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Collection of Placenta for Mitochondria Isolation

Sponsor
Minovia Therapeutics Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03762512
Collaborator
(none)
20
Enrollment
1
Location
72
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Collection of Placenta for Mitochondria Isolation for Use in Mitochondrial Augmentation
    Actual Study Start Date :
    Dec 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Placenta donated [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Hospital- Tel Hashomer Ramat Gan Israel

    Sponsors and Collaborators

    • Minovia Therapeutics Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Minovia Therapeutics Ltd.
    ClinicalTrials.gov Identifier:
    NCT03762512
    Other Study ID Numbers:
    • MNV-PLC-1
    First Posted:
    Dec 3, 2018
    Last Update Posted:
    Jun 22, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 22, 2020