Actively Recruiting
Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients
Led by Ever Supreme Bio Technology Co., Ltd. · Updated on 2024-09-19
41
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 20 to less than 76 years old at consent
- Presence of typical ischemic chest pain within 12 hours after symptom onset and clinical diagnosis of acute STEMI
- Underwent standard STEMI care including primary PCI, aspiration thrombectomy, and antithrombotic therapy within 12 hours of symptoms
- Successful acute reperfusion therapy with intracoronary stent placement and patent infarct-related artery suitable for cell infusion
- Left ventricular ejection fraction (LVEF) between 30% and less than 50% confirmed by echocardiogram
- Stable vital signs before UMSC01 infusion: no significant abnormal respiration, afebrile, systolic blood pressure 90-160 mmHg, heart rate 50-110/min
- Adequate pulmonary function: FEV1 over 50% predicted and oxygen saturation at least 95% on room air
- Adequate blood function: platelets at least 100,000/µL, hemoglobin at least 8 g/dL, PT and APTT no more than 1.5 times upper normal limit
- Signed informed consent
- Use of approved contraception methods for males and females with child-bearing potential for at least 1 year after last treatment
You will not qualify if you...
- Cardiogenic shock requiring vasopressors, intra-aortic balloon pump, or extracorporeal membrane oxygenation
- Severe aortic or mitral valve stenosis or regurgitation as per 2020 guidelines
- Need for staged coronary intervention or coronary artery bypass surgery
- Immunocompromised status, significant autoimmune disease, or immunosuppressive treatment within 12 weeks prior
- Active malignancy requiring treatment within 2 years prior
- Serious medical or psychiatric conditions in past 2 years that could interfere with study or safety
- Poor liver or kidney function after STEMI onset (AST or ALT ≥ 4 times normal; eGFR < 40 mL/min)
- Uncontrolled diabetes (blood glucose > 200 mg/dL or HbA1c ≥ 8.5%)
- Participation in another investigational trial within 3 months
- Known or suspected allergy to study product ingredients
- Pregnant, lactating, or positive pregnancy test in females with child-bearing potential
- Judged unsuitable for trial participation by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
Research Team
S
Sammi Hsu
CONTACT
J
Jack Tsai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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