Clinical trialNCT01883076CompletedPhase 1Interventional

Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome

SponsorTimothy J Nelson, MD, PhDEnrollment30Hypoplastic Left Heart Syndrome

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn surgical procedure. The investigators are doing this research study to find out if autologous stem cells from the individual's own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment for the management of HLHS.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David M Overman, M.D.
Children's Hospitals and Clinics of Minnesota
Principal Investigator
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Harold M Burkhart, M.D.
Oklahoma University Children's Hospital
Principal Investigator
clinicaltrials.gov ↗
James Jaggers, M.D.
Children's Hospital Colorado
Principal Investigator
clinicaltrials.gov ↗
Joseph W Rossano, M.D.
Children's Hospital of Philadelphia
Principal Investigator
clinicaltrials.gov ↗
Muhammad Y Qureshi, MBBS
Mayo Clinic
Principal Investigator
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Ram Kumar Subramanyan, M.D., Ph.D.
Children's Hospital Los Angeles
Principal Investigator
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Timothy J Nelson, M.D., Ph.D.
Mayo Clinic
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital Los Angeles
Los Angeles, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Children'S Hospital of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Oklahoma University Children'S Hospital
Oklahoma City, Oklahoma, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Autologous cell-based delivery

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 May 2013
Primary completion: 28 Apr 2021
Completion: 28 Apr 2021
Last update posted: 29 Apr 2022
Registered enrollment: 30
Registry id: NCT01883076

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.