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

NCT03762512 | Recruiting

• 1 other identifier: MNV-005
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Placenta donated

  The purpose of this study is to collect placenta for the production of mitochondria. Therefore, only general measurements are taken such as placenta weight and health of mother during pregnancy. No further intervention or interaction with the mother will occur, and she does not receive any drug product or treatment prior to or after placenta donation.

  immediate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Must be pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant females giving term birth by C-section

You may qualify if:

• 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…)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minovia Therapeutics Ltd.: lead

Study Sites (1)

Sheba Medical Center Hospital- Tel Hashomer

Ramat Gan, Israel

RECRUITING

Central Study Contacts

Klari Uziel

CONTACT

+972544817280; klariuz@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: December 1, 2018
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)