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

NCT ID: NCT02666391

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Acute Myocardial Infarction; Myocardial Infarction; Ischemic Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UCMSCs

Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)

Group Type: EXPERIMENTAL

umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

controls

Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

South China Research Center for Stem Cell and Regenerative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xuetao Pei, M.D., Ph.D

Role: CONTACT

AMMS0906@163.com

8610-68164807

Junnian Zhou, Ph.D

Role: CONTACT

zhoujunnian@scrm.org.cn

8620-89199011

References

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.

Reference Type: BACKGROUND

PMID: 23651816 (View on PubMed)

Other Identifiers

UCMSC-2

Identifier Type: -

Identifier Source: org_study_id

NCT02568956

Identifier Type: -

Identifier Source: nct_alias