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Stem Cell Therapy for Spina Bifida (CuRe Trial)
CuRe Trial Summary
This trial is testing a new treatment for spina bifida, which is a birth defect where the spinal cord is exposed. The treatment involves adding stem cells to the repair, which is effective in animals and is thought to be safe.
CuRe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCuRe Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CuRe Trial Design
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Who is running the clinical trial?
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- You are not eligible for fetal surgery, including if you are pregnant with more than one baby.My unborn baby has a condition unrelated to spinal defects.I cannot travel or follow the required check-ups for fetal surgery.I have or will have a stitch to support my cervix, or I've had issues with my cervix or placenta.I am 18 years old or older.You have a condition where a mother's and baby's blood types may cause complications during pregnancy.I have high blood pressure that could risk my pregnancy.Your cervix is shorter than 20 millimeters based on an ultrasound measurement.I know I am positive for Hepatitis C.I am not HIV or Hepatitis-B positive, or I have tested negative for both.You have a certain type of spinal defect and brain herniation that can be confirmed by ultrasound and MRI at a specific medical center.I am considered able to handle the implications of fetal surgery based on a psychosocial evaluation.I have a uterine condition, like fibroids or a Müllerian duct abnormality.The fetus has a spine curvature of 30 degrees or more.You have diabetes that requires insulin before becoming pregnant.I currently have an active COVID-19 infection.You are in the 19th to 25th week of pregnancy, based on clinical information and first ultrasound evaluation.Your chromosomes are normal, or if you are pregnant, certain test results are acceptable.I have a health condition that makes surgery or anesthesia risky, including a history of significant uterine surgery.You have a body mass index (BMI) of 35 or higher, which means you are very overweight.You have given birth to a single baby early, before 37 weeks of pregnancy, without any medical intervention.
- Group 1: Treatment with PMSC-ECM
- Group 2: non-PMSC untreated contemporaneous cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other experiments have been conducted utilizing Placental Mesenchymal Stem Cells seeded on a marketable dural graft extracellular matrix?
"Currently, 3 trials for Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix are in progress. One of these is at the Phase 3 level and all 21 locations involved are located across Kfar-Saba and Colorado."
Does this investigation represent a pioneering effort?
"At the moment, there are three active clinical trials related to Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix, located in 6 cities and countries. The first such trial originated back in 2018 under the sponsorship of Pluristem Ltd., ultimately involving 240 participants that completed Phase 3 drug approval stage. Since then, 4 more studies have been successfully conducted."
What is the maximum capacity of individuals participating in this experiment?
"Affirmative. The details on clinicaltrials.gov demonstrate that this experiment, which was launched in June of 2021, is still looking for participants. Consequently, 55 individuals from a single medical centre need to be recruited."
Are there any opportunities to participate in this investigation?
"Affirmative. According to information provided on clinicaltrials.gov, this medical trial is actively enrolling patients and was first published on June 21st 2021. Subsequently updated on September 1st 2022, the study needs 55 enrollees from a single location."
What criteria must individuals meet to be eligible for entry into this clinical experiment?
"This trial is seeking 55 individuals between 19 and 25 weeks of gestation with a diagnosis of myelomeningocele. Additionally, participants must have their gestational age confirmed by both clinical information and the initial ultrasound performed upon enrollment."
Is there an age cap for individuals to be eligible to partake in this experiment?
"Patients eligible to take part in this medical trial must be between 19 weeks and 25 weeks of age. Separately, 6 clinical trials are available for those younger than 18 years old and 7 more have been created for elderly individuals aged 65 or above."
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