Spina Bifida Treatment Approved by FDA for Human Clinical Trials

Shriners Hospitals for Children — Northern California’s surgeon in chief, Diana L. Farmer, M.D., FACS, FRCS, and principal investigator for the Institute for Pediatric Regenerative Medicine, Aijun Wang, Ph.D., have received approval for a human clinical trial from the U.S. Food and Drug Administration (FDA) to test a groundbreaking spina bifida treatment that combines surgery with stem cells.

“We are incredibly excited about this approval from the FDA because we have been working for years to prepare for clinical trials,” said Dr. Farmer.

The one-of-a-kind treatment, delivered while the baby is still in the mother’s womb, could improve outcomes for children with the spina bifida birth defect.

Spina bifida occurs when spinal tissue improperly fuses during the early stages of pregnancy, leading to a range of lifelong cognitive, mobility, urinary and bowel disabilities. It affects thousands of children each year in the U.S.

Dr. Farmer and Dr. Wang’s work has been funded by the National Institutes of Health, California Institute for Regenerative Medicine and Shriners Hospitals for Children.

Dr. Farmer has been researching and working with children with spina bifida and their families throughout her career. She has a deep passion for finding a cure and has greatly contributed to the course of treatment for her patients. As a leader of the MOMS trial, she proved that repairing the spinal cord in utero surgery reduced the neurological deficits of spina bifida.

In collaboration with Shriners Hospitals for Children — Northern California, director of pediatric surgery and pediatric surgeon, Shinjiro Hirose, M.D., and Dr. Farmer launched the UC Davis Children’s Hospital fetal care and treatment center to provide comprehensive diagnostic, medical and surgical solutions for fetal, newborn and pediatric conditions. Follow-up care for children takes place at Shriners Hospitals for Children — Northern California’s spina bifida clinic, which recently received national recognition from the Spina Bifida Association.

For more information about spina bifida, our team and the spina bifida clinic and program, visit the spina bifida care webpage.