The study, called “Feasibility and Safety of Cellular Therapy for In-Utero Repair of Myelomeningocele (CuRe Trial): a First-In-Human, Phase 1, Single-Arm Study," tested whether adding a layer of human placenta-derived stem cells to standard fetal surgery could be done safely. Spina bifida, also known as myelomeningocele, occurs when spinal tissue fails to fuse properly during the early stages of pregnancy. The birth defect can lead to a range of lifelong cognitive, mobility, urinary and bowel disabilities.
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During fetal surgery, a small opening is made in the uterus. The surgeons then float the fetus up to that incision point so they can expose the back of the fetus and the spina bifida defect. The care team places a small patch containing living stem cells directly over the fetus’s exposed spinal cord, before closing the layers of the back to allow the tissue to regenerate. The stem cells, taken from donated placentas, are designed to protect the developing spinal cord from further damage before birth.