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MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction) (MiSaver®)

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ClinicalTrials.gov Identifier: NCT04050163
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
Chung Shan Medical University
Information provided by (Responsible Party):
Honya Medical Inc

Brief Summary:
The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)

Condition or disease Intervention/treatment Phase
Myocardial Infarction Biological: MiSaver® Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential dose escalating
Masking: Single (Participant)
Masking Description: Single/participant blinded
Primary Purpose: Treatment
Official Title: Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction.
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

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Low Dose Biological: MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Other Name: stem cells

Experimental: Intermediate Dose Biological: MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Other Name: stem cells

Experimental: High Dose Biological: MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
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 (cc)

  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. Participants Physical Activity [ Time Frame: 12 months ]

    The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses.

    Scale ranges 0~100 (higer score better ), 100 Normal no complaints, 90 Able to carry on normal activity, 80 Normal activity with effort, 70 Cares for self but unable to carry on normal activity, 60 Requires occasional assistance, but is able to care for most of his personal needs, 50 Requires considerable assistance and frequent medical care, 40 Disabled and requires special care and assistance, 30 Severely disabled and hospital admission is indicated, 20 Very sick and hospital admission necessary, 10 Requires institutional or hospital care, 0 No life sign.




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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 aged 20~80
  • Acute Myocardial Infarction 1 to 10 days
  • Cardiac enzyme CK-MB or Troponin > 2X of high-end normal value
  • ST-elevation on EKG (STEMI)
  • Presence of regional wall motion abnormality
  • Left ventricular ejection fraction (LVEF) of ≤40%
  • Hemodynamically stable past 24 hour
  • Participants with adequate pulmonary function
  • Peripheral artery oxygen saturation ≥97%
  • Karnofsky performance status scores of ≥60.

Exclusion Criteria:

  • Age <20 or >80
  • Pregnant or breast feeding
  • Positive adventitious infections (such as HIV, hepatitis )
  • Revascularization via coronary artery bypass surgery is required
  • Coronary revascularization procedures is anticipated during the 6-month study period
  • Severe aortic or mitral valve narrowing
  • Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
  • 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
  • Kidney 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): NCT04050163


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

Locations
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Taiwan
Chung Shan Medical University Hospital Recruiting
Taichung, Taichung City, Taiwan, 402
Contact: GC Ueng, MD    +886424739595 ext 34116      
Principal Investigator: GC Ueng, MD         
HONYA Medical Inc Recruiting
Tainan, Taiwan, 74147
Contact: Jackson TK Liu, MD    +88665055006    info@honyamedical.com   
Sponsors and Collaborators
Honya Medical Inc
Chung Shan Medical University

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Responsible Party: Honya Medical Inc
ClinicalTrials.gov Identifier: NCT04050163     History of Changes
Other Study ID Numbers: csho19052112001
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 12, 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
Keywords provided by Honya Medical Inc:
Heart Attack
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases