Spinal bifida is a neural tube birth defect in which the spinal cord and spine don't develop properly. Researchers conducted a clinical trial to investigate whether a patch made of umbilical cord placed on the spinal bifida defect after a minimally invasive fetoscopic surgery can improve healing.
The research was conducted at The University of Texas Health Science Center at Houston (UTHealth).
Currently, patients are enrolled at The Fetal Center affiliated with Children's Memorial Hermann Hospital, McGovern Medical School at UTHealth, and UT Physicians.
Ramesha Papanna, MD, MPH associate professor in the Department of Obstetrics, Gynecology and Reproductive Sciences with McGovern Medical School at UTHealth and maternal-fetal medicine specialist at UT Physicians said, "We've used umbilical cord patches before to close the skin when the gap was too large, but now we're assessing whether we can use this regenerative patch to promote healing and overcome the shortcomings of the minimally invasive approach, including scar formation at the repair site, which causes further complications."
Fetoscopic bifida repair is a minimally invasive investigational procedure using which surgeons can operate on the fetus. By using ultrasound as a guide, the surgeons make three small holes in the uterus at a distance of 3 to 4 mm from each other. Through this hole, a small camera and a surgical instrument can be inserted to close the defect.
This approach allows the mother the chance to have a vaginal birth and avoid another surgery. It also reduces the risk of uterine rupture in future pregnancies. The disadvantage of this approach is it is more difficult to achieve a watertight closure of spinal bifida as it does not allow much dexterity of the hand.
NEOX Cord 1KŪ human umbilical cord patch helps reduce the need for tissue closure, decreasing the risk of tissue damage, saving time and promote healing.
The researchers are investigating if this patch can prevent tethering. Tethering is the attachment of the spinal cord to scar tissue. Babies who undergo utero repair have tethering and a third of the children require surgery by age 10 for the tethered cord. Sometimes to release tethering, two to three surgeries are needed. With each surgery, children can lose functions like bladder control, mobility and walking.
Lovepreet Mann, MBBS came up with the idea of using the umbilical cord as it has anti-inflammatory, anti-scarring, and regenerative properties. Preclinical data showed the evidence of meningeal regeneration. Meningeal layer is the three layers of tissue that cover and protect the brain and spinal cord. This led to the idea of using meningeal patch.
To reduce scarring in burn patients, amniotic membrane is used. Amniotic membrane was also evaluated but it found to be too thin. Human umbilical cord has similar properties but is thicker and tougher.
US FDA has approved human umbilical patch for ophthalmological diseases. It improves inflammation which helps in regeneration.
In Phase I clinical trial, 15 patients have been enrolled and the success will be measured by intact repair defect, prevention of leakage of CSF, and how well the wound stays closed at the time of birth. To assess the functional outcomes, the study will follow children until 5 years of age.