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

Primary Purpose

Dilated Cardiomyopathy

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
CDC infusion
Sponsored by
Okayama University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dilated Cardiomyopathy

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Okayama University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CDC infusion

Arm Description

CDCs infusion by coronary intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Ejection Fraction
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.

Full Information

First Posted
April 14, 2017
Last Updated
November 23, 2021
Sponsor
Okayama University
Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT03129568
Brief Title
Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy
Acronym
TICAP-DCM
Official Title
A Prospective Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okayama University
Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Transcoronary infusion
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDC infusion
Arm Type
Experimental
Arm Description
CDCs infusion by coronary intervention.
Intervention Type
Biological
Intervention Name(s)
CDC infusion
Intervention Description
Injection of CDCs (0.3 million per kg of body weight).
Primary Outcome Measure Information:
Title
Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs.
Description
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.
Time Frame
6 months after CDC treatment
Secondary Outcome Measure Information:
Title
Change in Ejection Fraction
Description
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.
Time Frame
6 months after protocol treatment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Uemura, M.D., Ph.D.
Organizational Affiliation
Shonan Tobu Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28052915
Citation
Ishigami S, Ohtsuki S, Eitoku T, Ousaka D, Kondo M, Kurita Y, Hirai K, Fukushima Y, Baba K, Goto T, Horio N, Kobayashi J, Kuroko Y, Kotani Y, Arai S, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary Cardiac Progenitor Cells in Single Ventricle Physiology: The PERSEUS (Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease) Randomized Phase 2 Trial. Circ Res. 2017 Mar 31;120(7):1162-1173. doi: 10.1161/CIRCRESAHA.116.310253. Epub 2017 Jan 4.
Results Reference
background
PubMed Identifier
26232942
Citation
Tarui S, Ishigami S, Ousaka D, Kasahara S, Ohtsuki S, Sano S, Oh H. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1198-1207, 1208.e1-2. doi: 10.1016/j.jtcvs.2015.06.076. Epub 2015 Jul 8.
Results Reference
background
PubMed Identifier
25403163
Citation
Ishigami S, Ohtsuki S, Tarui S, Ousaka D, Eitoku T, Kondo M, Okuyama M, Kobayashi J, Baba K, Arai S, Kawabata T, Yoshizumi K, Tateishi A, Kuroko Y, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Circ Res. 2015 Feb 13;116(4):653-64. doi: 10.1161/CIRCRESAHA.116.304671. Epub 2014 Nov 17.
Results Reference
background
PubMed Identifier
33298561
Citation
Hirai K, Ousaka D, Fukushima Y, Kondo M, Eitoku T, Shigemitsu Y, Hara M, Baba K, Iwasaki T, Kasahara S, Ohtsuki S, Oh H. Cardiosphere-derived exosomal microRNAs for myocardial repair in pediatric dilated cardiomyopathy. Sci Transl Med. 2020 Dec 9;12(573):eabb3336. doi: 10.1126/scitranslmed.abb3336.
Results Reference
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Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

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