The procedure administers stem cells derived from placental tissue to babies in the womb. Researchers hope to repair the defect that occurs when the protective tissue around a baby’s developing spinal cord fails to fully close before birth.
During the procedure, the fetal surgeon places a biological scaffold of placental mesenchymal stem cells directly over the exposed spinal cord. The surgeon then closes the opening in the baby’s back to allow the tissue to regenerate and protect the infant’s spinal cord.
The three babies who underwent the procedure will be monitored by the research team until 30 months of age to fully evaluate the safety and effectiveness of the treatment.
Spina bifida, also known as myelomeningocele, occurs when spinal tissue fails to fuse properly during the early stages of pregnancy, according to Sacramento, Calif.-based UC Davis Health. The birth defect can lead to various cognitive, mobility, urinary and bowel disabilities. It affects 1,500 to 2,000 children in the U.S. a year and is often diagnosed through ultrasound.
The California Institute for Regenerative Medicine provided a $9 million grant to Diana Farmer, MD, professor and chair of surgery at UC Davis Health, and Aijun Wang, PhD, associate professor of surgery and biomedical engineering at the health system, to fund the clinical trial.
Thirty-five patients will be treated in the study.
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