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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 : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Japan Regenerative Medicine Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Hypoplastic Left Heart Syndrome Single Ventricle Genetic: Autologous cardiac stem cells (JRM-001) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Autologous cardiac stem cells (JRM-001) Genetic: Autologous cardiac stem cells (JRM-001)
3x 10^5 cells/kg, single treatment

No Intervention: Usual care



Primary Outcome Measures :
  1. Change in ejection fraction (EF(%)) assessed by MRI from baseline [ Time Frame: Baseline, 6 and 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781922


Locations
Japan
Kanagawa Children's Medical Center Recruiting
Yokohama, Kanagawa, Japan
Contact: Hideaki Ueda, M.D.    +81-45-711-2351      
Principal Investigator: Hideaki Ueda, M.D.         
Okayama University Recruiting
Okayama, Japan
Contact: Shin-ichi Ohtsuki, M.D., Ph.D    +81-86-223-7151      
Principal Investigator: Shin-ichi Ohtsuki, M.D., Ph.D         
Shizuoka Children's Hospital Recruiting
Shizuoka, Japan
Contact: Kisaburo Sakamoto, M.D.    +81-54-247-6251      
Principal Investigator: Kisaburo Sakamoto, M.D.         
Sponsors and Collaborators
Japan Regenerative Medicine Co., Ltd.

Publications:
Responsible Party: Japan Regenerative Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02781922     History of Changes
Other Study ID Numbers: 001-CLJ-001
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Japan Regenerative Medicine Co., Ltd.:
cardiac stem/progenitor cells
autologous cell therapy
functional single ventricle
congenital heart disease

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities