Quantifying New Heart Muscle Cells

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06587165
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Days - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • N15-thymidine — OTHER
    50mg/kg (oral administration)

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
May 15, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: N15-thymidine
    Study participants will receive thymidine preparations for pre-defined blocks of time prior to the scheduled routine resection of myocardium.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Columbia University (Morgan Stanley Children's Hospital)New YorkNew York10032
Maureen McKiernan, MD
Katrina Golub, MPH
Maureen McKiernan, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Rashida Blackwood
6469629036
Bernhard Kuhn, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Laura Mercer-Rosa, MD
Anh Duc Mai, MS
Laura Mercer-Rosa, MD (PRINCIPAL_INVESTIGATOR)
Upmc Children'S Hospital of PittsburghPittsburghPennsylvania15224
Shannon Janzef, MSN, RN, CBC
Mousumi Moulik (PRINCIPAL_INVESTIGATOR)

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