Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

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Brief Title

Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

Official Title

A Randomized Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy

Brief Summary

      A phase 1 randomized-controlled study to determine the procedural feasibility and safety and
      preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in
      patients with dilated cardiomyopathy.
    

Detailed Description

      This trial consists of 2 studies. Seven consecutive patients will be enrolled to a phase 1a
      study to verify the procedural feasibility and safety, followed by a phase 1b study to
      randomly assign 24 patients in a 1:1 ratio to the CDC infusion group and the control arm.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of Participants with Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs.

Secondary Outcome

 Change in Ejection Fraction

Condition

Dilated Cardiomyopathy

Intervention

CDC infusion

Study Arms / Comparison Groups

 CDC infusion
Description:  CDCs infusion by coronary intervention.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

31

Start Date

April 14, 2017

Completion Date

March 31, 2023

Primary Completion Date

March 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients diagnosed as dilated cardiomyopathy.

          -  Patients aged under 18 years old.

          -  Cardiac ejection fraction < 40%.

        Exclusion Criteria:

          -  Contradiction to cardiac magnetic resonance imaging.

          -  Cardiogenic shock.

          -  A patient with unstoppable extracorporeal circulation.

          -  A patient with lethal, uncontrollable arrhythmia.

          -  A patient with a complication of coronary artery disease.

          -  A patient with a complication of brain dysfunction due to circulatory failure.

          -  A patient with malignant neoplasm.

          -  A patient with a complication of a serious neurologic disorder.

          -  A patient with high-grade pulmonary embolism or pulmonary hypertension.

          -  A patient with high-grade renal failure.

          -  A patient with multiple organ failure.

          -  Active infection (including endocarditis).

          -  Sepsis.

          -  Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).
      

Gender

All

Ages

N/A - 17 Years

Accepts Healthy Volunteers

No

Contacts

Shigeru Uemura, M.D., Ph.D., , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT03129568

Organization ID

01F1701003


Responsible Party

Principal Investigator

Study Sponsor

Okayama University

Collaborators

 Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Sponsor

Shigeru Uemura, M.D., Ph.D., Study Chair, Shonan Tobu Clinic


Verification Date

March 2020