MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease (MCRcI®)

March 29, 2024 updated by: Honya Medical Inc

Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease

Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with Diffuse Coronary Artery Disease
  • Age 20~80
  • Participants have received proper medication
  • Canadian Cardiovascular Society class II- IV Angina.

Exclusion Criteria:

  • Age <20 or >80
  • Pregnant or breast feeding
  • Positive adventitious infection (such as HIV, hepatitis )
  • History of Myocardial Infarction within past 3 months
  • Severe aortic or mitral valve narrowing
  • Short of breath unable to receive PCI examination or treatment
  • Malignant tumor
  • Hematopoietic dysplasia
  • Severe organ disease with less than 1 year of life expectancy
  • Chronic kidney disease with CCr<20ml/min
  • Kiney disease on renal dialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose
Low Dose of MCRcI® stem cells.
Biological: MCRcI® stem cells
Intra-Coronary Administration of MCRcI® stem cells
Other Names:
  • stem cells
Experimental: Intermediate Dose
Intermediate Dose of MCRcI® stem cells.
Biological: MCRcI® stem cells
Intra-Coronary Administration of MCRcI® stem cells
Other Names:
  • stem cells
Experimental: High Dose
High Dose of MCRcI® stem cells.
Biological: MCRcI® stem cells
Intra-Coronary Administration of MCRcI® stem cells
Other Names:
  • stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events
Time Frame: 6 months
Number of adverse events
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricle stroke volume
Time Frame: 12 months
Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).
12 months
End diastolic volume
Time Frame: 12 months
Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml)
12 months
Left ventricular ejection fraction (LVEF)
Time Frame: 12 months
Calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).
12 months
Severity of angina symptom using Canadian Cardiovascular Society grading.
Time Frame: 12 months
Canadian Cardiovascular Society grading of angina pectoris is a classification system used to grade the severity of exertional angina. Scale ranges 0 ~ IV (most sever), with 0 Asymptomatic Angina, I Angina only with strenuous exertion, II Angina with moderate exertion, III Angina with mild exertion and IV Angina at rest.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Honya Medical Inc

Collaborators

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Fang Y Lee, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCG17121910001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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