Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration

NCT ID: NCT03351400

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2022-03-31

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.

Conditions

Chronic Heart Failure; Old Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Stem cells administered to participants

Group Type: EXPERIMENTAL

Stem cells administered to participants

Intervention Type: BIOLOGICAL

Patients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells.

Interventions

Stem cells administered to participants

Patients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CellBank of Japan

UNKNOWN

Sponsor Role: collaborator

Sakakibara Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sakakibara Heart Institute

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 22965994 (View on PubMed)

Other Identifiers

PB3170012

Identifier Type: -

Identifier Source: org_study_id