Acute Myocardial InfarctionMiSaver®NCT06353958
MiSaver® Stem Cell Treatment for Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Honya Medical Inc at 1 site in Taiwan.
Trial summary
Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. Read more about this study
- Who is it for?
- Ages 41 to 85 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- MiSaver
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- 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 41 to 85 years
- All sexes
- Adult, Older adult
Study population: Control group were retrospectively data retried from the study site, comprising 20 eligible participants meeting similar inclusion criteria for recent AMI and left ventricular ejection fraction (LVEF) < 45% was compared for analysis with the low and middle dosage groups.
Who may be able to join
- Patients aged between 20 and 80 years
- Diagnosed with AMI within 7 days
- Elevated cardiac enzymes (Creatine Kinase-MB or troponin) greater than 2 times the upper limit of normal
- Presence of regional wall motion abnormality
- LVEF ≤ 45% on echocardiography
- Hemodynamically stable
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- Not requiring inotropic support
- Systolic blood pressure below 80mm Hg for less than 1 hour
- Resting heart rate above 100 beats/min for less than 1 hour in the past 24 hours
- Peripheral artery oxygen saturation of ≥97%
Who cannot join
- Pregnancy or breastfeeding
- Positive adventitious infections (such as HIV, hepatitis)
- Need for coronary artery bypass surgery or anticipated further revascularization procedures during the 6-month study period
- Severe aortic or mitral valve narrowing
- Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
- Inability to receive PCI examination or treatment (including New York Heart Association (NYHA) Fc.IV) due to shortness of breath
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- Malignant tumor
- Hematopoietic dysplasia
- Other severe organ disease
- Less than 1 year of life expectancy
- Chronic kidney disease with estimated Glomerular Filtration Rate (eGFR)<20 and/or on renal dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Phase IIa Study of Intravenous Allogeneic Non-HLA-Matched, Unrelated Donor Stem Cell, MiSaver (Myocardial Infarction Saver), Infusion for Recent Acute Myocardial Infarction
Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.
Primary Endpoint:
Read more
The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.
Secondary Outcomes:
Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups.
Read the detailed description
Cardiovascular diseases, particularly acute myocardial infarction (AMI), persist as significant health concerns despite advancements in pharmaceutical and interventional treatments. Herein,investigators hypothesized stem cells could enhance left ventricular functional outcomes in patients recently afflicted by acute myocardial infarction (AMI). To investigate this hypothesis, investigators initiated an open-label, dose-escalating trial to evaluate the safety and feasibility of intravenous infusion of ABO matched allogeneic umbilical cord blood stem cells (USC), prefabricated into our study product MiSaver (Myocardial Infarction Functional Saver), in patients following recent AMI. Participants were enrolled in cohorts of five, each receiving low or middle dosages (0.5x10^7 and 1.6x10^7 cells/kg, respectively), with infusions administered 2-5 days post-AMI onset.
(Study details for low and middle dose please see study NCT04050163)
Retrospective participants meeting similar inclusion criteria of recent AMI and LVEF < 45% were identified from the study site. Twenty eligible participants were selected as controls and compared for analysis with the low and middle dosage groups.
- Conditions
- Acute Myocardial Infarction
- Being tested
- MiSaver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiSaverDrug
MiSaver vials was thawed using a thermostat-controlled mini bath, drawn into a 20ml syringe, and diluted with normal saline and intravenous infused following standard operating procedures, consecutively, until reasching the dosage.
Patients were premedicated with intravenous antihistamines (such as diphenhydramine) and corticosteroids (such as hydrocortisone) 30-60 minutes before the stem cell infusion. Any unused solution was discarded, and the total volume of injected solution was adjusted to accommodate the total daily fluid volume administered.
| Study group | Role | What they receive |
|---|---|---|
| Low | Low dosage of MiSaver cells at 0.5x10^7 cells/kg Receives: Drug: MiSaver | |
| Middle | Middle dosage of MiSaver cells at 1.6x10^7 cells/kg Receives: Drug: MiSaver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events events
The primary endpoint focused on safety evaluation and is measure with number of adverse events (AEs) over a 12-month observational period.
