Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration

Chronic Heart Failure Clinical Trial

— JOKER  

Official title:

Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03351400
• Other study ID #: PB3170012
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 15, 2017
• Est. completion date: March 2022

Study information

• Verified date: March 2021
• Source: Sakakibara Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.

Description:

This phase I trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. This study will be conducted as a collaborative project between the Sakakibara Heart Institute and the CellBank of Japan. The trial is designed to assess the safety and effectiveness of autologous administration of 1,000,000 c-kit-positive cardiac stem cells (CSCs) via intracoronary route following cultivation. The preliminary eligibility criteria will utilize a left ventricular ejection fraction (LVEF) less than 40% measured by echocardiography. During the coronary artery bypass grafting (CABG) surgery, a part (less than 1 gram) of the right atrial appendage (RAA) will be harvested and frozen. When the LVEF is less than 40% after the CABG surgery, the subject will be enrolled as a candidate for the delivery of CSCs, which will be selected from the RAA tissue and cultured for a few months for expansion. The outcome will be evaluated by adverse events as well as cardiac functions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adult with ability to provide informed consent.
• Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
• Scheduled for elective surgical revascularization within 2 months.

Exclusion Criteria:

• Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
• Diabetic HbA1c greater than 8.5%.
• Pregnant women.
• Scheduled for additional interventions including ventriculoplasty.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Infarction
• Myocardial Infarction
• Old Myocardial Infarction

Intervention

Biological:
• Stem cells administered to participants
Patients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells.

Locations

Country	Name	City	State
Japan	Sakakibara Heart Institute	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Sakakibara Heart Institute	CellBank of Japan

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Chugh AR, Beache GM, Loughran JH, Mewton N, Elmore JB, Kajstura J, Pappas P, Tatooles A, Stoddard MF, Lima JA, Slaughter MS, Anversa P, Bolli R. Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance. Circulation. 2012 Sep 11;126(11 Suppl 1):S54-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring adverse events	Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism	2 years
Secondary	NYHA classification	Measurement of symptom	2 years
Secondary	Serum NT-proBNP	Measurement of cardiac function	2 years
Secondary	Electrocardiogram	Measurement of arrhythmia	2 years
Secondary	Chest X-ray	Measurement of cardiac function	2 years
Secondary	Cardiopulmonary exercise test	Measurement of cardiopulmonary function	2 years
Secondary	Echocardiogram	Measurement of cardiac function	2 years
Secondary	Magnetic resonance imaging	Measurement of cardiac function	2 years
Secondary	Myocardial scintigraphy	Measurement of myocardial viability	2 years