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Women at Risk of Cytotoxic Sterility: Federal Involvement in Reproductive Tissue Preservation

Women at Risk of Cytotoxic Sterility: Federal Involvement in Reproductive Tissue Preservation. Armand M. Karow, Ph.D. Xytex Corporation Augusta, GA. May 2005. Cytotoxic therapy:. Chemotherapy Radiation therapy Curative but also reproductive sterility Cancer Bone marrow transplants

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Women at Risk of Cytotoxic Sterility: Federal Involvement in Reproductive Tissue Preservation

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

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

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

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

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

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

  7. Protecting FemaleReproductive Capacity Physical Shield Pharmacological Shield Xytex Corporation Xytex Corporation

  8. Isolation and Storage of Female Germinal Material Tissue Cryopreservation Xytex Corporation Xytex Corporation

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

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

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

  12. 21 CFR Part 1271Human Cellular andTissue Based Products25 May 2005 Xytex Corporation

  13. 21 CFR Part 1271Regulates the ProcessorNot the TissueNot the Process Xytex Corporation

  14. 21 CFR 1271- 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 Xytex Corporation

  15. 21 CFR 1271Processors 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 Xytex Corporation

  16. 21 CFR 1271Processors of Autologous Reproductive Tissues A. General Provisions B. Procedures for Registration and Listing C. D. E. F. Inspection and Enforcement Xytex Corporation Xytex Corporation

  17. You are regulated by21 CFR 1271 if:You minimallymanipulate tissues.(IVF programs DO these activities) Xytex Corporation

  18. You are NOT regulated by21 CFR 1271 if:You receive transplantable tissues from a regulated entity. Xytex Corporation Xytex Corporation

  19. Copy of 21 CFR 1271 fromwww.xytex.com Xytex Corporation Xytex Corporation

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