FDA approves UTHealth Houston expansion of unique in utero spina bifida repair study using an umbilical cord patch
Three families in three different states all share one thing in common – their children were diagnosed with spina bifida in utero.
Through their journey to find help, the families were referred to Ramesha Papanna, MD, a maternal-fetal surgeon with McGovern Medical School at UTHealth Houston and The Fetal Center at Children's Memorial Hermann Hospital, where they enrolled in a one-of-a-kind fetoscopic spina bifida study using cryopreserved umbilical cord.
Now, over a year later, 1-year-olds Lily Nail from Oklahoma, Harper Burch from Missouri, and Wyatt Carpenter from Texas are thriving. The procedure, approved by the U.S. Food and Drug Administration (FDA), is testing whether the regenerative approach allows better preservation of neural tissue and reduces long-term complications from scar tissue including tethering of the spinal cord.
“We felt blessed to be presented with a less-invasive surgery option and the opportunity to give Wyatt a chance,” said Sarah Carpenter, Wyatt’s mom. “All of these possibilities gave us hope. Wyatt is our little miracle and we are so thankful for the trial. He reminds us every day what it means to have faith in God, research, and medicine.”
After successful completion of the single-site feasibility study, led by Papanna, which included 25 patients, the FDA gave approval to expand the study to 50 patients.
Papanna, a professor in the Department of Obstetrics, Gynecology and Reproductive Science at McGovern Medical School, is internationally recognized for his research on improving outcomes following fetal intervention and investigating methods for the prevention of preterm delivery.
“This approach, compared to open fetal surgery where we have to make a bigger incision on the uterus, allows the mother the chance to have a vaginal birth and avoid another surgery,” said Papanna, who sees patients at UT Physicians. “It also reduces the chances of uterine rupture in future pregnancies.”
The team for the surgery includes pediatric neurosurgeons Stephen Fletcher, DO, and Brandon Miller, MD, PhD; pediatric surgeons KuoJen Tsao, MD, and Mary Austin, MD; and maternal-fetal surgeon Eric P. Bergh, MD. All are faculty members of McGovern Medical School.
The method was tested in preclinical studies over 10 years in collaboration with physician-scientist Lovepreet Mann, MBBS, co-investigator on the study and an assistant professor in the Department of Obstetrics, Gynecology and Reproductive Sciences.
“Results from the feasibility trial, which opened in 2020, were promising. It is our hope that these children will be able to have better neurological outcomes and less need for surgery of a tethered spinal cord later in life,” Papanna said.
Previous patients enrolled in the trial were required to return to Houston at 34 weeks for delivery and neonatal care. Based on the safety results of the first 25 patients in the study, new patients can return home two weeks after surgery and delivery locally if specialized care is available at the referring center.
Patients who enroll in the study will be requested to return to Houston when the child is 12 months old for a comprehensive evaluation and MRI of the head and spine to assess efficacy, including spinal cord tethering and function.
For more information on how to enroll, call 832-500-6423 or visit the website.
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