MiSaver® Stem Cell Treatment for Acute Myocardial Infarction

NCT06353958 | Completed

• 1 other identifier: MiSaver PIIa
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Efficacy on ventricular ejection fraction (LVEF) improvement

  12 months

Study Arms (2)

Low

Low dosage of MiSaver cells at 0.5x10\^7 cells/kg

Drug: MiSaver

Middle

Middle dosage of MiSaver cells at 1.6x10\^7 cells/kg

Drug: MiSaver

Interventions

MiSaver DRUG

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.

Low; Middle

Eligibility Criteria

• Age: 41 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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%

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Honya Medical Inc: lead
• Chung Shan Medical University: collaborator

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 9, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

TW (1)