Hypoplastic Left Heart SyndromePhase 3APOLLONNCT02781922
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
A Phase 3 study testing Autologous cardiac stem cells (JRM-001) in people with Hypoplastic Left Heart Syndrome and Single Ventricle, run by Metcela Inc. at 4 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle Read more about this study
- Who is it for?
- Ages 0 to 6 years
- Conditions the study is for
- Hypoplastic Left Heart Syndrome, Single Ventricle
- What is being tested?
- Autologous cardiac stem cells (JRM-001)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesJapan
- Study dates
- Jun 2016to Dec 2028
- Phase
- Phase 3
- 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 0 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
- EF(%) by echocardiography ≤ 55%
- Able to obtain written informed consent of participation in the study by a parent of the patient
Who cannot join
- Known medical history of cardiogenic shock
- Lethal, uncontrollable arrhythmia
- Complication of coronary artery disease
- Eisenmenger syndrome
- Complication of brain dysfunction due to circulatory failure
- Malignant neoplasm
Show all 15Show fewer
- Complication of severe neurologic disorder
- Severe pulmonary embolism or pulmonary hypertension
- Severe renal failure
- Multiple organ failure
- Active infection (including endocarditis)
- Sepsis
- Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury)
- Known history of hypersensitivity to anti-infective drugs
- Inability to complete the protocol treatment and baseline to follow-up examinations
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.) contact
Japan4 sites, 4 recruiting
- Recruiting
Kanagawa Children's Medical Center
Kanagawa
- Recruiting
Okayama University Hospital
Okayama
- Recruiting
Osaka Women's and Children's Hospital
Osaka
- Recruiting
Shizuoka Children's Hospital
Shizuoka
About this study
Official title: Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group Study
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Conditions
- Hypoplastic Left Heart Syndrome, Single Ventricle
- Being tested
- Autologous cardiac stem cells (JRM-001)
- Keywords
- cardiac stem/progenitor cells, autologous cell therapy, functional single ventricle, congenital heart disease
- Medical subject headings
- Hypoplastic Left Heart Syndrome, Univentricular Heart, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cardiac stem cells (JRM-001)Genetic
3x 10^5 cells/kg, single treatment
| Study group | Role | What they receive |
|---|---|---|
| Autologous cardiac stem cells (JRM-001) | Experimental | Not described Receives: Genetic: Autologous cardiac stem cells (JRM-001) |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ejection fraction (EF(%)) assessed by MRI from baseline
Measured: Baseline, 6 and 12 months
Secondary outcomes (7)
Change in EF(%) assessed by echocardiograms from baseline
Measured: Screening, Baseline, 3, 6 and 12 months
Change in EF(%) assessed by cardiac catheterization from baseline
Measured: Baseline, 6 and 12 months
Change in Ea/Ees assessed by cardiac catheterization from baseline
Measured: Baseline, 6 and 12 months
Change in Ventricular Stiffness assessed by cardiac catheterization from baseline
Measured: Baseline, 6 and 12 months
Change in heart failure index from baseline
Measured: Baseline, 3, 6 and 12 months
Change in Quality of Life (QOL) index from baseline
Measured: Baseline, 6 and 12 months
Number of adverse events
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypoplastic Left Heart SyndromeStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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
- NCT02781922
- Sponsor's protocol ID
- 001-CLJ-001
- Acronym
- APOLLON
- Status last verified
- Oct 2026
- First submitted
- 19 May 2016
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ishigami S, Ohtsuki S, Tarui S, Ousaka D, Eitoku T, Kondo M, Okuyama M, Kobayashi J, Baba K, Arai S, Kawabata T, Yoshizumi K, Tateishi A, Kuroko Y, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Circ Res. 2015 Feb 13;116(4):653-64. doi: 10.1161/CIRCRESAHA.116.304671. Epub 2014 Nov 17.
PubMed 25403163Tarui S, Ishigami S, Ousaka D, Kasahara S, Ohtsuki S, Sano S, Oh H. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1198-1207, 1208.e1-2. doi: 10.1016/j.jtcvs.2015.06.076. Epub 2015 Jul 8.
