Cellular Therapy for In Utero Repair of Myelomeningocele

Status Recruiting

Clinical Trial Summary

Spina bifida, or myelomeningocele (MMC), is a disorder where the lower part of the spinal cord of the fetus is exposed, meaning there is no bone or skin covering it. This is dangerous because the spinal cord contains cells which control one's ability to move their legs and walk, and also to be able to urinate and have bowel movements normally. One of the current treatments for fetal MMC is to perform a surgery on the fetus before it is born which has many names including in utero surgery, prenatal surgery, or fetal surgery. This is a surgery that occurs inside the uterus (the womb) where the surgeon closes the opening in your fetus' back to cover the exposed spinal cord. Researchers have found that adding stem cells to the repair is effective in improving the ability of animals with MMC to walk, and that the stem cells are safe in animal studies. These stem cells are thought to protect the cells in the spinal cord that control movement and developmental outcomes. This study is being performed to look at the safety and effectiveness of stem cells on the fetus's exposed spinal cord during prenatal surgery.

Clinical Trial Description

Historically, treatment of MMC was limited to post-natal surgery to close the dura and skin over the spinal cord to prevent meningitis, which had no effect on motor function. The potential benefit of earlier intervention was realized when prenatal ultrasound of patients with MMC early in gestation revealed near-normal leg movements despite displaying paralysis at birth. This finding gave credence to the two-hit hypothesis that paralysis was progressive during prenatal life and suggested that fetal intervention could prevent the secondary damage to the spinal cord. Fetal repair of MMC did confer improvement in motor function of children treated in the Management of Myelomeningocele (MOMS) randomized controlled trial. The promising results of the MOMS trial demonstrated the potential for improvement of paralysis for these patients, but distal motor function still remained severely impaired in the majority of patients with MMC with standard in utero repair alone. While this demonstrated that the ideal time to intervene to prevent paralysis is in utero with the goal of preventing the accrual of ongoing damage to the spinal cord, there is still room for improvement. The remarkable regenerative capacity of the fetal environment combined with regenerative capacity of placental mesenchymal stem cells offers potential for augmentation of the fetal repair of MMC with a novel therapy to further reduce and repair the sustained spinal cord damage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04652908
Study type	Interventional
Source	University of California, Davis
Contact	Maria G Hernandez, CPT1
Phone	916-734-4156
Email	mghernandez@ucdavis.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	June 21, 2021
Completion date	March 2024

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See also
Status	Clinical Trial	Phase
Recruiting	`NCT06042140` - Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair	N/A
Recruiting	`NCT03562286` - Open Spina Bifida Fetoscopic Repair Project	N/A
Completed	`NCT04468568` - In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline
Recruiting	`NCT03856034` - Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele	N/A
Recruiting	`NCT04362592` - In-Utero Endoscopic Correction of Spina Bifida	N/A
Active, not recruiting	`NCT03936322` - Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study	N/A
Not yet recruiting	`NCT06405698` - Role of Perforator Flaps in Back Defects Reconstruction	N/A
Active, not recruiting	`NCT00175123` - Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele	Phase 4
Completed	`NCT02390895` - Prenatal Endoscopic Repair of Fetal Spina Bifida	N/A
Active, not recruiting	`NCT03090633` - Fetoscopic Repair of Isolated Fetal Spina Bifida	N/A
Not yet recruiting	`NCT03088761` - Cuff Pressure in Infants	N/A
Active, not recruiting	`NCT04484441` - Maternal-fetal Immune Responses to Fetal Surgery
Recruiting	`NCT04738539` - Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
Terminated	`NCT02493062` - Evaluation of Hysterotomy Site After Open Fetal Surgery	N/A
Completed	`NCT03550898` - Can Dynamic Ultrasonography Replace Urodynamics in Follow-up of Patients With Myelomeningocele	N/A
Active, not recruiting	`NCT04251806` - Sleep-disordered Breathing in Infants With Myelomeningocele
Terminated	`NCT02509377` - Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0	N/A
Recruiting	`NCT03788122` - Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery	N/A
Completed	`NCT02664207` - Extended Criteria For Fetal Myelomeningocele Repair	N/A
Recruiting	`NCT03315637` - Fetal Endoscopic Surgery for Spina Bifida	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms