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Stem Cell Therapy
Stem Cell Therapy for Spina Bifida (CuRe Trial)
Phase 1 & 2
Recruiting
Led By Diana L Farmer, MD
Research Sponsored by Diana Lee Farmer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maternal age ≥18 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months.
Awards & highlights
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.
Who is the study for?
This trial is for pregnant women over 18 with a fetus diagnosed with myelomeningocele, confirmed by ultrasound and MRI. The gestational age must be between 19-25 weeks, and the fetus should have a normal karyotype. Women can't join if they have certain conditions like incompetent cervix, placenta issues, positive HIV/Hepatitis-B status or other medical conditions that increase surgery risks.Check my eligibility
What is being tested?
The CuRe Trial tests the safety and effectiveness of adding stem cells to prenatal surgery for fetal spina bifida repair. It compares outcomes in fetuses treated with stem cells on a dural graft matrix versus an untreated group to see if there's improved mobility and development.See study design
What are the potential side effects?
Since this is a new treatment being tested primarily for safety and effectiveness, potential side effects are not fully known but may include typical surgical risks such as infection or complications from anesthesia.
CuRe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
CuRe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of the placenta-derived mesenchymal stem cell (PMSC-ECM) Product
Secondary outcome measures
Efficacy of the PMSC-ECM Product
CuRe Trial Design
2Treatment groups
Experimental Treatment
Group I: non-PMSC untreated contemporaneous cohortExperimental Treatment1 Intervention
Contemporaneous cohort of patients undergoing routine fetal or postnatal MMC repair without PMSC-ECM (non-PMSC untreated contemporaneous cohort).
Group II: Treatment with PMSC-ECMExperimental Treatment1 Intervention
One-time administration of PMSC-ECM during the course of in utero fetal myelomeningocele surgery will be administered
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Who is running the clinical trial?
Diana Lee FarmerLead Sponsor
California Institute for Regenerative Medicine (CIRM)OTHER
65 Previous Clinical Trials
3,120 Total Patients Enrolled
Diana L Farmer, MDPrincipal InvestigatorUC Davis School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with PMSC-ECM
- Group 2: non-PMSC untreated contemporaneous cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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