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