N15-thymidine for Heart Muscle Regeneration

Overseen By Rashida Blackwood, BS, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Low resection chance

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment aimed at helping the heart regrow healthy muscle. It focuses on young patients with certain heart diseases who need surgery. Researchers aim to better understand heart muscle regeneration, especially since this ability decreases after birth. The study seeks infants between 30 days and 1 year old with heart conditions likely requiring surgery that involves removing some heart muscle. Participants will receive a special preparation called N15-thymidine (an experimental treatment) before their surgery to determine if it can boost heart muscle regrowth. As an unphased trial, this study offers a unique opportunity for patients to contribute to groundbreaking research on heart muscle regeneration.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that N15-thymidine is safe for heart muscle regeneration?

Research has shown that N15-thymidine, a treatment under study for heart muscle repair, tracks the growth of heart cells. In these studies, scientists mark N15-thymidine with special markers to observe heart cell division. This process is crucial for determining if the heart can heal itself.

Specific safety information from these studies is not yet available, but the use of these markers usually suggests a low-risk method. The study is labeled "Not Applicable" for phases, indicating a focus on understanding the treatment's mechanism rather than testing its safety in humans.

Without detailed safety information, assessing how well N15-thymidine is tolerated remains challenging. However, treatments reaching this stage are generally considered safe enough for further study. Prospective participants should discuss any concerns with their doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about N15-thymidine for heart muscle regeneration because it offers a fresh approach compared to traditional treatments like medications that manage symptoms or surgical interventions. Unlike these standard options, N15-thymidine aims to directly regenerate heart muscle tissue, potentially reversing damage rather than just alleviating symptoms. This treatment uses a novel active ingredient, thymidine, to promote the natural repair processes of the heart, which could lead to improved heart function and better outcomes for patients with heart conditions.

What evidence suggests that N15-thymidine might be an effective treatment for heart muscle regeneration?

Research has shown that N15-thymidine, which participants in this trial will receive, might help repair heart muscle by encouraging heart cell growth. In animal studies, a special form of thymidine boosted heart cell activity, suggesting it could regenerate heart muscle. Some trials reported positive results, with improved heart muscle function, although further research is needed to confirm these findings. Overall, this treatment aims to help the heart heal itself, offering hope for heart failure patients seeking new treatment options. ^{2 3 6 7 8}

Who Is on the Research Team?

Bernhard Kuhn, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for pediatric patients aged 30 days to 1 year who have heart conditions like Tetralogy of Fallot or Pulmonary Stenosis and are scheduled for elective cardiac surgery that includes myocardial resection. It's not specified who can't join because the exclusion criteria are missing.

Inclusion Criteria

My child is between 30 days and 1 year old and is scheduled for elective heart surgery.

My child is between 30 days and 1 year old and has a heart condition likely requiring surgery.

I have a heart condition likely needing surgery that involves heart muscle removal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive thymidine preparations for pre-defined blocks of time prior to the scheduled routine resection of myocardium

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• N15-thymidine

Trial Overview The study tests N15-thymidine, a marker used to measure new heart muscle cell growth in children with certain heart diseases. The goal is to understand how heart regeneration changes after birth and in disease.

How Is the Trial Designed?

Group I: N15-thymidine Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

California Institute of Technology

Collaborator

Trials

17

Recruited

4,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8221415/

Use of stable isotope-tagged thymidine and multi-isotope ... These results and others suggesting that cardiomyocytes regenerate after injury in neonatal mice and rats raise the tantalizing possibility that heart ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4435693/

Cardiac regeneration based on mechanisms of ... In mice, we administered isotope-labeled thymidine for 8 weeks to increase our sensitivity of detecting cardiomyocyte cell cycle activity. By MIMS analysis, we ...

3. mmrjournal.biomedcentral.com mmrjournal.biomedcentral.com/articles/10.1186/s40779-023-00452-0

Regeneration of the heart: from molecular mechanisms to ... One trial shows some positive results, but with an overall low engraft rate and lack of careful characterization of the control group [111].

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8896288/

Heart Regeneration: 20 Years of Progress and Renewed ... Studies to date suggest that cardiomyocyte replacement therapy can remuscularize the heart and improve systolic function, but this still needs to be confirmed ...

5. cellregeneration.springeropen.com cellregeneration.springeropen.com/articles/10.1186/s13619-021-00075-7

Molecular regulation of myocardial proliferation and ... In this brief review, we focus on the current understanding of the molecular and cellular mechanisms underlying CM proliferation and heart regeneration.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4418535/

An emerging consensus on cardiac regeneration - PMC A consensus has emerged that cardiomyocytes themselves are the most prominent source of ongoing cardiomyocyte renewal in the adult mammalian heart.

7. embopress.org embopress.org/doi/full/10.1002/emmm.201100175

Regeneration of the heart | EMBO Molecular Medicine In this review, we discuss the current status of research on cardiac regeneration, with a focus on the challenges that hold back therapeutic development.

8. sigmaaldrich.com sigmaaldrich.com/US/en/tech-docs/paper/302734?srsltid=AfmBOooPVQsZZF_Wb-aqxqCx87P7cyiU37JYcVj1b7WiVMFuKM71rExF

Regulation of neonatal and adult mammalian heart ... We conclude that the neonatal mammalian heart can regenerate after myocardial infarction through proliferation of preexisting cardiomyocytes and that the miR-15 ...