Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease (TPAABPIHD)
Primary Purpose
Myocardial Infarction, Acute Myocardial Infarction, Ischemic Cardiomyopathy
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BMMSCs
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Age under 75;
- Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy
- NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%;
- No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS;
- No psychiatric illnesses and speaking dysfunction;
- Informed consent.
Exclusion Criteria:
- More than 75 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
pre-conditioned BMMSCs
BMMSCs
Controls
Arm Description
autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.
autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.
standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.
Outcomes
Primary Outcome Measures
LVEF (left ventricular ejection fraction)
Secondary Outcome Measures
Full Information
NCT ID
NCT02504437
First Posted
July 14, 2015
Last Updated
July 20, 2015
Sponsor
Academy Military Medical Science, China
Collaborators
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02504437
Brief Title
Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease
Acronym
TPAABPIHD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academy Military Medical Science, China
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 efficacy of the preconditioned autologous bone marrow 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
Myocardial Infarction, Acute Myocardial Infarction, Ischemic Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pre-conditioned BMMSCs
Arm Type
Experimental
Arm Description
autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.
Arm Title
BMMSCs
Arm Type
Active Comparator
Arm Description
autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.
Arm Title
Controls
Arm Type
Sham Comparator
Arm Description
standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.
Intervention Type
Biological
Intervention Name(s)
BMMSCs
Primary Outcome Measure Information:
Title
LVEF (left ventricular ejection fraction)
Time Frame
one year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age under 75;
Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy
NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%;
No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS;
No psychiatric illnesses and speaking dysfunction;
Informed consent.
Exclusion Criteria:
More than 75 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.
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.
Results Reference
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Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease
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