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Myocardial InfarctionPhase 1/2MiSaver®NCT04050163

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

A Phase 1/2 study testing MiSaver® in people with Myocardial Infarction, run by Honya Medical Inc at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Myocardial Infarction
What is being tested?
MiSaver®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesTaiwan
Study dates
26 Jan 2021to 4 May 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • Hemodynamically stable past 24 hour
  • Participants with adequate pulmonary function
  • Peripheral artery oxygen saturation ≥97%
  • Karnofsky performance status scores of ≥60.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Chung Shan Medical University Hospital

    Taichung, Taichung City, 402

  • HONYA Medical Inc

    Tainan, 74147

Other trials in Taiwan

About this study

Official title: Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.

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)

Being tested
MiSaver®
Keywords
Heart Attack
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiSaver®Biological

    Also called stem cells

    Intravenous administration of MiSaver® Stem Cell via peripheral vein access.

Study groups in NCT04050163
Study groupRoleWhat they receive
Low DoseExperimentalCells dosage, 0.5x10^7 cells/kg body weight
Receives: Biological: MiSaver®
Intermediate Dose (aka Effective or High)ExperimentalCells dosage, 1.6x10^7 cells/kg body weight
Receives: Biological: MiSaver®
Toxic DoseExperimentalCells dosage, 5.0 x10^7 cells/kg body weight
Receives: Biological: MiSaver®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment Emergent Adverse Events

    Number of Adverse Events

    Measured: 12 months

Secondary outcomes (5)

  1. Left ventricle stroke volume

    Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).

    Measured: 12 months

  2. End diastolic volume

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

    Measured: 12 months

  3. 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).

    Measured: 12 months

  4. Participants Functional Activity by NYHA Classification

    The New York Heart Association (NYHA) Functional Classification is a useful tool for classifying the extent of functional limitations in patients with heart conditions. The system categorizes patients into one of four categories based on the level of limitation they experience during physical activity, with symptoms ranging from mild shortness of breath or angina to more severe breathing difficulties. The NYHA classification focuses specifically on limitations related to physical activity and provides a straightforward approach to assessing a patient's condition. By using this system, healthcare providers can quickly and easily determine the level of functional limitation in their patients and tailor treatment plans accordingly.

    Measured: 12 months

  5. Participants Functional Activity by CCS Classification

    The Canadian Cardiovascular Society grading of angina pectoris, also known as the CCS Functional Classification, is a widely used clinical tool that classifies the severity of exertional angina. It allows doctors to assess the degree of angina severity in patients, and subsequently develop a tailored treatment plan. Although there are no definitive therapy guidelines specific to each class, healthcare providers can use the CCS grading system as a framework to guide treatment planning based on the severity of angina and other individual factors such as age and the risk of major cardiac complications. By utilizing the CCS grading system, healthcare providers can ensure that patients receive personalized treatment that addresses their unique needs and circumstances.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start26 Jan 2021
  3. Primary completion4 May 2023
  4. Study completion4 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Sequential dose escalating
Masking
Single blind
Who is masked
Participant
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050163
Sponsor's protocol ID
csho19052112001
Acronym
MiSaver®
Status last verified
Mar 2024
First submitted
6 Aug 2019
Last updated
29 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MiSaver® in people with Myocardial Infarction, run by Honya Medical Inc at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04050163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.

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