Houston, TXNCT06042140Now EnrollingIRB Ready

Spina Bifida; Fetus Clinical Trial in Houston, TX

Access cutting-edge spina bifida; fetus treatment through this clinical trial at a research site in Houston. Study-provided care at no cost to qualified participants.

Sponsored by The University of Texas Health Science Center, Houston

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Expert Care in Houston

Access spina bifida; fetus specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related spina bifida; fetus treatment provided free

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Check if you qualify for this spina bifida; fetus clinical trial in Houston, TX

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Houston

    Convenient for TX residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Houston site if eligible
  4. 4Begin participation

About This Spina Bifida; Fetus Study in Houston

The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.

Sponsor: The University of Texas Health Science Center, Houston

Who Can Participate

Inclusion Criteria

Maternal Inclusion Criteria:
Singleton pregnancy
Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
Maternal age: 18 years and older
Body mass index ≤45 kg/m2 (pre-pregnancy)
No preterm birth risk factors (short cervix \<20 mm or a history of previous preterm delivery)
No previous uterine incision in the active uterine segment
Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful Fetal Inclusion Criteria:
Spina bifida defect between T1 to S1 vertebral levels
Chiari II malformation
No evidence of kyphosis (curved spine)
No major life-threatening fetal anomaly unrelated to spina bifida
Normal karyotype, or a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance \[fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks\].

Exclusion Criteria

Maternal Exclusion Criteria:
Non-resident of the United States
Multifetal pregnancy
Poorly controlled insulin-dependent pregestational diabetes
Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes
Current or planned cerclage or documented history of an incompetent cervix
Placenta previa or placental abruption
Short cervix of \< 20 mm
Obesity as defined by a body mass index of \> 45 kg/m2
Previous spontaneous singleton delivery prior to 37 weeks
Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
HIV or Hepatitis-B positive status
Known Hepatitis-C positivity
Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality that is diagnosed via imaging prior to surgery, which that are unavoidable during surgery
Other medical conditions which are contraindication to surgery or general anesthesia
Patient does not have a support person
Inability to comply with the travel and follow-up requirements of the trial
Patient does not meet psychosocial standardized assessment criteria
Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
Maternal hypertension
Zika virus positivity
Allergy/history of drug reaction to Amphotericin B Fetal exclusion criteria:
Major fetal anomaly not related to spina bifida
Kyphosis in the fetus of 30 degrees or more
Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints

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 Houston?

Yes, this clinical trial (NCT06042140) has an active research site in Houston, TX 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.

Spina Bifida; Fetus Treatment Options in Houston, TX

If you're searching for spina bifida; fetus treatment options in Houston, TX, this clinical trial (NCT06042140) 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 Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced spina bifida; fetus 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 spina bifida; fetus clinical trials near you to find additional studies recruiting in your area.

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