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

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
MCRcI® stem cells
Sponsored by
Honya Medical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HONYA Medical Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Dose

Intermediate Dose

High Dose

Arm Description

Low Dose of MCRcI® stem cells.

Intermediate Dose of MCRcI® stem cells.

High Dose of MCRcI® stem cells.

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events
Number of adverse events

Secondary Outcome Measures

Left ventricle stroke volume
Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).
End diastolic volume
Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml)
Left ventricular ejection fraction (LVEF)
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).
Severity of angina symptom using Canadian Cardiovascular Society grading.
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.

Full Information

First Posted
August 6, 2019
Last Updated
October 6, 2023
Sponsor
Honya Medical Inc
Collaborators
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04052191
Brief Title
MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease
Acronym
MCRcI®
Official Title
Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Honya Medical Inc
Collaborators
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation.
Masking
Participant
Masking Description
Participant blind with dose.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Low Dose of MCRcI® stem cells.
Arm Title
Intermediate Dose
Arm Type
Experimental
Arm Description
Intermediate Dose of MCRcI® stem cells.
Arm Title
High Dose
Arm Type
Experimental
Arm Description
High Dose of MCRcI® stem cells.
Intervention Type
Biological
Intervention Name(s)
MCRcI® stem cells
Other Intervention Name(s)
stem cells
Intervention Description
Intra-Coronary Administration of MCRcI® stem cells
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events
Description
Number of adverse events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Left ventricle stroke volume
Description
Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).
Time Frame
12 months
Title
End diastolic volume
Description
Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml)
Time Frame
12 months
Title
Left ventricular ejection fraction (LVEF)
Description
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).
Time Frame
12 months
Title
Severity of angina symptom using Canadian Cardiovascular Society grading.
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jackson TK Liu, MD
Phone
+886921167980
Email
honyamedical@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Y Lee, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HONYA Medical Inc
City
Tainan
ZIP/Postal Code
74147
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson TK Liu, MD
Phone
+88665055006
Email
info@honyamedical.com

12. IPD Sharing Statement

Plan to Share IPD
No

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MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

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