[Articles] Feasibility and safety of cellular therapy for in-utero repair of myelomeningocele (CuRe Trial): a first-in-human, phase 1, single-arm study

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Source: The Lancet

Original: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02466-3/fullt...

Published: 2026-02-28

The CuRe Trial is the first human clinical trial to combine fetal surgery with cell therapy for the treatment of myelomeningocele (spinal fissure)[3][4]. The study tests the safety and efficacy of placental mesenchymal stem cells (PMSC) placed on a special patch during surgery in the uterus[1][2]. Initial safety data from the first seven patients showed that the treatment showed no cell-related adverse effects and was deemed safe to continue with the study[2]. The main goal is to improve children's motor function, specifically their ability to walk independently and control bowel and urinary function[1]. The study plans to enroll a total of 35 patients in the treatment group and 20 patients in the control group without cell therapy[1]. The results will be evaluated in a 30-month horizon after the birth of the child[1]. The current standard of fetal surgery without cell therapy leaves 58% of patients unable to walk independently, highlighting the need for this new treatment[2].