Three babies have been born after receiving an experimental stem cell treatment for spina bifida while still in the womb — the first time this approach has been tested in a human clinical trial. The early results, from UC Davis Health’s CuRe trial, are cautiously promising, and researchers say the first child treated showed leg movement at birth that would not have been expected without the intervention.
At a glance
- Spina bifida treatment: The CuRe trial applies a patch containing mesenchymal stem cells directly to the fetus’s spine during surgery performed around the midpoint of pregnancy, aiming to repair nerve damage before birth.
- Clinical trial results: The first baby, treated at 25 and a half weeks gestation in July 2021 C.E., was expected to be born with leg paralysis — yet she was observed kicking and wiggling her toes immediately after birth.
- In utero surgery: The full trial will enroll 35 patients, with researchers monitoring each child until age six, including a key developmental checkpoint at 30 months to assess walking ability and toilet training.
What spina bifida takes from families
Spina bifida is a birth defect in which the spine fails to close and develop properly during early pregnancy. It can cause weakness or paralysis of the lower limbs, cognitive difficulties, and urinary and bowel dysfunction. There is no cure.
Post-birth surgery can ease some symptoms, but the nerve damage that accumulates in the womb during fetal development is difficult to undo after the fact. That gap — between what surgery after birth can accomplish and what might be possible with earlier action — is exactly what the CuRe trial is designed to close.
Because spina bifida shows signs early in pregnancy, there is a window during which a developing fetus can still receive treatment. The CuRe trial, which stands for Cellular Therapy for In Utero Repair of Myelomeningocele, was built around that window.
How the stem cell patch works
Parents enrolled in the trial undergo surgery roughly midway through pregnancy. Surgeons carefully apply a patch containing mesenchymal stem cells to the affected section of the fetus’s spine while it is still in the womb. The stem cells are intended to support tissue repair in a way that standard prenatal surgery alone cannot achieve.
The approach did not come without precedent. Earlier studies in sheep and dogs born with spina bifida showed that the technique could prevent paralysis — those young animals walked without noticeable disability following treatment. That animal data gave the UC Davis team enough confidence to move into a human trial.
Mesenchymal stem cells are known for their ability to reduce inflammation and support tissue regeneration. In the context of spina bifida, the hope is that delivering them directly to the spine at the right moment in development will limit the nerve damage that otherwise accumulates before birth.
Three births, one milestone moment
Of the 35 patients the CuRe trial will eventually enroll, three had delivered as of the initial reporting. The first baby treated — a girl who received the stem cell patch in July 2021 C.E. at 25 and a half weeks gestation — was born that September. Based on the severity of her condition, clinicians had anticipated she would be born with leg paralysis. Instead, she was kicking and wiggling her toes right after birth.
That is a striking early signal. It is not, the researchers are careful to say, a conclusion.
The team at UC Davis Health will follow each child until age six, with a structured milestone at 30 months to evaluate walking and toilet training — two outcomes that matter enormously to families living with spina bifida. The scientists have been explicit about the need for caution, and the full picture will take years to form.
Why the timeline matters
One of the most significant aspects of the CuRe trial is not just what it does, but when. The field of fetal medicine has expanded the idea of what is treatable before birth, and each advance in that space shifts the horizon for what medicine can offer families who receive difficult diagnoses during pregnancy.
Prenatal surgery for spina bifida — without the stem cell component — has already been shown to reduce the need for surgery after birth and improve some neurological outcomes. The CuRe trial is asking whether adding stem cells to that procedure produces better results still.
If the trial bears out its early promise across all 35 enrolled patients, it could establish a new standard of care for a condition that currently offers families few options. That is a significant if, and the researchers at UC Davis Health are not claiming more than the data currently shows. But the fact that a baby expected to be born without the ability to move her legs was kicking at birth is, at minimum, worth watching closely.
One real limitation remains: the trial is still in early stages, with only three births reported so far and a long monitoring period ahead. Whether the benefits observed at birth persist through childhood, and whether the procedure is equally effective across the full range of spina bifida severity, are questions the trial has not yet answered.
Read more
For more on this story, see: New Atlas — World-first stem cell therapy trial treats spina bifida before birth
For more from Good News for Humankind, see:
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- The Good News for Humankind archive on global health
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