Donation of placenta to collect mitochondria for future mitochondrial augmentation therapies

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

This project collects placentas donated by healthy women having elective C-section deliveries so mitochondria can be harvested for possible future mitochondrial augmentation therapies.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Minovia Therapeutics Ltd. (Industry-sponsored)
• Locations: 1 site (Ramat Gan)
• Trial ID: NCT03762512 on ClinicalTrials.gov

What this trial studies

The program enrolls healthy pregnant women aged 18–45 who plan an elective C-section between 36 and 41 weeks and who have uncomplicated pregnancies. Donated placentas are screened for infectious risks and relevant medical history before collection. Mitochondria are isolated from collected placentas and stored for research and potential future therapeutic use. There is no intervention to the donor beyond consent and standard delivery care.

Who should consider this trial

Good fit: Ideal candidates are healthy pregnant women aged 18–45 planning an elective C-section at 36–41 weeks with an uncomplicated pregnancy and available medical history.

Not a fit: Women who are positive or at risk for communicable diseases, have complicated pregnancies, heavy tobacco or alcohol use, or who do not plan an elective C-section are unlikely to qualify or benefit from participation.

Why it matters

Potential benefit: If successful, the collected mitochondria could support development of mitochondrial augmentation therapies that may help people with mitochondrial disorders.

How similar studies have performed: Related approaches to mitochondrial isolation and augmentation have shown promise in preclinical work and very early human studies, but broad clinical benefit remains unproven.

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.

Where this trial is running

Ramat Gan

• Sheba Medical Center Hospital- Tel Hashomer — Ramat Gan, Israel (Recruiting)

Study contacts

• Study coordinator: Klari Uziel

Conditions Pregnancy Related