Fetal surgery for spina bifida stops nerve damage but cannot reverse it, leaving nearly 60% of children unable to walk. The CuRe Trial changed that equation by adding stem cells during in-utero repair for the first time, and early results published in The Lancet show meaningfully better motor outcomes.
How the CuRe Trial Worked
Researchers at UC Davis Health asked whether placental mesenchymal stem cells, applied directly to the exposed spinal cord during fetal surgery, could push neurological repair beyond what surgery alone achieves.
Pregnant women carrying fetuses with spina bifida underwent procedures between 19 and 26 weeks of gestation. The stem cells were selected for three biological roles: reducing inflammation that compounds nerve damage, secreting growth factors that support neural repair, and modulating the immune environment to favor healing.
Motor level outcomes were, on average, one to two neurological levels better than predicted, a clinically meaningful difference that could translate into greater mobility and independence. The stem cell group also needed fewer postnatal shunt placements, which matters because shunt surgery carries serious risks and many children require multiple revisions throughout their lives.
No significant increase in maternal or fetal complications was observed. The FDA has approved progression to Phase 2.
What the Results Actually Mean
Up to 80% of affected children develop hydrocephalus, a dangerous fluid buildup in the brain that often requires surgical shunt placement. Reducing that burden is a major secondary win from these findings.
Phase 1 trials are designed for safety and signal detection, not definitive proof. The sample size is small, follow-up extends only to 12 months, and comparisons relied on historical rather than randomized controls. Larger trials are needed before this becomes standard care. What the CuRe Trial offers is a credible shift in direction: from protecting the fetus against damage to actively repairing neural tissue before birth.
