Infusing a child's own heart stem cells during single-ventricle surgery (APOLLON)

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 a phase 3 interventional study testing intracoronary delivery of autologous cardiac stem/progenitor cells (JRM-001) given after reconstructive surgery in pediatric patients with a functional single ventricle. Eligible patients are those scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery with echocardiographic ejection fraction ≤55% and parental consent. The intervention uses each patient’s own harvested cardiac cells, expanded and infused into the coronary circulation, with follow-up to monitor heart function and safety outcomes. The trial is being conducted at multiple pediatric cardiac centers in Japan.

Why it matters

Who can join: the full rules

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

Where it's running

• Kanagawa Children's Medical Center
  Kanagawa, Japan Recruiting
• Okayama University Hospital
  Okayama, Japan Recruiting
• Osaka Women's and Children's Hospital
  Osaka, Japan Recruiting
• Shizuoka Children's Hospital
  Shizuoka, Japan Recruiting

Study contacts

• Study coordinator: Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.)
• Email: info@j-rm.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  This study checks whether autologous cardiac stem cells (JRM-001) remain safe for up to a year in children who already received them after heart reconstructive surgery.

  Recruiting Metcela Inc. · Okayama, Okayama-ken · NCT07884318

• Venous Compression for Fontan Patients

  This study tests whether wearing lower-extremity compression garments can increase exercise stroke volume in people with Fontan circulation.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT07220226

• Starting Fortini after the first heart surgery to help infants with single-ventricle defects grow better

  This trial will see if giving Fortini, a high-calorie low-osmolality formula, at hospital discharge helps infants with single-ventricle heart defects gain more weight before their next surgery.

  Recruiting Driscoll Children's Hospital · Corpus Christi, Texas · NCT07087782

• Fontan conduit stenting to lower liver stiffness and improve exercise capacity

  This project will see if placing a stent in an extracardiac Fontan conduit changes liver stiffness and exercise capacity in 12–21-year-olds with single-ventricle Fontan palliation.

  Recruiting Children's Hospital Los Angeles · Los Angeles, California · NCT07073612

• Evaluating the effectiveness of SGLT2 inhibitors in adults with congenital heart disease

  This study is trying to see if a new type of diabetes medication can help adults with congenital heart disease feel better and manage their heart failure symptoms.

  Recruiting at 11 sites Leiden University Medical Center · Baltimore, Maryland and 10 other locations · NCT06932081

• Improving fitness for adolescents with the Fontan circulation

  This study will test whether a home-based digital exercise program helps 10–17-year-olds with the Fontan circulation become more active and improve fitness compared with enhanced usual care.

  Recruiting Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT06918795

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.