iPSC Repository of Pediatric Cardiovascular Disease

Heart Diseases Clinical Trial

Official title:

iPSC Repository of Pediatric Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550324
• Other study ID #: STUDY00001788
• Status: Recruiting
• Start date: July 2, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: Jade F Hayden, BSN
• Phone: 16143555648
• Email: jade.hayden[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obtain blood samples for generation and maintenance of induced pluripotent stem cells (iPSCs) and genomic/DNA sequencing for biomedical research that will improve the understanding and treatment of pediatric cardiovascular disease

Description:

Human induced pluripotent stem cells (iPSCs) are a type of pluripotent stem cell which can be generated from easily accessible patient cells, such as peripheral blood mononuclear cells and skin fibroblasts. As iPSCs are epigenetically reprogrammed from somatic cells, they retain all genetic information of the affected patients, thus providing an ideal model for studying the contribution of genetic variation to pediatric cardiovascular disease. In addition, human iPSCs can be differentiated into cardiomyocytes, endothelial cells, smooth muscle cells and cardiac fibroblasts, which are major affected cell types in the heart responsible for cardiovascular disease. Therefore, patient-specific iPSCs possess great promise in modeling pediatric cardiovascular disease, discovering novel drugs and prospective cell regeneration therapy. The DNA from these patients will be analyzed for point mutations, rare sequence variations, single nucleotide polymorphisms in known cardiac development genes or for chromosomal copy number changes by using state of the art genetic approaches.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. The subjects must have the diagnosis of cardiovascular disease

2. The subject must have a syndrome associated with cardiovascular disease

3. The subject must be related to an individual in cohort 1 or 2

4. The subject is considered a control and does not fall into any of the other cohorts Exclusion Criteria: N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Blood draw
One time intravenous blood draw

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mingtao Zhao

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improve the understanding and treatment of pediatric cardiovascular disease	This is a repository of blood samples that will be used into the future for medical research to improve the understanding and treatment of pediatric cardiovascular disease	up to 10 Years