Evaluate the Safety and Explore Efficacy of Umbilical Cord Mesenchymal Stem Cells in Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT04056819|
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Biological: Allogeneic umbilical cord mesenchymal stem cells||Phase 1|
Cardiovascular disease is the leading cause of death in the developed world, with global deaths due to coronary artery disease estimated to increase from 7.3 million in 2008 to 25 million by 2020 WHO, 2011.
The leading symptom that initiates the diagnostic and therapeutic cascade in patients with suspected acute coronary syndromes (ACS) is chest pain.
Most patients will ultimately develop an ST elevation myocardial infarction (STEMI). The mainstay of treatment in these patients is immediate reperfusion by primary angioplasty or fibrinolytic therapy. Basically, STEMI comprises approximately 25% to 40% of myocardial infarction (MI) presentations. Acute STEMI is a major cause of morbidity, mortality, and disability.
This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. For animal studies, UMSC01 has been demonstrated its effectiveness for AMI and stroke. The rats with coronary artery ligation receiving intravenous injection of UMSC01 showed significantly improved cardiac function.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open Label Study to Evaluate the Safety and to Explore Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With ST-elevation Acute Myocardial Infarction|
|Actual Study Start Date :||May 27, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||August 2021|
UMSC01 cells mixed with normal saline will be administered to patients after the onset of heart attack.
Biological: Allogeneic umbilical cord mesenchymal stem cells
UMSC01 cells will be one single IC infusion followed by one single IV infusion with 12 months of follow up after treatment.
- Incidence of Treatment emergent adverse event (TEAE) as presented by MedDRA coding system [ Time Frame: from visit 2 to 12-month follow-up period ]TEAE incidences over the study period
- Incidence of Serious adverse event (SAE) as presented by MedDRA coding system [ Time Frame: from visit 2 to 12-month follow-up period ]SAE incidences over the study period
- Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system [ Time Frame: from visit 2 to 12-month follow-up period ]SUSAR incidences over the study period
- New York Heart Association (NYHA) Classification [ Time Frame: 12 weeks ]The NYHA classification is used to grade the severity of functional limitations in a patient with heart failure with Class I=no limitations to Class IV=unable to carry on any physical activity without discomfort.
- Incidence of major adverse cardiovascular events (MACE) [ Time Frame: from screen visit to 12-month follow-up period ]MACE are defined as death, recurrent MI, stroke, target vessel revascularization.
- Serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP) [ Time Frame: 52 weeks ]Change of serum level of NT pro-BNP from baseline visit to subsequent visits will be summarized by descriptive statistics.
- Pulmonary function test [ Time Frame: 52 weeks ]The FEV1 will be tested by Spirometry and recorded.
- 12-lead ECG Test [ Time Frame: 52 weeks ]Echocardiography will be performed and evaluated by using standard methods of the American Society of Echocardiography. 12-lead ECG examinations will be performed at each visit to obtain PR, QRS, QT, QTc, and RR intervals.
- Cardiac MRI (cMRI) for baseline and efficacy evaluation [ Time Frame: 52 weeks ]Change of ventricular volume measured by left ventricular (LV) end diastolic volume and left ventricular ejection fraction (LVEF); infarct size quantified by delayed contrast enhanced cMRI; measure left ventricular remodeling with left ventricular end diastolic volume (LVEDV), which is the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole, and left ventricular end systolic volume (LVESV), which is the blood volume in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole from baseline visit to subsequent visits will be summarized by descriptive statistics.
- Cardiac Positron emission tomography (CPET) to demonstrate perfusion-metabolism mismatch [ Time Frame: 52 weeks ]CPET scans images in short-axis, vertical long-axis and horizontal long-axis will be obtained to demonstrate perfusion-metabolism mismatch in the mid and basal anterior, anteroseptal, anterolateral and lateral walls consistent with myocardial viability in those areas. Perfusion-metabolism matched defects measured as less than 50% of normal or maximum intensity of perfusion and metabolic radioactivity and perfusion-metabolism mismatch defects is less than 50% of normal or max intensity of perfusion radioactivity with more than or equal to 50% of normal or maximum intensity of metabolic radioactivity. The interpretation of CPET results will be provided by the investigators in narrative form.
- Tl-201 single photon emission computed tomography (SPECT) scan to determine myocardial infarction occurrence [ Time Frame: 52 weeks ]Tl-201 SPECT (Gamma camera: Discovery NM/CT 670 or GE/Infinia Hawkeye 4) will be performed before FDG PET/CT scan. Myocardial regions with radioactivity less than 50% of normal or maximum intensity of radioactivity of left ventricular myocardial wall will be regarded as myocardial infarction, or hibernating myocardium. The interpretation of SPECT results will be provided by the investigators in narrative form.
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): NCT04056819
|Contact: Sammi Hsu||886-4-2325-288 ext firstname.lastname@example.org|
|Contact: Woei C Shyuemail@example.com|
|China Medical University Hospital||Recruiting|
|Taichung, Non-US, Taiwan, 404|
|Contact: Sammi Hsu firstname.lastname@example.org|
|Principal Investigator: Lien C Hsiao, PhD|