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NCT Number: NCT02781922

Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)

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

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Key information

Conditions

Hypoplastic Left Heart Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Single Ventricle Univentricular Heart

Age range

0 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kanagawa Children's Medical Center, Kanagawa, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous cardiac stem cells (JRM-001)

Genetic

3x 10^5 cells/kg, single treatment

Primary outcomes

  1. Change in ejection fraction (EF(%)) assessed by MRI from baseline

    Time frame: Baseline, 6 and 12 months

Secondary outcomes

  1. Change in EF(%) assessed by echocardiograms from baseline

    Time frame: Screening, Baseline, 3, 6 and 12 months

  2. Change in EF(%) assessed by cardiac catheterization from baseline

    Time frame: Baseline, 6 and 12 months

  3. Change in Ea/Ees assessed by cardiac catheterization from baseline

    Time frame: Baseline, 6 and 12 months

  4. Change in Ventricular Stiffness assessed by cardiac catheterization from baseline

    Time frame: Baseline, 6 and 12 months

  5. Change in heart failure index from baseline

    Time frame: Baseline, 3, 6 and 12 months

  6. Change in Quality of Life (QOL) index from baseline

    Time frame: Baseline, 6 and 12 months

  7. Number of adverse events

    Time frame: Up to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.)

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Metcela Inc.

Industry

Registry information

Official study 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

Acronym: APOLLON

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
May 25, 2016
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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