Pregnancy RelatedNCT03762512
Collection of Donated Placenta for Isolation of Mitochondria for Research and for Future Use in Mitochondrial Augmentation Therapies
An observational study of Pregnancy Related, run by Minovia Therapeutics Ltd. at 1 site in Israel.
Trial summary
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2018to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant females giving term birth by C-section
Who may be able to join
- 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…)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center Hospital- Tel Hashomer
Ramat Gan
Diana Chigalayev, 972-3-5307145, diana.chigalayev@sheba.gov.il
Elad Jacobi, MD, 972-3-5303037, elad.jacoby@sheba.gov.il
About this study
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.
- Conditions
- Pregnancy Related
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Dec 2018
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minovia Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762512
- Sponsor's protocol ID
- MNV-005
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2018
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Donated Placenta for Isolation of Mitochondria for Research and for Future Use in Mitochondrial Augmentation Therapies
- ClinicalTrials.gov ID
- NCT03762512
- Acronym / sponsor ID
- MNV-005
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Minovia Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant females giving term birth by C-section
Key inclusion criteria (4 listed)
- 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…)
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Minovia Therapeutics Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klari Uziel (+972544817280, klariuz@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placenta donated (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.