Long-term safety follow-up after autologous cardiac stem cells in kids with single ventricle heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study designed to monitor the long-term safety of JRM-001, autologous cardiac stem cells, in pediatric patients with single ventricle physiology following reconstructive surgery. Participants from the prior efficacy and safety study will have a one-year safety follow-up, focusing on adverse events and tolerability. The study compares those who received JRM-001 after catheter examination to those who had a catheter exam without the cell therapy. No specific intervention beyond follow-up testing is described, and data collection is anchored at visits in Okayama, Japan. The sponsor is Metcela Inc., with Okayama University Hospital as the site.

Why it matters

Who can join: the full rules

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

Where it's running

• Okayama University Hospital
  Okayama, Okayama-ken, Japan Recruiting

Study contacts

• Study coordinator: Clinical Trial Inquiry Contact
• Email: info@j-rm.com
• Phone: 81-44-201-1376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.