US EditionIn-Utero Repair of Severe Spina Bifida With Stem Cells Shows Promise
Six fetuses with spina bifida received placenta-derived stem cells during prenatal surgery with no cell-related adverse events, all showing reversal of brain herniation at birth.
- Yesterday, The Lancet published initial CuRe phase 1 results showing the placenta‑derived mesenchymal stem cells appeared safe in six fetal surgeries at UC Davis, with no adverse events at birth.
- Driven by the 'two‑hit' hypothesis, researchers tested placenta‑derived mesenchymal stem cells because standard prenatal myelomeningocele repair prevents further damage but cannot reverse existing injury, and preclinical studies showed PMSCs have neuroprotective effects.
- Applying the graft during standard open fetal surgery, surgeons used a single dose of the PMSC‑ECM product seeded at 300,000 cells per cm2 from donated placentas tested 72 h before surgery between June 21, 2021 and Dec 5, 2022 at ~24–26 weeks gestation.
- Clinical outcomes showed postnatal MRI reversal of hindbrain herniation in every infant, no CSF shunting was needed, and the phase 1/2a trial enrolling 35 patients began with planned monitoring until age six.
- The investigators caution that the trial was not powered for efficacy and included six White non‑Hispanic participants, while phase 1/2a expansion and long‑term follow‑up plans are underway.
14 Articles
14 Articles
A clinical trial conducted in the United States shows the feasibility and lack of toxicity of this dual procedure. A French study evaluating a similar strategy is expected to begin by the end of 2026.
First-ever in-utero stem cell therapy for fetal spina bifida repair shows safe results
A Phase I clinical trial published in The Lancet has shown that combining stem cell therapy with standard fetal surgery before birth is a safe and promising approach to treat myelomeningocele, a severe form of spina bifida. This is the first time live stem cells have been used on a fetus's damaged spine, which could potentially lead to better health outcomes for babies compared to traditional fetal surgery.
MedPage Today
Bioethics.comIn-Utero Repair of Severe Spina Bifida With Stem Cells Shows Promise
(MedPage Today) -- In-utero treatment of myelomeningocele, the most severe form of spina bifida, with allogeneic, live stem cells was feasible and safe, a first in-human, phase I, single-arm study indicated. Myelomeningocele occurs when parts...
First-in-Human Success for Prenatal Stem Cell Therapy in Spina Bifida
For the first time ever, a stem cell therapy has been used to treat spina bifida in a fetus during pregnancy. Results from a Phase I clinical trial, published today in The Lancet, reveal that the treatment is safe and shows early signs of improving mobility and overall health after birth in six children with spina bifida treated using this novel approach. “By intervening at early stages of development, this approach has the potential to alter …
Coverage Details
Bias Distribution
- 75% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
