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

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ClinicalTrials.gov Identifier: NCT02781922
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Japan Regenerative Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 19, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date November 17, 2020
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
Change in ejection fraction (EF(%)) assessed by MRI from baseline [ Time Frame: Baseline, 6 and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypoplastic Left Heart Syndrome
  • Single Ventricle
Intervention  ICMJE Genetic: Autologous cardiac stem cells (JRM-001)
3x 10^5 cells/kg, single treatment
Study Arms  ICMJE
  • Experimental: Autologous cardiac stem cells (JRM-001)
    Intervention: Genetic: Autologous cardiac stem cells (JRM-001)
  • No Intervention: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02781922
Other Study ID Numbers  ICMJE 001-CLJ-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Japan Regenerative Medicine Co., Ltd.
Study Sponsor  ICMJE Japan Regenerative Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Japan Regenerative Medicine Co., Ltd.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP