Stem cells given during infant heart surgery: a safety first

NCT ID NCT04236479

Ongoing Disease control Sponsor: Catherine Bollard Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests whether giving stem cells (from a donor) during heart-lung bypass surgery is safe for infants under 6 months with certain congenital heart defects. Seventeen infants will receive the cells while undergoing heart repair. The main goal is to check for serious side effects, with a secondary look at brain development and recovery.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Allogeneic bone marrow-derived mesenchymal stromal cells (stem cells)
What this could lead to: If safe, this could lead to a new way to protect the brain and heart in infants undergoing complex heart surgery.
What could go wrong: This is a very early, small safety trial with only 17 infants. It is not designed to prove effectiveness, and there may be unknown side effects from the stem cells.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for CONGENITAL HEART DISEASE (CHD) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CONGENITAL HEART DISEASE (CHD)

Contacts and locations

Locations

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.