Phase 12a Study of Placental Stem Cell Therapy Added to Fetal Surgery for Myelomeningocele Repair

What this Trial Is About

Spina bifida, specifically myelomeningocele MMC, is a birth defect causing paralysis, excess brain fluid, and difficulty with bladder and bowel control. Past research showed that surgery before birth reduces the need for brain fluid shunting and slightly improves walking, but most children still cannot walk unassisted. This research investigates whether adding living placental stem cells to fetal MMC repair can enhance walking ability and nerve function by protecting and repairing the spinal cord during early development. The study involves a one-time application of placental mesenchymal stem cells seeded on a dural graft during open fetal surgery to repair MMC. This is compared to a group receiving standard fetal or postnatal MMC repair without stem cells. The stem cell product is tailored and placed on the spinal cord during surgery, followed by standard fetal surgical closure and uterine repair. Participants will undergo fetal surgery and monitoring, with assessments at birth and follow-up at 30 months to evaluate safety and effectiveness. Researchers will assess the safety of the stem cell treatment at birth and measure its impact on motor function and other outcomes up to 30 months. This trial includes detailed clinical evaluations and ongoing monitoring to understand the treatments effects over time.

Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial