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NCT03762512 Clinical Trial

Collection of Placenta for Mitochondria Isolation

Pregnancy Related Clinical Trial

Official title:
Collection of Placenta for Mitochondria Isolation for Use in Mitochondrial Augmentation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03762512
Other study ID # MNV-PLC-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date December 2024

Study information
Verified date February 2020
Source Minovia Therapeutics Ltd.
Contact Diana Chigalayev
Phone +972544880543
Email Diana.Chigalayev@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2024
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy females, singleton pregnancy

- Planned elective C-section

- uncomplicated pregnancy

Exclusion Criteria:

- Donor positive for viruses tested

- Donor excessive smoker or drinker

- Donor known to carry mitochondrial disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Hospital- Tel Hashomer Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Minovia Therapeutics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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