Measured: 12 months
Secondary outcomes (1)
Efficacy on ventricular ejection fraction (LVEF) improvement
Changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Honya Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chung Shan Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353958
- Sponsor's protocol ID
- MiSaver PIIa
- Acronym
- MiSaver®
- Status last verified
- Oct 2024
- First submitted
- 27 Mar 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Phase IIa Study of Intravenous Allogeneic Non-HLA-Matched, Unrelated Donor Stem Cell, MiSaver (Myocardial Infarction Saver), Infusion for Recent Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06353958
- Acronym / sponsor ID
- MiSaver® / MiSaver PIIa
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Honya Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Chung Shan Medical University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.
Primary Endpoint:
The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.
Secondary Outcomes:
Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups.
Detailed description
Cardiovascular diseases, particularly acute myocardial infarction (AMI), persist as significant health concerns despite advancements in pharmaceutical and interventional treatments. Herein,investigators hypothesized stem cells could enhance left ventricular functional outcomes in patients recently afflicted by acute myocardial infarction (AMI). To investigate this hypothesis, investigators initiated an open-label, dose-escalating trial to evaluate the safety and feasibility of intravenous infusion of ABO matched allogeneic umbilical cord blood stem cells (USC), prefabricated into our study product MiSaver (Myocardial Infarction Functional Saver), in patients following recent AMI. Participants were enrolled in cohorts of five, each receiving low or middle dosages (0.5x10^7 and 1.6x10^7 cells/kg, respectively), with infusions administered 2-5 days post-AMI onset.
(Study details for low and middle dose please see study NCT04050163)
Retrospective participants meeting similar inclusion criteria of recent AMI and LVEF < 45% were identified from the study site. Twenty eligible participants were selected as controls and compared for analysis with the low and middle dosage groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low | – | Drug: MiSaverLow dosage of MiSaver cells at 0.5x10^7 cells/kg |
| Middle | – | Drug: MiSaverMiddle dosage of MiSaver cells at 1.6x10^7 cells/kg |
Who may qualify
- Ages
- 41 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Control group were retrospectively data retried from the study site, comprising 20 eligible participants meeting similar inclusion criteria for recent AMI and left ventricular ejection fraction (LVEF) < 45% was compared for analysis with the low and middle dosage groups.
Key inclusion criteria (10 listed)
- Patients aged between 20 and 80 years
- Diagnosed with AMI within 7 days
- Elevated cardiac enzymes (Creatine Kinase-MB or troponin) greater than 2 times the upper limit of normal
- Presence of regional wall motion abnormality
- LVEF ≤ 45% on echocardiography
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding
- Positive adventitious infections (such as HIV, hepatitis)
- Need for coronary artery bypass surgery or anticipated further revascularization procedures during the 6-month study period
- Severe aortic or mitral valve narrowing
- Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiSaverMiSaver vials was thawed using a thermostat-controlled mini bath, drawn into a 20ml syringe, and diluted with normal saline and intravenous infused following standard operating procedures, consecutively, until reasching the dosage. Patients were premedicated with intravenous antihistamines (such as diphenhydramine) and corticosteroids (such as hydrocortisone) 30-60 minutes before the stem cell infusion. Any unused solution was discarded, and the total volume of injected solution was adjusted to accommodate the total daily fluid volume administered. | Drug | Low, Middle |
Primary outcome
Safety and adverse events events
Time frame: 12 months
The primary endpoint focused on safety evaluation and is measure with number of adverse events (AEs) over a 12-month observational period.
1 secondary outcome
Efficacy on ventricular ejection fraction (LVEF) improvement
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Honya Medical Inc at 1 site 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 11 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 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Safety and adverse events 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?
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 4 Oct 2024.