Xinyang Hu1, Xin Huang2, Qian Yang3, Lihua Wang4, Jianzhong Sun4, Hongwei Zhan5, Jianjing Lin6, Zhaoxia Pu7, Jun Jiang6, Yong Sun6, Meixiang Xiang6, Xianbao Liu6, Xiaojie Xie6, Xia Yu6, Zexin Chen2, Hung-Fat Tse8, Jianyi Zhang9, Jian'an Wang10. 1. Department of Cardiology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China. 2. Cardiovascular Key Laboratory of Zhejiang Province, Hangzhou, PR China. 3. Department of Cardiology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China; Cardiovascular Key Laboratory of Zhejiang Province, Hangzhou, PR China; Department of ultrasonography, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China. 4. Department of radiology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China. 5. Department of Nuclear Medicine, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China. 6. Department of Cardiology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China; Cardiovascular Key Laboratory of Zhejiang Province, Hangzhou, PR China. 7. Department of ultrasonography, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China. 8. Cardiology Division, Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hong Kong, HKSAR, PR China; Shenzhen Institutes of Research and Innovation, the University of Hong Kong, Hong Kong SAR, PR China. 9. Department of Biomedical Engineering, University of Minnesota, Minneapolis, MN, USA. 10. Department of Cardiology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China; Cardiovascular Key Laboratory of Zhejiang Province, Hangzhou, PR China. Electronic address: jian_an_wang@yahoo.com.
Abstract
BACKGROUND: Pre-clinical studies have shown that hypoxia preconditioning can enhance stem cell therapeutic potential for myocardial repair. We sought to investigate the safety and feasibility of intracoronary administration of hypoxia-preconditioned bone marrow mononuclear cells (HP-BMCs) for acute ST segment elevation myocardial infarction (STEMI). METHODS: We randomized 22 patients with acute STEMI to receiveintracoronary administration of normoxia bone marrow mononuclear cells (N-BMCs) (n=11) or HP-BMCs (n=11) following successful reperfusion. Another 14 patients receiving standard therapy were recruited as control (n=14). RESULTS: There were no differences in the occurrence of major adverse cardiovascular events at 30 days and 1 year among three groups. There were significant improvement in the change of left ventricular end-diastolic volume (LVEDV) and end-systolic volume (LVESV) in HP-BMC group both at 6 and 12 months compared with N-BMCs or control group (P<0.05). No differences were observed in the change of left ventricular ejection fraction (LVEF), or wall motion score index (WMSI) among three groups. Nevertheless, WMSI was improved in HP-BMCs and N-BMC group (P<0.05, within group), but not in control. The ratio of myocardial perfusion defect determined by SPECT was significantly decreased in HP-BMCs and N-BMC groups at 6months compared with baseline (P<0.05, within group), but no significant differences were observed among three groups. CONCLUSIONS: Our results provide the first-in-man evidence that intracoronary administration of HP-BMCs following acute MI appears to be safe and feasible. These results provide the basis for future prospective randomized clinical trials in a larger patient cohort. CLINICAL TRIAL REGISTRATION INFORMATION: NCT01234181 (http://clinicaltrials.gov/ct2/show/NCT01234181?term=NCT01234181&rank=1).
RCT Entities:
BACKGROUND: Pre-clinical studies have shown that hypoxia preconditioning can enhance stem cell therapeutic potential for myocardial repair. We sought to investigate the safety and feasibility of intracoronary administration of hypoxia-preconditioned bone marrow mononuclear cells (HP-BMCs) for acute ST segment elevation myocardial infarction (STEMI). METHODS: We randomized 22 patients with acute STEMI to receive intracoronary administration of normoxia bone marrow mononuclear cells (N-BMCs) (n=11) or HP-BMCs (n=11) following successful reperfusion. Another 14 patients receiving standard therapy were recruited as control (n=14). RESULTS: There were no differences in the occurrence of major adverse cardiovascular events at 30 days and 1 year among three groups. There were significant improvement in the change of left ventricular end-diastolic volume (LVEDV) and end-systolic volume (LVESV) in HP-BMC group both at 6 and 12 months compared with N-BMCs or control group (P<0.05). No differences were observed in the change of left ventricular ejection fraction (LVEF), or wall motion score index (WMSI) among three groups. Nevertheless, WMSI was improved in HP-BMCs and N-BMC group (P<0.05, within group), but not in control. The ratio of myocardial perfusion defect determined by SPECT was significantly decreased in HP-BMCs and N-BMC groups at 6months compared with baseline (P<0.05, within group), but no significant differences were observed among three groups. CONCLUSIONS: Our results provide the first-in-man evidence that intracoronary administration of HP-BMCs following acute MI appears to be safe and feasible. These results provide the basis for future prospective randomized clinical trials in a larger patient cohort. CLINICAL TRIAL REGISTRATION INFORMATION: NCT01234181 (http://clinicaltrials.gov/ct2/show/NCT01234181?term=NCT01234181&rank=1).
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