL technology, which uses very small embryonic-like stem cells, a heterogeneous population of stem cells found in adult bone marrow that have properties similar to those of embryonic stem cells. According to NeoStem, very small embryonic-like stem cells can be mobilized into the peripheral blood, enabling a minimally invasive means for collecting what it believes to be an important population of stem cells that may have the potential to achieve the positive benefits associated with embryonic stem cells without the ethical or moral dilemmas or the potential negative biological effects associated with them.
Robin L. Smith, M.D., chairman and CEO of NeoStem, added, "We are very excited about this important step of funding for what will be the first human clinical study for our VSEL technology. Not only will this study expand our knowledge of how autologous cell therapy can treat periodontitis and other bone defects, but it represents a milestone for NeoStem as we move our development of VSEL technology beyond animal models and into the clinic, paving the way for other potential VSEL trials."
In June of this year, NeoStem won a two-year, $595,252 research grant from NIAID to fund evaluation and development of VSELs as a potential countermeasure against radiation exposure resulting from nuclear accident or terrorism.