FDA Panel to Review Oocyte Modification Therapy

The FDA Cellular, Tissue, and Gene Therapies Advisory Committee will be meeting this week to discuss potential clinical trials of mitochondrial manipulation to treat female infertility and to prevent transmission of mitochondrial disease from mother to fetus.

In mitochondrial manipulation, the nuclear DNA (nDNA) from a healthy donor egg or embryo is removed and the nDNA from the mother is added. Because these diseases are inherited via mitochondrial DNA (mtDNA), the fetus would inherit traits from the mother and father but not the mitochondrial disease. Over 300 pathogenic mtDNA mutations have been identified and there are currently no FDA-approved treatments.

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A 2002 FDA Advisory Committee ruled against recommending infertility treatment using ooplasm transfer due to insufficient data on safety concerns relating to potential accidental chromosome transfer and increasing the survival of certain embryos with significant birth defects. Due to new technologies and scientific data, the Committee will be re-evaluating the safety and efficacy for potential clinical trials.

For more information, visit the FDA Advisory Committee website.