Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial) (APOLLON)
September 24, 2025 updated by: Metcela Inc.
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.)
- Email: info@j-rm.com
Study Locations
-
-
-
Kanagawa, Japan
- Recruiting
- Kanagawa Children's Medical Center
-
Okayama, Japan
- Recruiting
- Okayama University Hospital
-
Saitama, Japan
- Recruiting
- Saitama Prefectural Children's Medical Center
-
Shizuoka, Japan
- Recruiting
- Shizuoka Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 2 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care
|
|
|
Experimental: Autologous cardiac stem cells (JRM-001)
|
3x 10^5 cells/kg, single treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in ejection fraction (EF(%)) assessed by MRI from baseline
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in EF(%) assessed by echocardiograms from baseline
Time Frame: Screening, Baseline, 3, 6 and 12 months
|
Screening, Baseline, 3, 6 and 12 months
|
|
Change in EF(%) assessed by cardiac catheterization from baseline
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in Ea/Ees assessed by cardiac catheterization from baseline
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in Ventricular Stiffness assessed by cardiac catheterization from baseline
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in heart failure index from baseline
Time Frame: Baseline, 3, 6 and 12 months
|
Baseline, 3, 6 and 12 months
|
|
Change in Quality of Life (QOL) index from baseline
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Number of adverse events
Time Frame: Up to 12 months
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ishigami 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.
- Tarui 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
May 19, 2016
First Submitted That Met QC Criteria
May 20, 2016
First Posted (Estimated)
May 25, 2016
Study Record Updates
Last Update Posted (Estimated)
September 30, 2025
Last Update Submitted That Met QC Criteria
September 24, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001-CLJ-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.