2016 Spina Bifida Clinical Study

We are pleased to be a part of clinical trials for a new method of treating babies with spina bifida via fetal surgeries that will seek FDA approval to be used in the US. Spina bifida is a birth defect in which an area of the spinal column doesn’t form properly, leaving a section of the spinal cord and spinal nerves exposed through an opening in the back. One of the most common surgeries to correct this involves a surgery (laparotomy) where there is incision across the mother’s abdomen, the uterus is opened and a pediatric neurosurgeon returns the spinal cord to the spinal canal, and closes the surrounding tissue and skin over the defect to protect the spinal cord from exposure to the amniotic fluid. The uterus and the abdominal incision are then closed. Anytime the uterus is opened there is a significant risk to the mother and baby.The object of this study is to find a way to perform a similar surgery via fetoscopy (surgery that is minimally invasive where there are small incisions made and the fetus is not removed from the uterus) and different materials used as a safer option for mothers and babies. Working with Dr. Ruben Quintero and a world renowned lab we are funding the toxicity testing required to gain FDA approval to move onto the next phase of this trial. Results should be available in late 2016.