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: NCT02568956
• Other study ID #: UCMSC-2
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 1, 2015
• Last updated: October 5, 2015
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2015
• Source: Academy Military Medical Science, China
• 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: 100
• 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:

• Age under 70;

• Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy

• New York Heart Association (NYHA) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%;

• No infection diseases including hepatitis B virus (HBV), hepatitis C virus(HCV), syphilis and AIDS;

• No psychiatric illnesses and speaking dysfunction;

• Informed consent.

Exclusion Criteria:

• More than 70 years old;

• LVEF<24%;

• Unstable hemodynamics, shock;

• Severe infection;

• Patients have tumor or other lethal diseases (expectation of life<6 months);

• Radiation patients;

• hematopoietic malignancy including Haemophiliacs;

• Anemia (Hb<100g/L);

• The other clinical trial participants within one month;

• Abnormal increasing of the blood biochemical indicators that is not explained by the conditions;

• Informed refusal.

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
Academy Military Medical Science, China	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 infarct size within the infarcted region measured by emission computed tomography (ECT)		6 month, 12 month,18 month	No
Primary	Change in myocardial viability within the infarcted region measured by emission computed tomography (ECT)		6 month, 12 month,18 month	No
Primary	Change in global left ventricular ejection fraction (LVEF)measured by echocardiography		6 month, 12 month,18 month	No
Secondary	Occurrence of major adverse cardiac event		6 month, 12 month,18 month	Yes