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Stem Cell Therapy

Autologous cardiac stem cells (JRM-001) for Hypoplastic Left Heart Syndrome (APOLLON Trial)

Phase 3
Recruiting
Research Sponsored by Japan Regenerative Medicine Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6 and 12 months
Awards & highlights

APOLLON 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

Eligible Conditions
  • Hypoplastic Left Heart Syndrome
  • Single Ventricle Heart

APOLLON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ejection fraction (EF(%)) assessed by MRI from baseline
Secondary outcome measures
Change in EF(%) assessed by cardiac catheterization from baseline
Change in EF(%) assessed by echocardiograms from baseline
Change in Ea/Ees assessed by cardiac catheterization from baseline
+4 more

APOLLON Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Autologous cardiac stem cells (JRM-001)Experimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Japan Regenerative Medicine Co., Ltd.Lead Sponsor
Metcela Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
2016. "Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02781922.
~4 spots leftby May 2025
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