Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

— TICAP-DCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129568
• Other study ID #: 01F1701003
• Status: Completed
• Phase: Phase 1
• Start date: April 14, 2017
• Est. completion date: December 9, 2020

Study information

• Verified date: November 2021
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 9, 2020
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Biological:
• CDC infusion
Injection of CDCs (0.3 million per kg of body weight).

Locations

Country	Name	City	State
Japan	Okayama University Hospital	Okayama

Sponsors (2)

Lead Sponsor	Collaborator
Okayama University	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (4)

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). — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after CDC treatment
Secondary	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.	6 months after protocol treatment