Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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The study is designed to assess the safety and efficacy of allogeneic human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted into patients with chronic ischemic cardiomyopathy.

Official Title
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The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy

Conditions
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Chronic Ischemic Cardiomyopathy

Intervention / Treatment
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* Biological: hUC-MSCs+Injectable collagen scaffold+CABG
* Biological: hUC-MSCs+CABG
* Procedure: CABG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 35-65 years old. Chronic coronary artery disease with coronary Stenosis detectable by percutaneous coronary intervention (PCI). Ineligibility for percutaneous revascularization, as assessed by coronary arteriography. Ineligibility for percutaneous revascularization procedures was determined by 2 expert committees: a surgical committee comprising 2 cardiovascular surgeons and a noninvasive cardiologist, and an interventional committee comprising 2 interventional cardiologists and 1 noninvasive cardiologist. MRI confirmed that chronic coronary artery disease and ischemic regions. Left ventricular ejection fraction (LVEF)≤40%. NYHA Class II-IV. No organ dysfunction for lung, liver and kidney. Patients are able and willing to observe therapeutic effect and adverse events. Signed informed consent. Negative serum pregnancy test. No coagulation dysfunction. Glycated hemoglobin ≤6.5. Exclusion Criteria: Lactating or pregnant woman. Ineligibility for CABG. Unexplainable baseline laboratory abnormalities. Sensitivity to any of the study medications. Acute myocardial infarction within 1 months of enrollment in the study. Patients suffering cardiovascular disease, such as aortic disease, malignant arrhythmias, congenital heart disease, intracardiac mass, moderate or severe valvular stenosis or regurgitation. History of life threatening allergic or immune-mediated reaction. Systemic infection or severe local infection. Shock or MODS or patients cannot cooperate with doctors. Severe heart, lung, liver or renal dysfunction. Taking medicine that might have effect on outcomes assess. Suffering HIV, Hepatitis B or Hepatitis C. Participation in any clinical trial in recent three months. History of mental illness or suicide risk. High expectation or unrealistic demands. Recently suffered a lot of radiation exposure. Previous or current history of neoplasia or other comorbidity that could impact the patient's short-term survival. Patients with serious complications of coronary artery disease (e.g., perforation of interventricular septum and ventricular aneurysm and mitral regurgitation due to papillary muscle dysfunction). Abnormal coagulation function. Patients with hemodynamic instability which may lead to serious complications. Any condition that, in the judgment of the investigator, would place the patient at under risk.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hUC-MSCs+Injectable collagen scaffold+CABG<br> | Biological: hUC-MSCs+Injectable collagen scaffold+CABG<br>* Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) in collagen scaffold injecting in the infarct region.<br>|
| Active Comparator: hUC-MSCs+CABG<br> | Biological: hUC-MSCs+CABG<br>* Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region.<br>|
| Active Comparator: CABG<br> | Procedure: CABG<br>* Patients underwent CABG alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events | Adverse events (AEs), serious adverse events (SAEs) and changes in vital signs, electrocardiogram (ECG) and laboratory values were measured. | up to 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial blood flow | Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI). | 1, 3, 6, 12 and 24 months | 
| Left ventricle ejection fraction (LVEF) | Change in LVEF as measured by ultrasonic cardiogram (UCG) and Cardiac magnetic resonance imaging (MRI). | 1, 3, 6, 12 and 24 months | 
| Infarct size | Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI). | 1, 3, 6, 12 and 24 months | 
| New York Heart Association (NYHA) Functional Classification | Change in clinical symptoms evaluated by NYHA. | 1, 3, 6, 12 and 24 months | 
| Canadian Cardiovascular Society (CCS) Angina Grading Scale | Change in clinical symptoms evaluated by CCS. | 1, 3, 6, 12 and 24 months |