An observational study in Single Ventricle and Hypoplastic Left Heart Syndrome (HLHS), sponsored by Metcela Inc.. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Metcela Inc. · Observational
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".
108 studies on the registry are indexed under Univentricular Heart; 23 are open to participants now.
This study's planned enrollment of 40 is below the median of 48 across 45 observational studies indexed under Univentricular Heart.
Browse Univentricular Heart studies →Metcela Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants in "Efficacy and safety study of autologous cardiac stem cells (JRM- 001) treated after reconstructive surgery in pediatric patients with congenital heart disease"
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who were administered JRM-001 in the study "Efficacy and safety study of autologous cardiac stem cells (JRM-001) treated after reconstructive surgery in pediatric patients with congenital heart disease".
Patients who were not administered JRM-001 in the study "Efficacy and safety study of autologous cardiac stem cells (JRM-001) treated after reconstructive surgery in pediatric patients with congenital heart disease".
Adverse events or serious adverse events (SAE)
Any adverse events or serious adverse events (SAE) occurred till months 12 of this study (corresponding to 24 months after JRM-001 administration)
Time frame: From enrollment to the end of treatment at 12 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Metcela Inc.