Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy (TICAP-DCM)

November 23, 2021 updated by: Hidemasa Oh, MD, Okayama University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Japan
      • Okayama, Japan, 700-8558
        • Okayama University 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

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CDC infusion
CDCs infusion by coronary intervention.
Biological: CDC infusion
Injection of CDCs (0.3 million per kg of body weight).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs.
Time Frame: 6 months after CDC treatment
Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.
6 months after CDC treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ejection Fraction
Time Frame: 6 months after protocol treatment
To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants from baseline to 6 months of follow up.
6 months after protocol treatment

Collaborators and Investigators

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

Sponsor

Okayama University

Collaborators

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

Investigators

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

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 (Actual)

April 14, 2017

Primary Completion (Actual)

September 17, 2018

Study Completion (Actual)

December 9, 2020

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 23, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01F1701003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Dilated Cardiomyopathy

Clinical Trials on CDC infusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe