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

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02666391
• Other study ID #: UCMSC-2
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 21, 2016
• Last updated: January 24, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: South China Research Center for Stem Cell and Regenerative Medicine
• Contact: Xuetao Pei, M.D., Ph.D
• Phone: 8610-68164807
• Email: AMMS0906[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiomyopathies
• Infarction
• Ischemic Cardiomyopathy
• Myocardial Infarction

Intervention

Biological:
• umbilical cord mesenchymal stem cells

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
South China Research Center for Stem Cell and Regenerative Medicine	Sun Yat-sen University

References & Publications (1)

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 da Q, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.		1 week, 6 month, 12 month,18 month	No
Primary	Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).		1 week, 18 month	No
Secondary	Pump failure Killip classification		baseline, 1 week, 1 month, 6 month, 12 month,18 month	No
Secondary	New York Heart Association(NYHA) classification		1 week, 1 month, 6 month, 12 month,18 month	No
Secondary	Occurrence of major adverse event		3 day, 1 week, 1 month, 6 month, 12 month,18 month	Yes