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

South China Research Center for Stem Cell and Regenerative Medicine

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Myocardial Infarction

Acute Myocardial Infarction

Ischemic Cardiomyopathy

Treatments

Biological: umbilical cord mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02666391

UCMSC-2

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.