MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

Honya Medical

Status and phase: Begins enrollment in a year or more; Phase 1

Conditions: Coronary Artery Disease

Treatments: Biological: MCRcI® stem cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04052191

KCG17121910001

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Low Dose

Experimental group

Description:

Low Dose of MCRcI® stem cells.

Treatment:

Biological: MCRcI® stem cells

Intermediate Dose

Experimental group

Description:

Intermediate Dose of MCRcI® stem cells.

Treatment:

Biological: MCRcI® stem cells

High Dose

Experimental group

Description:

High Dose of MCRcI® stem cells.

Treatment:

Biological: MCRcI® stem cells