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Outcomes

The UTHealth Houston Fetal Institute is preparing the next generation of care providers by developing tools, treatments, and sustainable solutions to advance fetal diagnosis and therapy.

Fetoscopic Myelomeningocele Repair

UTHealth Houston was the first academic institution in the United States to offer fetoscopic repair using an innovative cryopreserved human umbilical cord (HUC) patch in a surgery performed at a quaternary medical center.

Based on more than a decade of research, and after successful completion of an early feasibility trial to establish safety of the procedure, the Fetal Institute actively enrolling patients in “Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair (HUC-FICS Trial).”

The study is a U.S. Food and Drug Administration-approved Phase III trial under the Investigational Device Exemption.

All HUC trials have been led by Ramesha Papanna, MD, MPH, professor of maternal-fetal medicine and UTHealth Houston Chair in Fetal Intervention, who is internationally recognized for his research on improving outcomes following fetal intervention and investigating methods for the prevention of preterm delivery.

About the Innovative Repair Procedure and HUC Patch

The fetoscopic procedure differs from in-utero repair, which requires a large incision on the uterus and delivery by cesarean section. Instead, the UTHealth Houston team repairs the spina bifida defect in two layers through three small incisions in the uterus using a fetoscope, high-resolution camera, and tiny surgical tools. The first layer is closed using the HUC patch placed over the spinal cord, followed by a second layer of primary closure of the skin. If the skin defect is large, the surgeons may use a second patch. Mothers, including those who come from other states, return home for the remainder of the pregnancy and undergo vaginal delivery, unless there is an obstetrical indication for delivery by C-section.

Working as a team, they open the abdomen, make small incisions in the uterus to introduce fetoscopes and instruments, visualize the spina bifida defect using heated humidified carbon dioxide gas, release the neural placode, and sew the patch in place over the defect.

Made from the donated umbilical cord tissue of healthy newborns, the HUC patch acts as a watertight scaffold, allowing native tissue to regenerate in an organized manner, resulting in a spinal cord repair that appears more normal with better function.

HUC Patch Outcomes

As of April 9, 2024:

  • 83 cases completed
  • No fetal deaths or perinatal deaths
  • Of 76 babies delivered, 49% were delivered vaginally at an average of 35 weeks 0 days, 28% PPROM
  • No cerebrospinal fluid leakage at birth
  • CSF diversion/shunt rates: 20% before NICU discharge and 44% at 12 months of age
  • Release of tethered cord
    • 0% have required surgery for the tethered cord before 12 months of age
    • 2 have had tethered cord release at more than 12 months of age
  • Ambulation and lower motor function studies are ongoing.