www.fdanews.com/articles/88690-pharma-blog-watch
Pharma Blog Watch
November 9, 2006
Firm
to Study Cord-Blood Stem Cells (Pharma Gazette)
In her blog, Gloria Gamat reports that Gamida Cell "has reached an agreement
under a Special Protocol Assessment (SPA) with the USFDA regarding the design
of the global, pivotal, historical controlled, registration study of StemEx
for the treatment of hematological malignancies."
"Composed of ex-vivo expanded cord blood stem/progenitor cells, which are transplanted in combination with non-expanded cells from the same cord blood unit, StemEx may provide an alternative source of stem cells for these patients by enabling the use of cord blood for transplantation," she explains.