Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.
Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.
J Vasc Interv Radiol. 2021 Feb;32(2):157-163. doi: 10.1016/j.jvir.2020.09.003. Epub 2020 Nov 25.
To evaluate safety and efficacy of angiogenesis induced by intraarterial autologous bone marrow-derived stem cell (BMSC) injection in patients with severe peripheral arterial disease (PAD).
Eighty-one patients with severe PAD (77 men), including 56 with critical limb ischemia (CLI) and 25 with severe claudication, were randomized to receive sham injection (group A) or intraarterial BMSC injection at the site of occlusion (group B). Primary endpoints included improvement in ankle-brachial index (ABI) of > 0.1 and transcutaneous pressure of oxygen (TcPO) of > 15% at mid- and lower foot at 6 mo. Secondary endpoints included relief from rest pain, > 30% reduction in ulcer size, and reduction in major amputation in patients with CLI and > 50% improvement in pain-free walking distance in patients with severe claudication.
Technical success was achieved in all patients, without complications. At 6 mo, group B showed more improvements in ABI of > 0.1 (35 of 41 [85.37%] vs 13 of 40 [32.50%]; P < .0001) and TcPO of > 15% at the midfoot (35 of 41 [85.37%] vs 17 of 40 [42.50%]; P = .0001] and lower foot (37 of 41 [90.24%] vs 19 of 40 [47.50%]; P < .0001). No patients with CLI underwent major amputation in group B, compared with 4 in group A (P = .0390). No significant difference was observed in relief from rest pain or > 30% reduction in ulcer size among patients with CLI or in > 50% improvement in pain-free walking distance among patients with severe claudication.
Intraarterial delivery of autologous BMSCs is safe and effective in the management of severe PAD.
评估经动脉自体骨髓源性干细胞（BMSC）注射治疗严重外周动脉疾病（PAD）患者的安全性和疗效。
81 例严重 PAD 患者（77 例男性），包括 56 例严重肢体缺血（CLI）患者和 25 例严重跛行患者，随机分为接受假注射（A 组）或动脉内 BMSC 注射闭塞部位（B 组）。主要终点包括 6 个月时踝肱指数（ABI）提高≥0.1 和中、足底经皮氧分压（TcPO）提高≥15%。次要终点包括 CLI 患者的静息痛缓解、溃疡面积缩小≥30%和大截肢减少以及严重跛行患者的无痛行走距离增加≥50%。
所有患者均获得技术成功，无并发症。6 个月时，B 组 ABI 提高≥0.1 的患者更多（35/41[85.37%]比 13/40[32.50%]；P<0.0001），中足底 TcPO 提高≥15%的患者更多（35/41[85.37%]比 17/40[42.50%]；P=0.0001）和足底 TcPO 提高≥15%的患者更多（37/41[90.24%]比 19/40[47.50%]；P<0.0001）。B 组无 CLI 患者行大截肢，而 A 组有 4 例（P=0.0390）。CLI 患者的静息痛缓解或溃疡面积缩小≥30%或严重跛行患者的无痛行走距离增加≥50%无显著差异。
经动脉自体 BMSC 递送治疗严重 PAD 安全且有效。
