Darinskas Adas, Paskevicius Mindaugas, Apanavicius Gintaras, Vilkevicius Gintaris, Labanauskas Liutauras, Ichim Thomas E, Rimdeika Rytis
Laboratory of Immunology, National Cancer Institute, Santariskiu Str. 1, 08660, Vilnius, Lithuania.
Department of Vascular Surgery, Vilnius City Clinical Hospital, Antakalnio Str. 57, 10207, Vilnius, Lithuania.
J Transl Med. 2017 Jun 19;15(1):143. doi: 10.1186/s12967-017-1243-3.
Cell-based therapy is being explored as an alternative treatment option for critical limb ischemia (CLI), a disease associated with high amputation and mortality rates and poor quality of life. However, therapeutic potential of uncultured adipose-derived stromal vascular fraction (SVF) cells has not been evaluated as a possible treatment. In this pilot study, we investigated the efficacy of multiple injections of autologous uncultured adipose-derived SVF cells to treat patients with CLI.
This study included 15 patients, from 35 to 77 years old, with rest pain and ulceration. SVF cells were injected once or twice in the ischemic limb along the arteries. Digital subtraction angiography was performed before and after cell therapy. The clinical follow up was carried out for the subsequent 12 months after the beginning of the treatment.
Multiple intramuscular SVF cell injections caused no complications during the follow-up period. Clinical improvement occurred in 86.7% of patients. Two patients required major amputation, and the amputation sites healed completely. The rest of patients achieved a complete ulcer healing, pain relief, improved ankle-brachial pressure index and claudication walking distance, and had ameliorated their quality of life. Digital subtraction angiography performed before and after SVF cell therapy showed formation of numerous vascular collateral networks across affected arteries.
Results of this pilot study demonstrate that the multiple intramuscular SVF cell injections stimulate regeneration of injured tissue and are effective alternative to achieve therapeutic angiogenesis in CLI patients who are not eligible for conventional treatment. Trial registration number at ISRCTN registry, ISRCTN13001382. Retrospectively registered at 26/04/2017.
基于细胞的疗法正在被探索作为严重肢体缺血（CLI）的一种替代治疗选择，CLI是一种与高截肢率、高死亡率及低生活质量相关的疾病。然而，未经培养的脂肪源性基质血管成分（SVF）细胞的治疗潜力尚未作为一种可能的治疗方法进行评估。在这项初步研究中，我们调查了多次注射自体未经培养的脂肪源性SVF细胞治疗CLI患者的疗效。
本研究纳入了15例年龄在35至77岁之间、有静息痛和溃疡的患者。将SVF细胞沿动脉在缺血肢体中注射一次或两次。在细胞治疗前后进行数字减影血管造影。在治疗开始后的接下来12个月进行临床随访。
多次肌肉内注射SVF细胞在随访期间未引起并发症。86.7%的患者出现临床改善。2例患者需要进行大截肢，截肢部位完全愈合。其余患者实现了溃疡完全愈合、疼痛缓解、踝肱压力指数改善、跛行步行距离增加，并且生活质量得到改善。SVF细胞治疗前后进行的数字减影血管造影显示，在受影响的动脉中形成了许多血管侧支网络。
这项初步研究的结果表明，多次肌肉内注射SVF细胞可刺激受损组织的再生，对于不符合传统治疗条件的CLI患者而言，是实现治疗性血管生成的有效替代方法。ISRCTN注册中心的试验注册号为ISRCTN13001382。于2017年4月26日进行回顾性注册。
