Category Archives: FDA

The Developing Embyronic Stem Cell Clinical Landscape

Posted on February 14, 2008 by jrowley

ES cell biopsy from blastocyst. Continue reading →

Posted in adult stem cell, Advanced Cell Technology, Athersys, Clinical Trials, Cytori, Embyonic Stem Cells, FDA, Geron, JNJ, Novocell, Osiris, Regenerative Medicine, spinal cord injury, stem cells | Tagged , , , , | Leave a comment

FDA Proactively Addresses Embryonic Stem Cell Safety Testing

Posted on December 31, 2007 by jrowley

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 … Continue reading →

Posted in Advanced Cell Technology, cell delivery, Clinical Trials, Embyonic Stem Cells, FDA, Geron, Novocell, Regenerative Medicine, regulatory, stem cells | 1 Comment

Athersys’ adult allogeneic stem cell IND gets OK from FDA

Posted on November 20, 2007 by jrowley

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 … Continue reading →

Posted in adult stem cell, Athersys, Clinical Trials, FDA, MSCs, Osiris, Regenerative Medicine, stem cells | Tagged , , , | 1 Comment