Donation of placenta to collect mitochondria for future mitochondrial augmentation therapies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Klari Uziel
• Email: klariuz@clalit.org.il
• Phone: +972544817280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.