Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)
Primary Purpose
Acute Myocardial Infarction, Myocardial Infarction, Ischemic Cardiomyopathy
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
umbilical cord mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
UCMSCs
controls
Arm Description
Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)
Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion
Outcomes
Primary Outcome Measures
Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.
Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).
Secondary Outcome Measures
Pump failure Killip classification
New York Heart Association(NYHA) classification
Occurrence of major adverse event
Full Information
NCT ID
NCT02666391
First Posted
January 21, 2016
Last Updated
January 24, 2016
Sponsor
South China Research Center for Stem Cell and Regenerative Medicine
Collaborators
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02666391
Brief Title
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South China Research Center for Stem Cell and Regenerative Medicine
Collaborators
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Myocardial Infarction, Ischemic Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UCMSCs
Arm Type
Experimental
Arm Description
Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)
Arm Title
controls
Arm Type
No Intervention
Arm Description
Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion
Intervention Type
Biological
Intervention Name(s)
umbilical cord mesenchymal stem cells
Primary Outcome Measure Information:
Title
Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.
Time Frame
1 week, 6 month, 12 month,18 month
Title
Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).
Time Frame
1 week, 18 month
Secondary Outcome Measure Information:
Title
Pump failure Killip classification
Time Frame
baseline, 1 week, 1 month, 6 month, 12 month,18 month
Title
New York Heart Association(NYHA) classification
Time Frame
1 week, 1 month, 6 month, 12 month,18 month
Title
Occurrence of major adverse event
Time Frame
3 day, 1 week, 1 month, 6 month, 12 month,18 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuetao Pei, M.D., Ph.D
Phone
8610-68164807
Email
AMMS0906@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junnian Zhou, Ph.D
Phone
8620-89199011
Email
zhoujunnian@scrm.org.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
23651816
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.
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Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)
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