ES cell biopsy from blastocyst.
Filed under: Advanced Cell Technology, Athersys, Clinical Trials, Cytori, Embyonic Stem Cells, FDA, Geron, JNJ, Novocell, Osiris, Regenerative Medicine, adult stem cell, spinal cord injury, stem cells | Tagged: Clinical Trials, embryonic vs adult stem cell, embyryonic stem cell 2008, evolving clinical landscape, safety issues | Leave a Comment »
The FDA has scheduled an April 10, 2008 meeting to “discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells.” This meeting will be followed by another meeting on April 11 that will “discuss updates on 1) research management related to the September 29, 2005 review of research programs [...]
Filed under: Advanced Cell Technology, Clinical Trials, Embyonic Stem Cells, FDA, Geron, Novocell, Regenerative Medicine, cell delivery, regulatory, stem cells | 1 Comment »
On November 15, 2007, Athersys announced in a press release that they had received a letter from the FDA giving the green light to start a Phase I safety study of MultiStem, their adult, allogeneic stem cell product. Athersys will start an open label, dose escalation trial to test their cells after bone marrow transplantation.
This [...]
Filed under: Athersys, Clinical Trials, FDA, MSCs, Osiris, Regenerative Medicine, adult stem cell, stem cells | Tagged: adult stem cells, Athersys, business model, stem cells clinical trials | 1 Comment »
