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Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease

Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease

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Overview

The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology. This study will conduct a one-year safety follow-up of participants in "Efficacy and safety study of autologous cardiac stem cells (JRM-001) treated after reconstructive surgery in pediatric patients with congenital heart disease".

Eligibility

Inclusion Criteria:

  • Patients who participated in "Efficacy and safety study of autologous cardiac stem cells (JRM-001) treated after reconstructive surgery in pediatric patients with congenital heart disease" and meet the following criteria;
  • JRM-001 administration group: received JRM-001 investigational product after catheter examination
  • Non-administered group: underwent cardiac catheter examiniation only

Exclusion Criteria:

  • Patients who is difficult to visit the clinical trial site
  • Patients who is difficult to obtain the provision of medical information from clinical institute to which the patient is transferred

Study details
    Single Ventricle
    Hypoplastic Left Heart Syndrome (HLHS)

NCT07884318

Metcela Inc.

21 October 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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