PubMed 26232942Ishigami S, Ohtsuki S, Eitoku T, Ousaka D, Kondo M, Kurita Y, Hirai K, Fukushima Y, Baba K, Goto T, Horio N, Kobayashi J, Kuroko Y, Kotani Y, Arai S, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary Cardiac Progenitor Cells in Single Ventricle Physiology: The PERSEUS (Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease) Randomized Phase 2 Trial. Circ Res. 2017 Mar 31;120(7):1162-1173. doi: 10.1161/CIRCRESAHA.116.310253. Epub 2017 Jan 4.
PubMed 28052915
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group Study
- ClinicalTrials.gov ID
- NCT02781922
- Acronym / sponsor ID
- APOLLON / 001-CLJ-001
- Conditions
- Hypoplastic Left Heart Syndrome, Single Ventricle
- Keywords
- cardiac stem/progenitor cells, autologous cell therapy, functional single ventricle, congenital heart disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Metcela Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 May 2016 (estimated)
- 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 purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous cardiac stem cells (JRM-001) | Experimental | Genetic: Autologous cardiac stem cells (JRM-001) |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 0 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
- EF(%) by echocardiography ≤ 55%
- Able to obtain written informed consent of participation in the study by a parent of the patient
Key exclusion criteria (15 listed)
- Known medical history of cardiogenic shock
- Lethal, uncontrollable arrhythmia
- Complication of coronary artery disease
- Eisenmenger syndrome
- Complication of brain dysfunction due to circulatory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous cardiac stem cells (JRM-001)3x 10^5 cells/kg, single treatment | Genetic | Autologous cardiac stem cells (JRM-001) |
Primary outcome
Change in ejection fraction (EF(%)) assessed by MRI from baseline
Time frame: Baseline, 6 and 12 months
7 secondary outcomes
Change in EF(%) assessed by echocardiograms from baseline
Time frame: Screening, Baseline, 3, 6 and 12 months
Change in EF(%) assessed by cardiac catheterization from baseline
Time frame: Baseline, 6 and 12 months
Change in Ea/Ees assessed by cardiac catheterization from baseline
Time frame: Baseline, 6 and 12 months
Change in Ventricular Stiffness assessed by cardiac catheterization from baseline
Time frame: Baseline, 6 and 12 months
Change in heart failure index from baseline
Time frame: Baseline, 3, 6 and 12 months
Change in Quality of Life (QOL) index from baseline
Time frame: Baseline, 6 and 12 months
Number of adverse events
Time frame: Up to 12 months
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 19 Oct 2026.
- Background: PubMed 25403163Ishigami S, Ohtsuki S, Tarui S, Ousaka D, Eitoku T, Kondo M, Okuyama M, Kobayashi J, Baba K, Arai S, Kawabata T, Yoshizumi K, Tateishi A, Kuroko Y, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Circ Res. 2015 Feb 13;116(4):653-64. doi: 10.1161/CIRCRESAHA.116.304671. Epub 2014 Nov 17.
- Background: PubMed 26232942Tarui S, Ishigami S, Ousaka D, Kasahara S, Ohtsuki S, Sano S, Oh H. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1198-1207, 1208.e1-2. doi: 10.1016/j.jtcvs.2015.06.076. Epub 2015 Jul 8.
- Background: PubMed 28052915Ishigami S, Ohtsuki S, Eitoku T, Ousaka D, Kondo M, Kurita Y, Hirai K, Fukushima Y, Baba K, Goto T, Horio N, Kobayashi J, Kuroko Y, Kotani Y, Arai S, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary Cardiac Progenitor Cells in Single Ventricle Physiology: The PERSEUS (Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease) Randomized Phase 2 Trial. Circ Res. 2017 Mar 31;120(7):1162-1173. doi: 10.1161/CIRCRESAHA.116.310253. Epub 2017 Jan 4.
- 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.
Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.) contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous cardiac stem cells (JRM-001) in people with Hypoplastic Left Heart Syndrome and Single Ventricle, run by Metcela Inc. at 4 sites 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 15 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 19 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 4 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.) (info@j-rm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ejection fraction (EF(%)) assessed by MRI from baseline (time frame: Baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781922, which also lists 3 linked publications.
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 19 Oct 2026.