May 2005 Armand M. Karow, Ph.D. Xytex Corporation Augusta, GA Women at Risk of Cytotoxic Sterility: Federal Involvement in Reproductive Tissue Preservation

Xytex Corporation Cytotoxic therapy: Chemotherapy Radiation therapy Curative but also reproductive sterility Cancer Bone marrow transplants Autoimmune diseases Xytex Corporation

Talking points : Avoiding reproductive sterilization Avoiding federal involvement in clinical practice Xytex Corporation

Follicle Cells Injured by Cytotoxic Rx Oocytes Granulosa Thecal cells Xytex Corporation

Consequences (50%) Premature ovarian failure Premature menopause Sterility Xytex Corporation

Consequences: Fertility (40%) With: Early pregnancy loss Premature labor Low birth-weight infant Xytex Corporation

Protecting Female Reproductive Capacity Physical Shield Pharmacological Shield Xytex Corporation

Isolation and Storage of Female Germinal Material Tissue Cryopreservation Xytex Corporation

Embryo Cryopreservation 40% pregnancy rate Isolation and Storage of Female Germinal Material Xytex Corporation

Oocyte Cryopreservation < 3% pregnancy rate Isolation and Storage of Female Germinal Material Xytex Corporation

Ovarian Tissue Cryopreservation New Option Being Tried in Humans Isolation and Storage of Female Germinal Material Xytex Corporation

21 CFR Part 1271 Human Cellular and Tissue Based Products 25 May 2005 Xytex Corporation

21 CFR Part 1271 Regulates the Processor Not the Tissue Not the Process Xytex Corporation

21 CFR Subparts A.General Provisions B.Procedures for Registration and Listing C.Donor Eligibility D.Current Good Tissue Practices E.Additional Requirements F.Inspection and Enforcement Xytex Corporation

21 CFR 1271 Processors of Autologous Tissues A.General Provisions B.Procedures for Registration and Listing C. D.Current Good Tissue Practices E.Additional Requirements F.Inspection and Enforcement Xytex Corporation

21 CFR 1271 Processors of Autologous Reproductive Tissues A.General Provisions B.Procedures for Registration and Listing C. D. E. F.Inspection and Enforcement Xytex Corporation

You are regulated by 21 CFR 1271 if: You minimally manipulate tissues. (IVF programs DO these activities) Xytex Corporation

You are NOT regulated by 21 CFR 1271 if: You receive transplantable tissues from a regulated entity. Xytex Corporation

Copy of 21 CFR 1271 from Xytex Corporation