A patch made from donor placental stem cells has been used to treat a fetus with a severe case of spina bifida.
In a pioneering trial, the innovative approach seems to have reversed a brain complication associated with the condition as effectively as standard treatment and could help more children walk in the future.
A UC Davis Health research team successfully achieved a groundbreaking first by combining fetal surgery with stem cell therapy for spina bifida.
The results are from Phase 1 of an ongoing clinical trial, as published in The Lancet.
The study tested whether adding a layer of human placenta-derived stem cells to standard fetal surgery could be performed safely.
Diana Farmer, the CuRe Trial’s principal investigator and chair of the UC Davis department of surgery, said: ‘Spina bifida can lead to a range of lifelong cognitive, mobility, urinary and bowel disabilities. Putting stem cells into a growing fetus was a total unknown. We are excited to report great safety.’
She added that it now paves the way for new treatment options for children with congenital disabilities.
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.
It is the world’s first in-utero stem cell therapy for spina bifida, and the only trial aimed at improving the outcomes for the children over fetal surgery alone.
The first six babies in the trial were monitored closely from surgery through birth.
All surgeries were successful, and the stem cell patch was placed as planned for every patient. All wounds were completely healed.
Because the early safety results were strong, the FDA and an independent monitoring board approved proceeding to the next phase of the study.
Photo caption - Diana Farmer, M.D., in surgery. Photo credit: UC Davis Health.credit: UC Davis Health.
