Umbilical Cord Patch for Spina Bifida
(HUC-FICS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Disqualifiers: Diabetes, Hypertension, Obesity, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have poorly controlled diabetes or certain infections, you may not be eligible to participate.
What data supports the effectiveness of the treatment for spina bifida?
Research in animal models suggests that using a cryopreserved human umbilical cord (HUC) patch for spina bifida repair may improve neurological outcomes and reduce inflammation and scarring compared to other materials. This could potentially lead to better spinal cord function and fewer complications like tethered cord syndrome.
12345Is the umbilical cord patch safe for use in humans?
The studies primarily focus on animal models, but they suggest that the cryopreserved human umbilical cord patch has regenerative, anti-inflammatory, and anti-scarring properties, which are generally positive indicators for safety.
12345How is the umbilical cord patch treatment for spina bifida different from other treatments?
The umbilical cord patch treatment for spina bifida is unique because it uses a cryopreserved human umbilical cord, which has regenerative, anti-inflammatory, and anti-scarring properties, providing a watertight repair and potentially improving neurological outcomes compared to other materials like acellular dermal matrix.
12346Eligibility Criteria
This trial is for pregnant women with a single fetus diagnosed with spina bifida, between 19 and 25+ weeks gestation. Women must be over 18, have a BMI ≤45 kg/m2 without preterm birth risks or previous uterine incisions in the active segment. The fetus should have the defect between T1 to S1 vertebral levels without severe kyphosis or other life-threatening anomalies.Inclusion Criteria
Fetal Inclusion Criteria: No evidence of kyphosis (curved spine)
Fetal Inclusion Criteria: No major life-threatening fetal anomaly unrelated to spina bifida
Maternal Inclusion Criteria: No preterm birth risk factors (short cervix <20 mm or a history of previous preterm delivery)
+9 more
Exclusion Criteria
Maternal Exclusion Criteria: Maternal hypertension
Maternal Exclusion Criteria: Patient does not have a support person
Maternal Exclusion Criteria: Multifetal pregnancy
+21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a laparotomy-assisted fetoscopic surgical approach using cryopreserved human umbilical cords as a meningeal and skin patch for spina bifida repair
1 week
Follow-up
Participants are monitored for safety and effectiveness after the surgical procedure
4 weeks
Participant Groups
The study tests using cryopreserved human umbilical cords (NEOX Cord 1K®) as patches during fetoscopic surgery to repair spinal defects caused by spina bifida. It aims to see if this method is effective when applied via laparotomy-assisted fetoscopy.
1Treatment groups
Experimental Treatment
Group I: NEOX Cord 1K applied fetoscopicallyExperimental Treatment1 Intervention
Patients intending to undergo open in-utero spina bifida repair will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Pediatric Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled.
Cryopreserved Human Umbilical Cord is already approved in United States for the following indications:
🇺🇸 Approved in United States as NEOX Cord 1K for:
- Spina bifida repair under Investigational Device Exemption
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
Loading ...
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
Allografts for Skin Closure during In Utero Spina Bifida Repair in a Sheep Model. [2021]Use of off-label tissue graft materials, such as acellular dermal matrix (ADM), for in utero repair of severe spina bifida (SB), where primary skin layer closure is not possible, is associated with poor neurological outcomes. The cryopreserved human umbilical cord (HUC) patch has regenerative, anti-inflammatory, and anti-scarring properties, and provides watertight SB repair. We tested the hypothesis that the HUC is a superior skin patch to ADM for reducing inflammation at the repair site and preserving spinal cord function.
Neurological Outcomes after Human Umbilical Cord Patch for In Utero Spina Bifida Repair in a Sheep Model. [2022]The objective of our study was to test the hypothesis that in utero repair of surgically created spina bifida in a sheep model using cryopreserved human umbilical cord (HUC) patch improves neurological outcome.
Cryopreserved human umbilical cord as a meningeal patch during in utero spina bifida repair in a modified ovine model. [2023]Despite in utero spina bifida (SB) repair, more than two-thirds of patients with SB are unable to ambulate independently, and 1 in 4 children need surgery for tethered cord by school age. The objective of this study was to test the cryopreserved human umbilical cord (HUC) as an antiscarring material to reduce tethering and improve function in a modified in utero SB repair model.
Cryopreserved human umbilical cord versus acellular dermal matrix patches for in utero fetal spina bifida repair in a pregnant rat model. [2020]Despite significant improvement in spinal cord function after in utero spina bifida (SB) repair compared with traditional postnatal repair, over half of the children who undergo this procedure do not benefit completely. This lack of benefit has been attributed to closure methods of the defect, with subsequent spinal cord tethering at the repair site. Hence, a regenerative patch or material with antiinflammatory and anti-scarring properties may alleviate comorbidities with improved outcomes. The authors' primary objective was therefore to compare cryopreserved human umbilical cord (HUC) versus acellular dermal matrix (ADM) patches for regenerative repair of in utero SB lesions in an animal model.
Generation of Induced Pluripotent Stem Cells and Neural Stem/Progenitor Cells from Newborns with Spina Bifida Aperta. [2022]We established induced pluripotent stem cells (iPSCs) and neural stem/progenitor cells (NSPCs) from three newborns with spina bifida aperta (SBa) using clinically practical methods.
Prenatal and Postnatal Imaging Findings After Fetal Repair of Spinal Dysraphisms Using Cryopreserved Human Umbilical Cord Patch: A Case Series of 4 Patients. [2021]We describe a case series of imaging findings of 4 patients who underwent spinal dysraphisms repair in utero with novel patch material, cryopreserved human umbilical cord, in our institution. In our study, the prenatal and postnatal magnetic resonance imaging and ultrasound are reviewed and showed cord tethering and syrinx progression in all cases. Our report is the first description of magnetic resonance imaging and ultrasound findings in the context of using this novel patch in severe cases of spinal dysraphisms.