Umbilical Cord Patch for Spina Bifida
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assist babies born with spina bifida, a condition where the spine doesn't form properly. Researchers are using an Autologous Human Umbilical Cord Tissue Patch, made from the baby's own umbilical cord, to determine if it can more effectively close the spinal defect, create additional space in the spinal canal, and reduce inflammation compared to previous methods. Babies diagnosed with spina bifida before birth and meeting specific health criteria may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research that could enhance future treatment options for spina bifida.
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 prior data suggests that this umbilical cord patch is safe for spina bifida repair?
Research has shown that using a patch made from a patient's own umbilical cord tissue is generally safe. Studies have found that patients usually tolerate this type of patch well, with no serious side effects. Past studies reported no unexpected health problems, suggesting that these patches might be a safe option for treating conditions like spina bifida, where the spine does not develop properly. It is important to consult a healthcare provider to understand the potential risks and benefits for each specific situation.
Why are researchers excited about this trial?
Unlike the standard surgical treatments for spina bifida, which often involve closing the defect with synthetic materials or skin grafts, the umbilical cord patch is derived from the patient's own umbilical cord tissue. This unique approach offers a personalized treatment, which may reduce the risk of rejection and infection. Researchers are excited because this method could promote better healing and integration with the body, potentially leading to improved outcomes for babies born with spina bifida.
What evidence suggests that the autologous umbilical cord patch is effective for spina bifida?
Research has shown that using a patch made from a baby's own umbilical cord tissue for treating spina bifida looks promising. In this trial, participants will receive an autologous umbilical cord patch. Previous studies found that this type of patch can effectively close the openings in the spine. Since the patch is made from the baby's own tissue, it might lower the risk of rejection or cause less swelling and irritation compared to other materials. Early findings suggest that it can help enlarge the spinal canal, benefiting the spinal cord's function. While more research is needed, these results offer hope for better outcomes in treating spina bifida.
Who Is on the Research Team?
Stephen Fletcher, DO
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an autologous umbilical cord patch for dural closure to repair open neural tube defects
Follow-up
Participants are monitored for successful defect closure, spinal canal capacity, and inflammatory response
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Human Umbilical Cord Tissue Patch
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor