NCT03762512RecruitingNot Applicable
Collection of Donated Placenta for Isolation of Mitochondria for Research and for Future Use in Mitochondrial Augmentation Therapies
Minovia Therapeutics Ltd.1 site in 1 country300 target enrollmentStarted: December 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Minovia Therapeutics Ltd.
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Placenta donated
Study Overview
Brief Summary
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Placenta donated
Time Frame: immediate
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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