Aastrom submits SPA for Phase 3 clinical development system in critical limb ischemia to FDA Aastrom Biosciences, Inc. , a respected developer of extended autologous cellular treatments for the treatment of severe cardiovascular diseases, today announced that it offers submitted to the U.S. Food and Medication Administration a particular protocol evaluation describing the company’s proposed Phase 3 medical development program in essential limb ischemia . If the FDA concurs with the protocols outlined in the SPA, Aastrom expects to initiate the Phase 3 system in early 2011. ‘We are very happy to have reached this essential milestone for our CLI plan and our programs for the Phase 3 pivotal clinical program stick to track,’ said Tim Mayleben, cEO and president of Aastrom.No other severe or recurrent infections were reported, no long-term anti-infectious treatments were reported. The individuals had no problems after routine vaccinations, including live viral vaccines. Individual 1 provides attended a special education plan since kindergarten and has therefore presumably been subjected to infectious diseases; Patient 2 is homeschooled owing to a far more severe neurologic phenotype. Both individuals were evaluated through the National Institutes of Health Undiagnosed Disease Program and the NIH Primary Immune Deficiency Clinic. Based on the genetic and biochemical results, the siblings received a diagnosis of CDG-IIb Expression and Immunoglobulin Studies in Two Siblings with Congenital Disorder of Glycosylation Type IIb ., and Section S1 in the Supplementary Appendix, available with the full text of this content at NEJM.org).