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

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"Volunteer to participate in groundbreaking research at UC Davis, with the goal of improving function for babies with spina bifida."
Age: Mom: 18 yrs and older
Gender:
Female
Healthy Volunteers: No
Keywords: stem cell, Myelomeningocele, spina bifida, baby, in utero, fetal surgery
Type: Phase 1/2a Safety Study
Target:
35 Participants
Investigators:
Description
Myelomeningocele (MMC), a severe form of spina bifida, is a birth defect in which the spinal canal does not close normally before birth. This means that the spinal cord is exposed with no protective covering during the pregnancy. This damages the spinal cord and nerve roots. Due to this, children born with MMC are often paralyzed (cannot walk) and cannot control their bowel movements or urination.

Fetal repair of MMC is a surgery where surgeons open the uterus and close the opening in the baby's back. Studies have shown that fetal repair offers better results than repair after the baby is born. Fetal repair improves the chances that the baby can walk and not need a shunt to drain extra fluid that accumulates in the brain. Currently, fetal repair is the recommended surgery for babies with spina bifida.

We developed a new product that contains stem cells from placentas (PMSCs) which showed promising results when given to animals with spina bifida. Animals that had PMSCs applied to their spinal cord before birth were able to walk. This study will test these stem cells (PMSCs) in human babies with MMC. We will find out if adding stem cells during the fetal MMC repair will help children walk and control their bowel movements and urination.

Since this a new study, the babies will be monitored very closely to look for improvement or for any side effects. Essentially, we hope that fetal repair with the stem cells will improve these baby's lives.
This study requires

Screening & Informed Consent

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.

Surgery

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.

Weekly Follow-Up Visits

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.

Delivery & Additional Follow-Up Visits

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.

Who can participate

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.

Benefits and risks of participating
BENEFITS:

Our hope is that prenatal repair with the PMSC-ECM will eliminate the disabilities associated with MMC entirely, but any improvement in function is meaningful for children and their families.

RISKS:

Open fetal surgery comes with a known set of risks to you and your baby. The study team will discuss all risks to you and your baby during the evaluation process.
Compensation
Compensation for housing and foods costs will vary.

The study team will review compensation and expense reimbursements with you during the evaluation.
Resources
Schedule
Study duration and period
Complete evaluation, fetal surgery, post operative management, delivery and follow-up visits or phone calls for 6 years of child's life
Recruitment period
From March 1, 2021
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Myelomenigocele
  • spina bifida

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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