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  • HP:0002475: Myelomeningocele
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    HP:0002475: Myelomeningocele

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

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    Correlated Drug Terms (1)


    Name (Synonyms) Correlation
    drug3292 Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix Wiki 1.00

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D016137 Spina Bifida Cystica NIH 1.00
    D008591 Meningomyelocele NIH 1.00

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Phase 1/2a Trial of Placental Mesenchymal Stem Cells for Repair of Fetal Myelomeningocele

    Spina bifida, or myelomeningocele (MMC), is a disorder where the lower part of the spinal cord of the fetus is exposed, meaning there is no bone or skin covering it. This is dangerous because the spinal cord contains cells which control one's ability to move their legs and walk, and also to be able to urinate and have bowel movements normally. One of the current treatments for fetal MMC is to perform a surgery on the fetus before it is born which has many names including in utero surgery, prenatal surgery, or fetal surgery. This is a surgery that occurs inside the uterus (the womb) where the surgeon closes the opening in your fetus' back to cover the exposed spinal cord. Researchers have found that adding stem cells to the repair is effective in improving the ability of animals with MMC to walk, and that the stem cells are safe in animal studies. These stem cells are thought to protect the cells in the spinal cord that control movement and developmental outcomes. This study is being performed to look at the safety and effectiveness of stem cells on the fetus's exposed spinal cord during prenatal surgery.

    NCT04652908
    Conditions
    1. Myelomeningocele
    Interventions
    1. Biological: Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix
    MeSH:Meningomyelocele Spina Bifida Cystica
    HPO:Myelocystocele Myelomeningocele

    Primary Outcomes

    Description: Will be assessed by evaluating the presence or absence of cerebrospinal fluid leak, infection at the MMC repair site, failure of the MMC repair site to heal, and any unexpected growths or tumor formation. These will be assessed at birth by physical exam, brain and spinal ultrasound , and brain and spinal MRI.

    Measure: Safety of the placenta-derived mesenchymal stem cell (PMSC-ECM) Product

    Time: Assessed at birth

    Secondary Outcomes

    Description: This is primarily evaluated by improvement in motor function 2 or more levels greater than expected by anatomic level of the defect and by patients' ability to walk independently. Bowel function will be assessed by caregiver questionnaires on bowel habits, and by anorectal manometry. Urologic function will be assessed by caregiver questionnaires regarding urologic function, by renal and bladder ultrasounds to evaluate for hydronephrosis and bladder abnormalities, and by video urodynamics.

    Measure: Efficacy of the PMSC-ECM Product

    Time: 30 months.

    HPO Nodes


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    Data processed on December 13, 2020.

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