Using stem cells to improve fetal surgery for spina bifida

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of placental mesenchymal stem cells in conjunction with fetal surgery to repair myelomeningocele, a severe form of spina bifida. Building on previous findings from the MOMS trial, which demonstrated some improvement in motor function with in-utero surgery, this study aims to enhance outcomes by adding stem cells to the surgical procedure. The trial will assess both the safety and efficacy of this combined approach in improving walking ability and overall motor function in affected infants. Participants will be monitored for improvements in their neurological function post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Eligibility for fetal surgery per the MOMS trial, which are:

* Myelomeningocele (including myeloschisis) at any level from T1 through S1 with hindbrain herniation. Lesion level will be confirmed by ultrasound and hindbrain herniation will be confirmed by MRI at the UC Davis Fetal Center
* Maternal age ≥18 years
* Gestational age at enrollment between 19 weeks 0 days and 25 weeks 6 days gestation as determined by clinical information and evaluation of first ultrasound
* Normal karyotype. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 24 weeks gestation;

Exclusion Criteria:

Not being eligible for fetal surgery per the MOMS trial, which includes:

* Multifetal pregnancy
* Insulin dependent pregestational diabetes
* Fetal anomaly not related to myelomeningocele.
* Kyphosis in the fetus of 30 degrees or more
* Current or planned cerclage or documented history of incompetent cervix, placenta previa or placental abruption
* Short cervix \< 20 mm measured by cervical ultrasound
* Obesity as defined by body mass index of 35 or greater
* Previous spontaneous singleton delivery prior to 37 weeks
* Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia
* Maternal HIV or Hepatitis-B status positive due to the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled
* Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened
* Uterine anomaly such as large or multiple fibroids or Müllerian duct abnormality
* Other maternal medical condition which is a contraindication to surgery or general anesthesia. This includes any patient with a previous hysterotomy in the active segment of the uterus (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery)
* Patient does not have a support person (e.g., husband, partner, mother)
* Inability to comply with the travel and follow-up requirements of fetal surgery
* Patient does not meet other psychosocial criteria (as determined by the psychosocial interviewer) to handle the implications of fetal surgery
* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy;
* Maternal hypertension which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy)
* Active COVID-19 infection at time of fetal surgery as determined by positive test

Where it's running

• UC Davis Health
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Diana L Farmer, MD — UC Davis School of Medicine
• Study coordinator: Amy B Powne, MSN, RN
• Email: fctc@health.ucdavis.edu
• Phone: 916-794-2229

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• tSCS for improving leg strength and walking in kids with spina bifida

  This pilot test will try non-invasive transcutaneous spinal cord stimulation to see if it helps improve leg muscle strength and walking in children with myelomeningocele who can walk a little with help.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07615686

• Transcutaneous spinal stimulation for children and teens with spina bifida

  This study will try gentle, non-invasive electrical stimulation of the spinal cord to see if it can strengthen legs and improve movement in children and teens with spina bifida.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT06918119

• Exploring the experiences of parents after fetal surgery for myelomeningocele

  This study is trying to understand how parents feel and what decisions they make before and after having surgery on their unborn baby to fix myelomeningocele.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Paris · NCT06796972

• Using cryopreserved human umbilical cord to repair spina bifida in fetuses

  This study is testing whether using preserved human umbilical cords can help repair spinal cord defects in fetuses with spina bifida to improve their health and development.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT06042140

• Comparing two surgical methods for correcting fetal myelomeningocele

  This study is testing two different surgical methods to see which one works better and is safer for fixing a serious birth defect called fetal myelomeningocele before the baby is born.

  Recruiting at 2 sites USFetus · Los Angeles, California and 1 other locations · NCT03856034

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.