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Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration (JOKER)

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ClinicalTrials.gov Identifier: NCT03351400
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
CellBank of Japan
Information provided by (Responsible Party):
Sakakibara Heart Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Old Myocardial Infarction Biological: Stem cells administered to participants Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration Trial
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Treatment group
Stem cells administered to participants
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.




Primary Outcome Measures :
  1. Monitoring adverse events [ Time Frame: 2 years ]
    Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism


Secondary Outcome Measures :
  1. NYHA classification [ Time Frame: 2 years ]
    Measurement of symptom

  2. Serum NT-proBNP [ Time Frame: 2 years ]
    Measurement of cardiac function

  3. Electrocardiogram [ Time Frame: 2 years ]
    Measurement of arrhythmia

  4. Chest X-ray [ Time Frame: 2 years ]
    Measurement of cardiac function

  5. Cardiopulmonary exercise test [ Time Frame: 2 years ]
    Measurement of cardiopulmonary function

  6. Echocardiogram [ Time Frame: 2 years ]
    Measurement of cardiac function

  7. Magnetic resonance imaging [ Time Frame: 2 years ]
    Measurement of cardiac function

  8. Myocardial scintigraphy [ Time Frame: 2 years ]
    Measurement of myocardial viability



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351400


Contacts
Contact: Toru Hosoda, M.D., Ph.D. +81-42-314-3111 thosoda@shi.heart.or.jp
Contact: Hitonobu Tomoike, M.D., Ph.D. +81-42-314-3111 htomoike@shi.heart.or.jp

Locations
Japan
Sakakibara Heart Institute Recruiting
Tokyo, Japan, 183-0003
Contact: Toru Hosoda, M.D., Ph.D.    +81-42-314-3111    thosoda@shi.heart.or.jp   
Sponsors and Collaborators
Sakakibara Heart Institute
CellBank of Japan

Publications:
Responsible Party: Sakakibara Heart Institute
ClinicalTrials.gov Identifier: NCT03351400     History of Changes
Other Study ID Numbers: PB3170012
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sakakibara Heart Institute:
cardiac stem cells
c-kit

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases