Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.

Detailed Description
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Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study. Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention. Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects. The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months. Clinical results will be analyzed after completion of 12 months of followup.

Official Title
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Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy

Conditions
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Chronic Ischemic Heart Disease, Heart Failure, Angina

Intervention / Treatment
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* Biological: UCMSC group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 y No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist). Maximal tolerable angina and heart failure medication NYHA functional classification (I-III) Signed informed consent Exclusion Criteria: Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI. Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month. History with malignant disease within 5 y of inclusion or suspected malignity Severe heart failure (NYHA functional classification IV) Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment Patients with reduced immune response or treated with immunosuppressive medication Combined with severe infectious diseases Pregnant or fertile women Socially and mentally disabilities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCMSC group<br>Patients in this arm received umbilical cord MSCs by intracoronary injection | Biological: UCMSC group<br>* Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7)<br>|
| No Intervention: Control group<br>Patients in this arm did not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and nature of adverse events | Evidence for new clinical/biological abnormalities. | Within the first year after intracoronary infusion | 
| Incidence of major adverse coronary events (MACE) | Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure. | Within the first year after intracoronary infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Time and Level | Exercise time and level as assessed via six minute walk test. | Post cell transplantation: 1, 3, 6, 12 months | 
| Quantify myocardium perfusion measured by SPECT | The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT. | Post cell transplantation: 6, 12 months | 
| Assessment of heart function by left ventricular ejection fraction | Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation. | Post cell transplantation: 1, 3, 6，12 months | 
| Clinical Improvement in NYHA Classification | The NYHA scale ranges from 1 (best)Mild- no limitation of physical activity due to heart failure to 4 (worst) Severe-Unable to carry out any physical activity without discomfort due to heart failure. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cellular therapy, Chronic ischemic heart disease, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, ischemic heart disease, allogeneic stem cell transplantation