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

Launched by MINOVIA THERAPEUTICS LTD. · Nov 30, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a special part of the placenta called mitochondria, which are tiny structures that provide energy to our cells. The goal is to collect these mitochondria from healthy pregnant women who are having a planned C-section. The researchers want to use the harvested mitochondria for a treatment known as mitochondrial augmentation therapy, which may help improve health in certain conditions.

To be eligible for this trial, women must be healthy and having a single baby (not twins or more), with a straightforward pregnancy. They should be planning to have an elective C-section. However, women who have certain health issues, such as being carriers of mitochondrial diseases or having high levels of smoking or drinking, cannot participate. If eligible, participants can expect to provide placenta samples during their procedure, contributing to important research that could benefit future patients.

Gender

FEMALE

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 than one alcoholic beverage a day.
• • 5. 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).
• • 6. Donor has current or history of malignancy.
• • 7. Donor has current or history of insulin dependent diabetes
• • 8. Donor has current gestational diabetes treated with insulin, or pre-eclampsia.
• • 9. Donor is known to be a carrier of a primary mitochondrial disease.