Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)

Phase 1

• Conditions: Acute Myocardial Infarction; Myocardial Infarction; Ischemic Cardiomyopathy
• Interventions: Biological: umbilical cord mesenchymal stem cells

• Registration Number: NCT02666391
• Lead Sponsor: South China Research Center for Stem Cell and Regenerative Medicine

Brief Summary

The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-24
• Last Update Submitted: 2016-01-24
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28
• Study Start: 2016-05
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery;
• LVEF (left ventricular ejection fraction): 25-45%;
• Age between 18 and 70, borh gender;
• Women of childbearing age agreed to take contraceptive measures during the whole study period;
• No psychiatric illnesses and speaking dysfunction;
• Informed consent.

Exclusion Criteria

• Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF<24%;
• Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value;
• Patients suffered from severe arrhythmia;
• Patients suffered from stent thrombosis;
• Patients receiving immunosuppressive therapy;
• Patients have tumor or other lethal diseases (expectation of life<6 months);
• Women who plan to be pregnant or are pregnant or nursing;
• Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen);
• Other clinical trial participants within 3 months;
• Investigators judge other conditions not suitable for inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UCMSCs	umbilical cord mesenchymal stem cells	Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)

Primary Outcome Measures

Name	Time	Method
Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).	1 week, 18 month
Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.	1 week, 6 month, 12 month,18 month

Secondary Outcome Measures

Name	Time	Method
Pump failure Killip classification	baseline, 1 week, 1 month, 6 month, 12 month,18 month
New York Heart Association(NYHA) classification	1 week, 1 month, 6 month, 12 month,18 month
Occurrence of major adverse event	3 day, 1 week, 1 month, 6 month, 12 month,18 month