Umbilical Cord Patch for Spina Bifida

Overseen By Stephen Fletcher, DO

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Steroid therapy

Disqualifiers: Sepsis, Infection, Congenital anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate postnatal period

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the impact of an autologous umbilical cord patch for dural closure on the repair of open neural tube defect. The outcomes will evaluate successful defect closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications, but it excludes those who have used steroid therapy during pregnancy, except for lung maturity. It also excludes those treated with investigational drugs that could affect health outcomes.

What data supports the effectiveness of the treatment Autologous Human Umbilical Cord Tissue Patch for spina bifida?

Research suggests that using a human umbilical cord patch for spina bifida repair can improve neurological outcomes and reduce inflammation and scarring at the repair site, compared to other materials. This is based on studies in animal models, which show that the patch helps preserve spinal cord function and may lead to better overall results. ^{1 2 3 4 5}

Is the umbilical cord patch safe for use in humans?

The studies available focus on animal models and do not provide direct safety data for humans. However, the human umbilical cord patch is noted for its regenerative, anti-inflammatory, and anti-scarring properties, which are generally positive indicators for safety in medical applications. ^{1 2 3 5 6}

How 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 reducing inflammation and spinal cord tethering compared to traditional methods. ^{1 2 4 5 7}

Research Team

Stephen Fletcher, DO

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals with open neural tube defects like Spina Bifida or Tethered Cord Syndrome. It's specifically looking at those who can provide their own umbilical cord tissue for the procedure.

Inclusion Criteria

Resident of the United States

Provision of signed and dated informed consent form

Stated willingness by legally authorized representative (LAR) to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Febrile or other acute illness of the neonate at time of delivery

My baby has a major birth defect not related to spina bifida that could affect surgery safety.

Vaginal delivery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an autologous umbilical cord patch for dural closure to repair open neural tube defects

Immediate postnatal period

Follow-up

Participants are monitored for successful defect closure, spinal canal capacity, and inflammatory response

6 months

Treatment Details

Interventions

• Autologous Human Umbilical Cord Tissue Patch

Trial Overview The study tests using a patient's own umbilical cord tissue as a patch to repair an open neural tube defect, aiming to see if it leads to better outcomes compared to past methods.

Participant Groups

Group I: Autologous umbilical cord patch Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

The study found that using cryopreserved human umbilical cord (HUC) patches for in utero repair of spina bifida resulted in significantly better spinal cord function in lambs compared to acellular dermal matrix (ADM) patches, as measured by the Texas Spinal Cord Injury Scale.

Histological analysis showed that the HUC group had lower levels of inflammation and fewer activated astrocytes compared to the ADM group, indicating that HUC patches may provide a more effective and safer option for reducing inflammation and preserving neurological function during spina bifida repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allografts for Skin Closure during In Utero Spina Bifida Repair in a Sheep Model. Mann, LK., Won, JH., Patel, R., et al.[2021]

In a study comparing cryopreserved human umbilical cord (HUC) patches to acellular dermal matrix (ADM) patches for repairing in utero spina bifida defects in rats, the HUC patches resulted in lower inflammation and apoptosis, indicating a safer and more effective option for repair.

The HUC patches also promoted better cellular organization and growth, suggesting they could improve spinal cord function and reduce complications like tethering compared to ADM patches, making them a promising material for future spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryopreserved human umbilical cord versus acellular dermal matrix patches for in utero fetal spina bifida repair in a pregnant rat model. Mann, LK., Won, JH., Trenton, NJ., et al.[2020]

In a study involving pregnant ewes, using a cryopreserved human umbilical cord patch to repair surgically created spina bifida significantly improved neurological outcomes compared to unrepaired cases, as indicated by higher Texas Spinal Cord Injury Scale scores and partial bladder control.

Lambs that received the HUC patch showed complete healing of skin defects and better overall survival rates, suggesting that this intervention could be a promising approach for treating spina bifida in utero.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological Outcomes after Human Umbilical Cord Patch for In Utero Spina Bifida Repair in a Sheep Model. Papanna, R., Mann, LK., Snowise, S., et al.[2022]

Using cryopreserved human umbilical cord (HUC) as a meningeal patch in a modified spina bifida repair model significantly improved spinal cord function compared to conventional repair methods, as shown by higher Texas Spinal Cord Injury Scale scores.

The HUC patch reduced spinal cord tethering and promoted better regeneration of the arachnoid layer, indicating its potential as a safer and more effective option for in utero spina bifida repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryopreserved human umbilical cord as a meningeal patch during in utero spina bifida repair in a modified ovine model. Mann, LK., Won, JH., Garnett, J., et al.[2023]

In a study using Sprague-Dawley rats with induced spina bifida, cryopreserved human umbilical cord (HUC) patches significantly promoted the migration of native cells and showed minimal inflammatory response compared to biocellulose film (BCF) patches.

HUC patches demonstrated effective cellular migration of epithelial, astrocyte, and endothelial cells, suggesting that HUC may be a superior material for prenatal spina bifida repair due to its regenerative properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryopreserved human umbilical cord versus biocellulose film for prenatal spina bifida repair in a physiologic rat model. Snowise, S., Mann, L., Morales, Y., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Allografts for Skin Closure during In Utero Spina Bifida Repair in a Sheep Model. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Cryopreserved human umbilical cord versus acellular dermal matrix patches for in utero fetal spina bifida repair in a pregnant rat model. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Neurological Outcomes after Human Umbilical Cord Patch for In Utero Spina Bifida Repair in a Sheep Model. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Bioengineering of Fetal Skin: Differentiation of Amniotic Fluid Stem Cells into Keratinocytes. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Cryopreserved human umbilical cord as a meningeal patch during in utero spina bifida repair in a modified ovine model. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Cryopreserved human umbilical cord versus biocellulose film for prenatal spina bifida repair in a physiologic rat model. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Experimental tissue engineering of fetal skin. [2022]