Food and Drug Administration

Center for Biologics Evaluation and Research

Cellular, Tissue and Gene Therapies Advisory Committee

Meeting # 43


March 30, 2007

Hilton Hotel, Gaithersburg, Maryland




            Open Committee Discussion – Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies


8:00 a.m.                     Welcoming Remarks

                                                James Mulé, Ph.D., Chair

                                    Conflict of Interest Statement

                                                Gail Dapolito, Executive Secretary

                                    Introduction of Members

                                                James Mulé, Ph.D.


8:10                             FDA Introduction


8:30                             Pablo Rubinstein, M.D., Director

                                    New York Blood Center

                                    National Cord Blood Program

9:10                             Q&A


9:20                             FDA Presentation


10:00                           Q&A


10:10                          Break


10:30                           Open Public Hearing


11:30                           Lunch


12:30 p.m.                  Questions for Committee Discussion


3:00 p.m.                    Adjourn