Vicario J, Campos C, Piva J, Faccio F, Gerardo L, Becker C, Ortega H H, Pierini A, Lofeudo C, Novero R, Licheri A, Milesi R, Perez Baliño N, Monti A, Amin A, Pfeiffer H, De Giovanni E, Fendrich I
J.B. Iturraspe Hospital, Santa Fe 3000, Argentina.
Cardiovasc Radiat Med. 2004 Apr-Jun;5(2):71-6. doi: 10.1016/j.carrad.2004.06.004.
Based on our preclinic studies with autologous unfractionated bone marrow (AUBM) via coronary sinus with transitory occlusion, a clinic study in patients with chronic stable angina was designed. The objectives were to evaluate safety, tolerance and feasibility.
A multicenter prospective study with inclusion and exclusion criteria defined by an Independent Clinical Committee was carried out. Fourteen patients underwent transcoronary sinus administration of freshly aspirated and filtered AUBM (60-120 ml). Safety and tolerance were evaluated. Feasibility was evaluated with Seattle Angina Questionnaire (SAQ), Canadian Cardiovascular Society (CCS) angina classification (baseline-Day 180), myocardial perfusion (baseline-Day 90) with independent core laboratory and coronary angiography (baseline and Day 30).
There were no changes in the safety and tolerance parameters. Preliminary clinical efficacy at Day 180 disclosed a significant improvement of 38%, evaluated by the SAQ. The CCS angina classification shows that the mean angina class was 3.0+/-0.55 at baseline and improved to 2.0+/-0.00 at Day 180 (P <.001). Semiquantitative radionuclide perfusion imaging (core lab) showed a significant improvement at Day 90 in 13/14 patients, with a mean improvement of 24% at rest (P <.01) and 33% at stress (P <.05). Coronary angiography showed more collateral vessels in 9/14 patients.
We can conclude that AUBM via coronary sinus with transitory occlusion is tolerable and safe. Significant improvement in the myocardial perfusion at Day 90 and in the quality of life at Day 180 was observed.
基于我们通过冠状动脉窦短暂闭塞进行自体未分级骨髓（AUBM）的临床前研究，设计了一项针对慢性稳定型心绞痛患者的临床研究。目的是评估安全性、耐受性和可行性。
开展了一项多中心前瞻性研究，纳入和排除标准由独立临床委员会确定。14例患者接受了经冠状动脉窦给予新鲜抽吸并过滤的AUBM（60 - 120毫升）。评估了安全性和耐受性。通过西雅图心绞痛问卷（SAQ）、加拿大心血管学会（CCS）心绞痛分级（基线 - 第180天）、由独立核心实验室进行的心肌灌注（基线 - 第90天）以及冠状动脉造影（基线和第30天）评估可行性。
安全性和耐受性参数无变化。第180天的初步临床疗效显示，通过SAQ评估有38%的显著改善。CCS心绞痛分级显示，基线时平均心绞痛分级为3.0±0.55，第180天改善至2.0±0.00（P <.001）。半定量放射性核素灌注成像（核心实验室）显示，第90天时14例患者中有13例有显著改善，静息时平均改善24%（P <.01），负荷时改善33%（P <.05）。冠状动脉造影显示14例患者中有9例出现更多侧支血管。
我们可以得出结论，通过冠状动脉窦短暂闭塞给予AUBM是可耐受且安全的。观察到第90天时心肌灌注有显著改善，第180天时生活质量有显著改善。
