Collection of Donated Placenta for Isolation of Mitochondria for Research and for Future Use in Mitochondrial Augmentation Therapies
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.
Eligibility Criteria
Inclusion Criteria: 1. Healthy pregnant females between the age of 18-45, judged to be medically eligible by the Investigator and the Sponsor's Medical Monitor. 2. Planned elective C-section at weeks 36-41 of pregnancy. 3. Uncomplicated pregnancy as determined by the Investigator. 4. Available Medical History of the donor (diagnosis, diseases, medication etc…) Exclusion Criteria: 1. 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. 2. Donor is at risk for a communicable disease as assessed by medical history, medical records, physical exam, and the Donor Screening Questionnaire. 3. Donor is at risk for COVID-19 as assessed by medical history, medical records, physical exam, and the COVID-19 Screening Questionnaire. 4. Donor smokes more than one pack of cigarettes a day or drinks more tha