Collection of Donated Placenta for Isolation of Mitochondria for Research and for Future Use in Mitochondrial Augmentation Therapies

Inclusion criteria

• Healthy pregnant females between the age of 18-45, judged to be medically eligible by the Investigator and the Sponsor's Medical Monitor.
• Planned elective C-section at weeks 36-41 of pregnancy.
• Uncomplicated pregnancy as determined by the Investigator.
• Available Medical History of the donor (diagnosis, diseases, medication etc…)

Exclusion criteria

• Donor is positive for a communicable disease, such as: HBV, HCV, HIV 1&2, WNV, HTLV 1&2, Treponema pallidum, CMV, Chagas, Chlamydia Trachomatis, Neisseria Gonorrhea, or any other tests required by the medical facility, IMoH, FDA, EMA or the Sponsor.
• Donor is at risk for a communicable disease as assessed by medical history, medical records, physical exam, and the Donor Screening Questionnaire.
• Donor is at risk for COVID-19 as assessed by medical history, medical records, physical exam, and the COVID-19 Screening Questionnaire.
• Donor smokes more than one pack of cigarettes a day or drinks more than one alcoholic beverage a day.
• Donor has taken a medication with potential mitochondrial effects within 2 weeks prior to placental donation, such as valproic acid, aminoglycoside antibiotics, neuromuscular blocking drugs (See Appendix 3).
• Donor has current or history of malignancy.
• Donor has current or history of insulin dependent diabetes
• Donor has current gestational diabetes treated with insulin, or pre-eclampsia.
• Donor is known to be a carrier of a primary mitochondrial disease.