Clinical trial NCT03351400: Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration
Official title: Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Heart Failure
Old Myocardial Infarction
Keywords: cardiac stem cells
c-kit
Lead sponsor: Sakakibara Heart Institute
Sponsor class: OTHER
Collaborators: name: CellBank of Japan
First posted: 2017-11-22
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Monitoring adverse events
timeFrame: 2 years
Secondary outcomes:
measure: NYHA classification
timeFrame: 2 years
measure: Serum NT-proBNP
timeFrame: 2 years
measure: Electrocardiogram
timeFrame: 2 years
measure: Chest X-ray
timeFrame: 2 years
measure: Cardiopulmonary exercise test
timeFrame: 2 years
measure: Echocardiogram
timeFrame: 2 years
measure: Magnetic resonance imaging
timeFrame: 2 years
measure: Myocardial scintigraphy
timeFrame: 2 years
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sakakibara Heart Institute
Study officials:
References:
citation: 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. doi: 10.1161/CIRCULATIONAHA.112.092627.