Umbilical Cord Blood Therapy for Hypoplastic Left Heart Syndrome

N/A

Recruiting

Led By Susana Cantero Peral, M.D., Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant woman with a prenatal diagnosis of severe CHD/hypoplastic left heart syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing the feasibility of using cells from umbilical cord blood to repair damage from congenital heart disease.

Who is the study for?

This trial is for parents of babies diagnosed prenatally with hypoplastic left heart syndrome, who are willing to have their baby's umbilical cord blood collected and stored for research on cardiac repair. Parents must agree to follow-up questions about the baby's health status.Check my eligibility

What is being tested?

The study tests the collection, processing, and storage of umbilical cord blood from newborns with hypoplastic left heart syndrome. The goal is to see if these cells can be used in future therapies aimed at repairing congenital heart defects.See study design

What are the potential side effects?

Since this trial involves collecting umbilical cord blood without direct intervention on the infant or mother, there are no anticipated side effects related to typical drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant and my baby has been diagnosed with severe CHD or hypoplastic left heart syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of cells that are viable following post thaw analysis

Percent of samples contaminated

Trial Design

1Treatment groups

Experimental Treatment

Group I: Umbilical Cord Blood CollectionExperimental Treatment1 Intervention

Umbilical Cord Blood is drawn from the umbilical cord of newborn babies diagnosed with Hypoplastic Left Heart Syndrome, before placental detachment. Cord blood is packaged in a Credo Cube, and sent at a temperate state to the manufacturer immediately after draw. At least 65 mL of cord blood is needed to produce a stem cell product during manufacturing. Once processed, the patient's autologous cord blood stem cells will be frozen for their potential future use in a clinical trial.

0 / 1Eligibility criteria met