Life Technologies Corporation (Nasdaq: LIFE) announced it has received FDA 510(k) clearance for StemPro® MSC SFM a first for this next-generation stem cell culture medium that is now cleared as a medical device and satisfies a crucial requirement for researchers involved in clinical trials in the United States…”
An FDA-cleared, serum-free medium certainly provides a positive step toward moving away from mostly animal-based products for growing mesenchymal stem cells,” said Stanton L. Gerson, MD, Professor, Division of Hematology Oncology in the Department of Medicine, Director, University Hospitals Seidman Cancer Center and the National Center for Regenerative Medicine, at Case Western Reserve University, a pioneer in the use of adult stem cells to treat cancer and heart disease who is also part of a team conducting early phase clinical trials with MSCs to treat graft-versus-host disease and multiple sclerosis. “Growth media that is better defined can facilitate regulatory requirements. Ultimately, clinical trials will determine whether it benefits patients.”
