Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease
NCT ID: NCT02504437
Last Updated: 2015-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2015-11-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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pre-conditioned BMMSCs
autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction.
BMMSCs
BMMSCs
autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition.
BMMSCs
Controls
standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion.
BMMSCs
Interventions
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BMMSCs
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Academy Military Medical Science, China
INDUSTRY
Responsible Party
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Xuetao Pei
Director, Head of South China Research Center for Stem Cell & Regenerative Medicine, AMMS, Guangzhou, China.
Central Contacts
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References
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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.
Other Identifiers
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BMMSC-1
Identifier Type: -
Identifier Source: org_study_id
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