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NCT Number: NCT04052191

MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MCRcI® stem cells

Biological

Intra-Coronary Administration of MCRcI® stem cells

Other names: stem cells

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events

    Time frame: 6 months

    Number of adverse events

Secondary outcomes

  1. 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).

  2. End diastolic volume

    Time frame: 12 months

    Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml)

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jackson TK Liu, MD

CONTACT

[email protected]

+886921167980

Sponsors and collaborators

Lead sponsor

Honya Medical Inc

Industry

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

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

Acronym: MCRcI®

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2019
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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