Single VentricleNCT07884318
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
An observational study of Single Ventricle and Hypoplastic Left Heart Syndrome (HLHS), run by Metcela Inc. at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 1 Sep 2026to 28 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants in "Efficacy and safety study of autologous cardiac stem cells (JRM- 001) treated after reconstructive surgery in pediatric patients with congenital heart disease"
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Okayama University Hospital, 81-86-235-7534, chiken@okayama-u.ac.jp
About this study
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".
- Keywords
- cardiac stem cells, autologous cell therapy, congenital heart diseases
- Medical subject headings
- Univentricular Heart, Hypoplastic Left Heart Syndrome, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| JRM-001 administration Group | 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". | |
| Non-administeration Group | 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". |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Sep 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single VentricleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metcela Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884318
- Sponsor's protocol ID
- 001-CLJ-002
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07884318
- Acronym / sponsor ID
- 001-CLJ-002
- Keywords
- cardiac stem cells, autologous cell therapy, congenital heart diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Metcela Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JRM-001 administration Group | – | –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". |
| Non-administeration Group | – | –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". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in "Efficacy and safety study of autologous cardiac stem cells (JRM- 001) treated after reconstructive surgery in pediatric patients with congenital heart disease"
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse events or serious adverse events (SAE)
Time frame: From enrollment to the end of treatment at 12 months
Any adverse events or serious adverse events (SAE) occurred till months 12 of this study (corresponding to 24 months after JRM-001 administration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Ventricle and Hypoplastic Left Heart Syndrome (HLHS), run by Metcela Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Inquiry Contact (81-44-201-1376, info@j-rm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events or serious adverse events (SAE) (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.