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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
Xytex Corporation
Cytotoxic therapy:
• Chemotherapy• Radiation therapy
Curative but also reproductive sterility• Cancer• Bone marrow transplants• Autoimmune diseases
Xytex Corporation
Xytex Corporation
Talking points:
• Avoiding reproductive sterilization• Avoiding federal involvement in
clinical practice
Xytex Corporation
Xytex Corporation
Follicle Cells
Injured by Cytotoxic Rx
• Oocytes• Granulosa• Thecal cells
Xytex Corporation
Xytex Corporation
Consequences (50%)
Premature ovarian failure
Premature menopause
Sterility
Xytex Corporation
Xytex Corporation
Consequences: Fertility (40%)
With:Early pregnancy loss
Premature labor
Low birth-weight infant
Xytex Corporation
Xytex Corporation
Protecting FemaleReproductive Capacity
Physical Shield
Pharmacological Shield
Xytex Corporation
Xytex Corporation
Isolation and Storage of Female Germinal Material
Tissue Cryopreservation
Xytex Corporation
Xytex Corporation
Embryo Cryopreservation40% pregnancy rate
Isolation and Storage of Female Germinal Material
Xytex Corporation
Xytex Corporation
Oocyte Cryopreservation< 3% pregnancy rate
Isolation and Storage of Female Germinal Material
Xytex Corporation
Xytex Corporation
Ovarian Tissue Cryopreservation
New Option Being Tried in Humans
Isolation and Storage of Female Germinal Material
Xytex Corporation
21 CFR Part 1271Human Cellular and
Tissue Based Products25 May 2005
Xytex Corporation
21 CFR Part 1271Regulates the Processor
Not the Tissue
Not the Process
Xytex Corporation
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
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
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
You are regulated by21 CFR 1271 if:
You minimallymanipulate tissues.
(IVF programs DO these activities)
Xytex Corporation
Xytex Corporation
You are NOT regulated by21 CFR 1271 if:
You receive transplantable tissues from a regulated
entity.
Xytex Corporation
Xytex Corporation
Copy of 21 CFR 1271 from
www.xytex.com
Xytex Corporation