Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Longeveron Inc.
With
National Heart, Lung, and Blood Institute (NHLBI)
Ann & Robert H Lurie Children's Hospital of Chicago
The University of Texas Health Science Center, Houston
Age
0–1
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Inclusion:
All participants must have HLHS (includes all types) requiring Stage II palliation (Glenn or Hemi-Fontan operation).
Exclusion:
1. Requirement for ongoing mechanical circulatory support immediately prior to Stage II palliation within 5 days
2. Need for concomitant surgery for aortic coarctation or tricuspid valve repair or Endocardial fibroelastosis (EFE) resection or left ventricle recruitment procedures
3. Undergoing the Stage I (Norwood) procedure that does not have HLHS
4. Serum positivity for: human immunodeficiency virus (HIV); hepatitis B virus surface antigen (HBV BsAg); and/or viremic hepatitis C virus (HCV). This criterion can be ascertained by one of three ways:
1. Documented history of mother's testing conducted during pregnancy
2. Documented history of participants testing.
3. If above documentation is not available blood will be obtained from participant at Screening/Baseline.
5. Parent/guardian that is unwilling or unable to comply with necessary follow-up
6. Unsuitability for the study based on the Investigator's clinical opinion
7. Known hypersensitivity to dimethyl sulfoxide (DMSO)
8. Presence of a pacemaker, or anticipated placement of a pacemaker, at the time of the Stage II palliation
