A clinical study to determine the safety and effectiveness of intracoronary infusion of autologous c-kit-positive cardiac stem cells in Japanese patients with ischemic cardiomyopathy.

Japanese OMI treatment with Kit-positive cells for Enhanced Regeneration trial - JOKER trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb030200001

Enrollment

Registered

2020-03-31

Start date

2017-11-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic ischemic heart failure Heart Failure

Interventions

Autologous intracoronary single infusion of 1,000,000 cardiac stem cells via cardiac catheter.

Stem Cell Transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult with ability to provide informed consent. Left ventricular ejection fraction less than 40%. Scheduled for elective surgical revascularization within 2 months.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Frequency and severity of adverse events (death, ventricular arrhythmia, infection, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism, etc.) at 1, 3, 6, 9, 12, 15, 18, 21, 24 months after the cell infusion.	—

Secondary

Measure	Time frame
Symptom by NYHA classification, NT-proBNP, electrocardiogram, chest X-ray, cardiopulmonary exercise test, cardiac function by echocardiogram and magnetic resonance imaging, viability evaluation by myocardial scintigraphy.	—

Countries

Japan

Contacts

Public ContactHiromi Shinoki

Sakakibara Heart Institute

tiken@shi.heart.or.jp+81-42-314-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026