Status:
RECRUITING
Collection of Donated Placenta for Isolation of Mitochondria for Research and for Future Use in Mitochondrial Augmentation Therapies
Lead Sponsor:
Minovia Therapeutics Ltd.
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-45 years
Brief Summary
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03762512
Start Date
December 1 2018
End Date
March 1 2028
Last Update
June 22 2025
Active Locations (1)
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1
Sheba Medical Center Hospital- Tel Hashomer
Ramat Gan, Israel