Food and Drug
Administration
Center for
Biologics Evaluation and Research
Cellular, Tissue
and Gene Therapies Advisory Committee
March 4, 2005
Meeting #38
Quality Suites,
Rockville, MD
DRAFT AGENDA
March
4, 2005
Open
Committee Discussion
Topic I
- Cellular Therapies for Repair and Regeneration of Joint Surfaces
8:00 a.m. Welcome and Administrative Remarks
8:05 Committee
Discussion of Clinical Questions
8:30 FDA Perspective on Development of Cartilage Repair Products – Manufacturing
8:50 Committee Discussion of Manufacturing Questions
11:00 Lunch
Topic II – Update on Retroviral Vector-Mediated Insertional Tumorigenesis
12:00 noon Open Public Hearing
12:30 p.m. FDA Introduction
Guest Presentations:
12:45 Update on Severe Adverse Event in X-SCID Gene Therapy Protocol
1:25 Report on a Myeloid Malignancy Arising in a Rhesus Macaque 6 Years Following Transplantation of Retrovirally-Transduced Cells
2:00 Update on Murine Studies with Wildtype Murine Retroviruses
2:30 Retroviral Vector-Mediated Insertional Mutagenesis: Insights from Mouse Models
2:45 Use of Retroviral Vector-Mediated Gene Transfer in ADA-SCID Clinical Trials
3:10 Committee Discussion of Questions
5:00 p.m. Adjourn