Trial | NCT03351400  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    6
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.
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 Started
Nov 15
2017
Primary Completion
Mar 31
2022
Anticipated
Study Completion
Mar 31
2022
Anticipated
Last Update
Mar 18
2021

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.

Treatment group Experimental

Stem cells administered to participants

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.
No Results Posted