Is NCT04652908 recruiting in Sacramento, CA?

Yes, NCT04652908 is currently recruiting participants at its Sacramento, CA location. This myelomeningocele clinical trial is actively enrolling qualified participants.

How do I join the myelomeningocele clinical trial in Sacramento?

To join this clinical trial in Sacramento, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Sacramento clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Myelomeningocele Clinical Trial in Sacramento, CA

About This Myelomeningocele Study in Sacramento

Spina bifida, or myelomeningocele (MMC), is a birth defect that results in paralysis, excess fluid on the brain (hydrocephalus), and impaired ability to urinate and have bowel movements normally. In a previous study (the MOMS trial), surgery before birth (in-utero/fetal surgery) was shown to reduce the need for shunting for hydrocephalus. There was also some improvement in ambulation, but 58 % of the children still could not walk unassisted. This study is testing living stem cells from placenta added to the fetal repair in an effort to improve the ability to walk. Previous animal studies have shown dramatic improvement in walking and bowel and bladder function when placental stem cells are added to MMC repair. Use of these "living" cells may protect the developing spinal cord, prevent further injury, and may even reverse existing damage to the nerves that control movement. This study is assessing the safety and efficacy of adding stem cells to open fetal surgery for MMC in humans.

Sponsor: University of California, Davis

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Sacramento?

Yes, this clinical trial (NCT04652908) has an active research site in Sacramento, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Myelomeningocele Treatment Options in Sacramento, CA

If you're searching for myelomeningocele treatment options in Sacramento, CA, this clinical trial (NCT04652908) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Sacramento research site is actively enrolling participants for this clinical trial. You'll receive care from experienced myelomeningocele specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all myelomeningocele clinical trials near you to find additional studies recruiting in your area.

Myelomeningocele Clinical Trial in Sacramento, CA

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