|Age:||Mom: 18 yrs and older|
|Keywords:||stem cell, Myelomeningocele, spina bifida, baby, in utero, fetal surgery|
|Type:||Phase 1/2a Safety Study|
You will undergo normal screening for fetal surgery to make sure you and your baby are good candidates for the surgery. The study team will review the full study participation requirements with you. Eligible patients will be enrolled in the trial following informed consent.
After the screening period, you will undergo the fetal surgery. During surgery the stem cells will be applied to your baby's spinal cord. Other than the addition of stem cells, the fetal surgery is the same surgery that is routinely done for babies with spina bifida.
You will have weekly follow-up visits with your care team from the time of fetal surgery until the delivery of your baby. This is normal after fetal surgery to monitor your baby's wellbeing. An ultrasound will be done each week to check on the baby. The study team will also ask about your health at each visit.
You will deliver your baby at UC Davis Medical Center by Cesarean section, which is needed after fetal surgery, at 37 weeks of gestation.
Your baby will be examined and undergo routine tests to see how they are doing. Some important tests include MRI images of the brain and spine, and X-rays of the spine.
You and your baby will also need to come in for visits at 3, 12, and 30 months old.
At these visits, your baby will undergo routine motor testing and developmental testing to track their development and progress.
At 12 months old, your baby will also have another spine X-ray and brain and spine MRI test to check for any potential negative effects of the stem cell treatment. Your baby will have some testing of their bowel and bladder systems, which control the ability to pee and poop. This includes tests and imaging, such as ultrasounds.
At 30 months old, more developmental tests will be done to track your baby's ability to move and walk. They will also have ultrasounds of their kidneys and bladder done.
In between these in-person visits, you will have follow-up phone or video visits at 6, 9, 18, and 24 months old to check on your baby.
After the 30 month visit, you and your child will be contacted yearly for follow-up through 6 years old. The study team will let you know what will happen at each of these visits when you meet with them.
All this information will be reviewed with you in more detail prior to starting the study.
Study candidates will include healthy pregnant women with fetuses diagnosed with MMC on prenatal ultrasound who meet criteria for open fetal repair.
Mothers must be 18 years or older
Fetuses must be between 19 weeks 0 days and 25 weeks 6 days gestation at the time of surgery
The study team will review the full participation requirements with you. You will be able to ask any questions before deciding to participate.
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.