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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 University of California, Davis
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
Must not have
Current or planned cerclage or documented history of incompetent cervix, placenta previa or placental abruption
Uterine anomaly such as large or multiple fibroids or Müllerian duct abnormality
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months.
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or will have a stitch to support my cervix, or I've had issues with my cervix or placenta.
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I have a uterine condition, like fibroids or a Müllerian duct abnormality.
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I have a health condition that makes surgery or anesthesia risky, including a history of significant uterine surgery.
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My unborn baby has a condition unrelated to spinal defects.
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I cannot travel or follow the required check-ups for fetal surgery.
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I have high blood pressure that could risk my pregnancy.
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I currently have an active COVID-19 infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of the placenta-derived mesenchymal stem cell (PMSC-ECM) Product
Secondary study objectives
Efficacy of the PMSC-ECM Product

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
943 Previous Clinical Trials
4,755,633 Total Patients Enrolled
Diana Lee FarmerLead Sponsor
California Institute for Regenerative Medicine (CIRM)OTHER
69 Previous Clinical Trials
3,303 Total Patients Enrolled

Media Library

Cellular Therapy (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04652908 — Phase 1 & 2
Spina Bifida Research Study Groups: Treatment with PMSC-ECM, non-PMSC untreated contemporaneous cohort
Spina Bifida Clinical Trial 2023: Cellular Therapy Highlights & Side Effects. Trial Name: NCT04652908 — Phase 1 & 2
Cellular Therapy (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04652908 — Phase 1 & 2
~15 spots leftby Mar 2026
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