A Study to Evaluate Neurodevelopmental Outcomes in Children with Hypoplastic Left Heart Syndrome After Delivery of Autologous Umbilical Cord Derived Mononuclear Cells During Cardiac Surgery

Overview

About this study

The purpose of this study is to assess neurodevelopmental and psychosocial outcomes (i.e., executive function, social cognition, psychosocial adjustment, adaptive skills) in children with hypoplastic left heart syndrome (HLHS) who underwent right-ventricle-directed delivery of autologous umbilical cord derived mononuclear cells during staged cardiac surgical palliation, and to compare their outcomes to a matched sample of children with HLHS who did not receive autologous umbilical cord derived mononuclear cells during surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria;

Children with Hypoplastic Left Heart Syndrome who received umbilical cord derived mononuclear cells during cardiac surgery.
Children with Hypoplastic Left Heart Syndrome, matched in age and cardiac medical/surgical history, who did not receive mononuclear cells during surgery.
Ages 2 - 5.
Parent(s) fluent in English and/or Spanish.

Exclusion Criteria:

Status post heart transplant.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Adam Cassidy, Ph.D., L.P.	Closed for enrollment	Contact information: Lori Riess CCRP (507) 538-7730 hlhs@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adam Cassidy, Ph.D., L.P.

Closed for enrollment

Contact information:

Lori Riess CCRP

(507) 538-7730

hlhs@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials