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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052191
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Honya Medical Inc

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Biological: MCRcI® stem cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation.
Masking: Single (Participant)
Masking Description: Participant blind with dose.
Primary Purpose: Treatment
Official Title: Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose
Low Dose of MCRcI® stem cells.
Biological: MCRcI® stem cells
Intra-Coronary Administration of MCRcI® stem cells
Other Name: stem cells

Experimental: Intermediate Dose
Intermediate Dose of MCRcI® stem cells.
Biological: MCRcI® stem cells
Intra-Coronary Administration of MCRcI® stem cells
Other Name: stem cells

Experimental: High Dose
High Dose of MCRcI® stem cells.
Biological: MCRcI® stem cells
Intra-Coronary Administration of MCRcI® stem cells
Other Name: stem cells




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events [ Time Frame: 6 months ]
    Number of adverse events


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052191


Contacts
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Contact: Jackson TK Liu, MD +886921167980 honyamedical@gmail.com

Locations
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Taiwan
HONYA Medical Inc Recruiting
Tainan, Taiwan, 74147
Contact: Jackson TK Liu, MD    +88665055006    info@honyamedical.com   
Sponsors and Collaborators
Honya Medical Inc
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Fang Y Lee, MD Chang Gung Memorial Hospital

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Responsible Party: Honya Medical Inc
ClinicalTrials.gov Identifier: NCT04052191     History of Changes
Other Study ID Numbers: KCG17121910001
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases