Clinical trial NCT02666391: Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myocardial Infarction
Myocardial Infarction
Ischemic Cardiomyopathy
Lead sponsor: South China Research Center for Stem Cell and Regenerative Medicine
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2016-01-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.
timeFrame: 1 week, 6 month, 12 month,18 month
measure: Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).
timeFrame: 1 week, 18 month
Secondary outcomes:
measure: Pump failure Killip classification
timeFrame: baseline, 1 week, 1 month, 6 month, 12 month,18 month
measure: New York Heart Association(NYHA) classification
timeFrame: 1 week, 1 month, 6 month, 12 month,18 month
measure: Occurrence of major adverse event
timeFrame: 3 day, 1 week, 1 month, 6 month, 12 month,18 month
Other outcomes:
Locations:
Study officials:
References:
citation: Gao LR, Pei XT, Ding QA, Chen Y, Zhang NK, Chen HY, Wang ZG, Wang YF, Zhu ZM, Li TC, Liu HL, Tong ZC, Yang Y, Nan X, Guo F, Shen JL, Shen YH, Zhang JJ, Fei YX, Xu HT, Wang LH, Tian HT, Liu DQ, Yang Y. A critical challenge: dosage-related efficacy and acute complication intracoronary injection of autologous bone marrow mesenchymal stem cells in acute myocardial infarction. Int J Cardiol. 2013 Oct 9;168(4):3191-9. doi: 10.1016/j.ijcard.2013.04.112. Epub 2013 May 4.