Recruiting

Regenerative Therapies

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06587165

Conditions

Tetralogy of Fallot With Pulmonary Stenosis

Heart Failure

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

N15-thymidine

Study Details

Brief summary:

Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. The investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration.

The study has now been registered on ClinicalTrials.gov, despite its initiation on July 23, 2015, as registration was not mandated at the original study site, the University of Pittsburgh Medical Center. However, following the transfer of the study to Weill Cornell Medicine, adherence to institutional requirements necessitated its registration on ClinicalTrials.gov.

Conditions

Tetralogy of Fallot With Pulmonary Stenosis

Heart Failure

Study ID

NCT06587165

Start date

May 15, 2026

Status verified date

Jun, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients at 30 days of age to 1 year of age undergoing scheduled elective cardiac surgery will be eligible for study inclusion.
  • The investigators will recruit patients at 30 days of age to 1 year of age with those types of heart disease whose surgical approach has a high probability of myocardial resection.
  • Diagnosis of ToF/PS or other types of heart disease that have a high likelihood of requiring surgery that involves routine resection of myocardium that becomes available for research

Exclusion Criteria:

  • Patients with low chance of having resection of myocardium as part of their surgical care.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: N15-thymidine

Study participants will receive thymidine preparations for pre-defined blocks of time prior to the scheduled routine resection of myocardium.

Interventions

N15-thymidine

50mg/kg (oral administration)

Primary outcome measure

  • Percentage of labeled cardiomyocytes for each patient [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Rashida Blackwood, BS, MPH

646-962-9036rab4029@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Rashida Blackwood

6469629036rab4029@med.cornell.edu

Principal Investigator:

Bernhard Kuhn, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-15.