Cardiac Stem Cell Laboratory and Catheterization Laboratory 2014, The Hearth Centre, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.
Scand Cardiovasc J. 2011 Jun;45(3):161-8. doi: 10.3109/14017431.2011.569571. Epub 2011 Apr 12.
We evaluated the feasibility, safety and efficacy of intra-myocardial injection of autologous mesenchymal stromal cells derived endothelial progenitor cell (MSC) in patients with stable coronary artery disease (CAD) and refractory angina in this first in man trial.
A total of 31 patients with stable CAD, moderate to severe angina and no further revascularization options, were included. Bone marrow MSC were isolated and culture expanded for 6-8 weeks. It was feasible and safe to establish in-hospital culture expansion of autologous MSC and perform intra-myocardial injection of MSC. After six months follow-up myocardial perfusion was unaltered, but the patients increased exercise capacity (p < 0.001), reduction in CCS Class (p < 0.001), angina attacks (p < 0.001) and nitroglycerin consumption (p < 0.001), and improved Seattle Angina Questionnaire (SAQ) evaluations (p < 0.001). For all parameters there was a tendency towards improved outcome with increasing numbers of cells injected. In the MRI substudy: ejection fraction (p < 0.001), systolic wall thickness (p = 0.03) and wall thickening (p = 0.03) all improved.
The study demonstrated that it was safe to treat patients with stable CAD with autologous culture expanded MSC. Moreover, MSC treated patients had significant improvement in left ventricular function and exercise capacity, in addition to an improvement in clinical symptoms and SAQ evaluations.
我们评估了自体骨髓间充质基质细胞衍生内皮祖细胞(MSC)在稳定型冠状动脉疾病(CAD)和难治性心绞痛患者中的心肌内注射的可行性、安全性和疗效,这是首次人体试验。
共纳入 31 例稳定型 CAD、中重度心绞痛且无进一步血运重建选择的患者。分离和培养骨髓 MSC 6-8 周。建立自体 MSC 院内培养扩增和心肌内 MSC 注射是可行和安全的。随访 6 个月后,心肌灌注未改变,但患者运动能力增加(p<0.001),CCS 分级降低(p<0.001),心绞痛发作减少(p<0.001),硝化甘油消耗减少(p<0.001),西雅图心绞痛问卷(SAQ)评估改善(p<0.001)。对于所有参数,注射细胞数量增加,改善的趋势越明显。在 MRI 亚研究中:射血分数(p<0.001)、收缩期壁厚度(p=0.03)和壁增厚(p=0.03)均有改善。
该研究表明,用自体培养扩增的 MSC 治疗稳定型 CAD 患者是安全的。此外,MSC 治疗的患者左心室功能和运动能力显著改善,临床症状和 SAQ 评估也得到改善。