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

September 28, 2022 updated by: Metcela Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Autologous cardiac stem cells (JRM-001)
Genetic: Autologous cardiac stem cells (JRM-001)
3x 10^5 cells/kg, single treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in ejection fraction (EF(%)) assessed by MRI from baseline
Time Frame: Baseline, 6 and 12 months
Baseline, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in EF(%) assessed by echocardiograms from baseline
Time Frame: Screening, Baseline, 3, 6 and 12 months
Screening, Baseline, 3, 6 and 12 months
Change in EF(%) assessed by cardiac catheterization from baseline
Time Frame: Baseline, 6 and 12 months
Baseline, 6 and 12 months
Change in Ea/Ees assessed by cardiac catheterization from baseline
Time Frame: Baseline, 6 and 12 months
Baseline, 6 and 12 months
Change in Ventricular Stiffness assessed by cardiac catheterization from baseline
Time Frame: Baseline, 6 and 12 months
Baseline, 6 and 12 months
Change in heart failure index from baseline
Time Frame: Baseline, 3, 6 and 12 months
Baseline, 3, 6 and 12 months
Change in Quality of Life (QOL) index from baseline
Time Frame: Baseline, 6 and 12 months
Baseline, 6 and 12 months
Number of adverse events
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metcela Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

May 20, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-CLJ-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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