This study will be conducted in three phases. The first phase is a feasibility study that will entail entering a minimum total of 13 patients at all of the participating centers to assess the 'feasibility of completing the protocol as well as the safety issues involved. It will be an uncontrolled trial. The data from this study will be submitted to the NIH for the second phase, which would be a fully funded, randomized, prospective,
controlled-blinded trial. Should this second phase show positive results, it may stand alone or necessitate the third phase, a much larger multicenter trial.