Researchers at McGovern Medical School at UTHealth affiliated with Children’s Memorial Hermann Hospital, are now enrolling patients in a study to determine the feasibility of fetoscopic surgery to repair spina bifida and facilitate vaginal delivery. The single-center study is led by Ramesha Papanna, MD, MPH, an associate professor of maternal-fetal medicine who is internationally recognized for his research on improving outcomes following fetal intervention and investigating methods for the prevention of preterm delivery.
“Our primary outcome measure for the study is successful surgical closure of the spina bifida defect with a watertight patch that approximates native tissue and allows for the natural growth of the spinal cord,” Dr. Papanna says. “The procedure differs from in-utero repair, which requires a large incision on the uterus and delivery by cesarean section. Instead, we will repair the spina bifida defect in two layers through three small incisions in the uterus using fetoscopes and tiny surgical tools. The first layer will be closed using a NEOX®Cord 1K patch as a meningeal patch placed over the spinal cord, followed by a second layer of primary closure of the skin. Mothers will undergo vaginal delivery, unless there is an obstetrical indication for delivery by C-section.”
The NEOX Cord 1K patch is made of cryopreserved umbilical cord and amniotic membrane. Extensive laboratory and clinical research on an ocular wound surface has shown that placental tissues help manage inflammation in wounds, facilitate cell proliferation and create an environment for tissue regeneration. NEOX Cord 1K has demonstrated consistently high closure rates in real-world experiences.
The study, the first to use a meningeal patch to cover the spina bifida defect, will enroll 15 patients, age 18 and older with a singleton pregnancy, a spina bifida defect of 4 centimeters or less and no preterm birth risk factors. Participants also must meet other study qualifications.
A digital image of the fetal repair site will be captured immediately after the repair, and efficacy of the fetoscopic repair will be assessed after birth by three blinded reviewers. Reviewing neurosurgeons are Arthur Day, MD, McGovern Medical School and UTHealth Neurosciences in Houston; Bradley Edward Weprin, MD, UT Southwestern Medical Center in Dallas; and John Honeycutt, MD, Cook Children’s Hospital in Dallas.
Patients referred to The Fetal Center at Children’s Memorial Hermann Hospital who intend to undergo open in-utero spina bifida repair will be offered and screened for the alternative minimally invasive approach. Women who participate in the study must agree to deliver at Children’s Memorial Hermann Hospital.
“We have published promising preclinical data and have rigorously tested our techniques before taking fetoscopic repair to humans,” Dr. Papanna says. “Our research is changing the way we approach spina bifida to improve closure, reduce scar tissue formation, reduce neurological deficits and improve function. With this trial we hope to show that the NEOX Cord 1K patch optimizes long-term outcomes for these kids.”
When you contact The Fetal Center, you will be in touch with a dedicated coordinator who will walk you through the process step-by-step and help you to understand every aspect of your care.
The Fetal Center at Children's Memorial Hermann Hospital
UT Professional Building
6410 Fannin, Suite 210
Houston, Texas 77030
Phone: (832) 325-7288
Toll free: (888) 818-4818
Fax: (713) 383-1464
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Located within the Texas Medical Center, The Fetal Center is affiliated with McGovern Medical School at UTHealth Houston, UT Physicians and Children’s Memorial Hermann Hospital.