The purpose of this study is to determine the impact of an autologous umbilical cord patch for dural closure on the repair of open neural tube defect. The outcomes will evaluate successful defect closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Surgery will occur from birth to 24 hours of age. The autologous umbilical cord patch is harvested at time of delivery and immediately processed in a sterile setting in order to create a dural patch as a spinal cord cover to close the developmental defect within a few hours after birth.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGNumber of participants that have wound dehiscence
Time frame: one-month post-op
Number of participants that have wound dehiscence
Time frame: 1-year post-op
Number of participants that have Cerebrospinal fluid (CSF) leakage
Time frame: one-month post-op
Number of participants that have CSF leakage
Time frame: 1-year post-op.
Number of participants that present with tethered cord syndrome
Time frame: one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op
Number of participants that had a change in level of neurological function as assessed by the American Spinal Injury Association Impairment Scale (ASIA)
Time frame: baseline, one-month post-op,12-months post-op
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