women at risk of cytotoxic sterility: federal involvement in reproductive tissue preservation
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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May 2005
Armand M. Karow, Ph.D.Xytex Corporation
Augusta, GA
Women at Risk ofCytotoxic Sterility:
Federal Involvement in Reproductive Tissue
Preservation
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Xytex Corporation
Cytotoxic therapy:
• Chemotherapy• Radiation therapy
Curative but also reproductive sterility• Cancer• Bone marrow transplants• Autoimmune diseases
Xytex Corporation
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Xytex Corporation
Talking points:
• Avoiding reproductive sterilization• Avoiding federal involvement in
clinical practice
Xytex Corporation
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Xytex Corporation
Follicle Cells
Injured by Cytotoxic Rx
• Oocytes• Granulosa• Thecal cells
Xytex Corporation
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Xytex Corporation
Consequences (50%)
Premature ovarian failure
Premature menopause
Sterility
Xytex Corporation
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Xytex Corporation
Consequences: Fertility (40%)
With:Early pregnancy loss
Premature labor
Low birth-weight infant
Xytex Corporation
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Xytex Corporation
Protecting FemaleReproductive Capacity
Physical Shield
Pharmacological Shield
Xytex Corporation
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Xytex Corporation
Isolation and Storage of Female Germinal Material
Tissue Cryopreservation
Xytex Corporation
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Xytex Corporation
Embryo Cryopreservation40% pregnancy rate
Isolation and Storage of Female Germinal Material
Xytex Corporation
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Xytex Corporation
Oocyte Cryopreservation< 3% pregnancy rate
Isolation and Storage of Female Germinal Material
Xytex Corporation
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Xytex Corporation
Ovarian Tissue Cryopreservation
New Option Being Tried in Humans
Isolation and Storage of Female Germinal Material
Xytex Corporation
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21 CFR Part 1271Human Cellular and
Tissue Based Products25 May 2005
Xytex Corporation
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21 CFR Part 1271Regulates the Processor
Not the Tissue
Not the Process
Xytex Corporation
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Xytex Corporation
21 CFR 1271- Subparts
A. General ProvisionsB. Procedures for Registration and
ListingC. Donor EligibilityD. Current Good Tissue PracticesE. Additional RequirementsF. Inspection and Enforcement
Xytex Corporation
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Xytex Corporation
21 CFR 1271Processors of Autologous
TissuesA. General ProvisionsB. Procedures for Registration and
ListingC.D. Current Good Tissue PracticesE. Additional RequirementsF. Inspection and Enforcement
Xytex Corporation
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Xytex Corporation
21 CFR 1271Processors of Autologous
Reproductive Tissues
A. General ProvisionsB. Procedures for Registration and
ListingC.D.E.F. Inspection and Enforcement
Xytex Corporation
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You are regulated by21 CFR 1271 if:
You minimallymanipulate tissues.
(IVF programs DO these activities)
Xytex Corporation
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Xytex Corporation
You are NOT regulated by21 CFR 1271 if:
You receive transplantable tissues from a regulated
entity.
Xytex Corporation
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Xytex Corporation
Copy of 21 CFR 1271 from
www.xytex.com
Xytex Corporation