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首页> 外文期刊>Journal of Clinical Medicine Research >Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability
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Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability

机译：自体基质血管部分静脉内治疗终末期慢性阻塞性肺疾病：一期安全性和耐受性试验

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Background: Chronic obstructive pulmonary disease (COPD) is a consistently progressive, ultimately fatal disease for which no treatment exists capable of either reversing or even interrupting its course. It afflicts more than 5% of the population in many countries, and it accordingly represents the third most frequent cause of death in the US, where it accounts for more than 600 billion in health care costs, morbidity, and mortality. Adipose tissue contains within its stromal compartment a high abundance of adipose stem/stromal cells (ASCs), which can be readily separated from the adipocyte population by methods which require less than 2 h of processing time and yield a concentrated cellular preparation termed the stromal vascular fraction (SVF). The SVF contains all cellular elements of fat, excluding adipocytes. Recent clinical studies have begun to explore the feasibility and safety of the local injection or intravascular delivery of SVF or more purified populations of ASCs derived by culture protocols. Several pre-clinical studies have demonstrated a remarkable ability of ASC to nearly fully ameliorate the progress of emphysema due to cigarette smoke exposure as well as other causes. However, no prior clinical studies have evaluated the safety of administration of either ASC or SVF in subjects with COPD. We hypothesized that harvest, isolation, and immediate intravenous infusion of autologous SVF would be feasible and safe in subjects with COPD; and that such an approach, if ultimately determined to be efficacious as well as safe, would provide a highly practical method for treatment of COPD.Methods: In this study, an initial phase I trial evaluating the early and delayed safety of SVF infusion was performed. Twelve subjects were enrolled in the study, in which adipose tissue was harvested using standard liposuction techniques, followed by SVF isolation and intravenous infusion of 150 - 300 million cells. Standardized questionnaires were administered to study feasibility as well as immediate and delayed outcomes and adverse events as primary endpoints. Secondary endpoints included subjective wellness and attitudes towards the procedure, as well as willingness to undergo the procedure a second time. The follow-up time ranged from 3 to 12 months, averaging 12 months.Results: Of the 12 subjects, only one experienced an immediate adverse event, related to bruising from the liposuction. No observed pulmonary or cardiac issues were observed as related to the procedure. There were no deaths over the 12-month study period, and none identified in the subsequent telephonic follow-up. Attitudes toward the procedure were predominantly positive, and 92% of the study subjects expressed a desire to undergo the procedure a second time.Conclusions: This study is the first to demonstrate safety of SVF infusion in humans with serious pulmonary disease. Specifically, the use of intravenous infusion as a route to achieve pulmonary cellular targeting did not lead to clinical pulmonary compromise. The intravenous administration of SVF should be further explored as a potentially feasible and safe method for delivery leading to possible therapeutic benefit.J Clin Med Res. 2017;9(8):701-708doi: https://doi.org/10.14740/jocmr3072w
机译：背景：慢性阻塞性肺疾病（COPD）是一种持续发展的，最终致命的疾病，目前尚无能够逆转甚至中断其病程的治疗方法。它困扰着许多国家超过5％的人口，因此，它是美国第三大最常见的死因，在美国，它的医疗保健成本，发病率和死亡率超过6000亿。脂肪组织在其基质室中含有大量的脂肪干/基质细胞（ASC），可通过需要少于2小时的处理时间并产生称为基质血管的浓缩细胞制剂的方法，将脂肪干/基质细胞与脂肪细胞群体轻松分离。分数（SVF）。 SVF包含脂肪的所有细胞成分，但脂肪细胞除外。最近的临床研究已经开始探索局部注射或通过培养方案衍生的SVF或更纯的ASC群体的局部注射或血管内递送的可行性和安全性。几项临床前研究表明，ASC具有显着的能力，可以几乎完全缓解由于吸烟和其他原因引起的肺气肿的进展。但是，目前尚无临床研究评估过COPD受试者ASC或SVF的安全性。我们假设在COPD患者中，自体SVF的收获，分离和立即静脉内输注将是可行和安全的。并且该方法，如果最终确定是有效且安全的，将为治疗COPD提供高度实用的方法。方法：在这项研究中，进行了评估SVF输注的早期和延迟安全性的初始I期试验。 。该研究招募了十二名受试者，其中使用标准的吸脂技术收集脂肪组织，然后进行SVF分离和静脉内输注150-3亿个细胞。进行标准化问卷调查以研究可行性以及即时和延迟结果以及不良事件为主要终点。次要终点包括主观健康和对手术的态度，以及第二次接受手术的意愿。随访时间为3到12个月，平均12个月。结果：在12名受试者中，只有一名经历了与吸脂引起的瘀伤有关的直接不良事件。没有观察到与手术相关的肺部或心脏问题。在为期12个月的研究期内没有死亡，在随后的电话随访中也没有发现死亡。对手术的态度主要是积极的，有92％的研究对象表示希望第二次接受手术。结论：本研究首次证明了SVF输注对严重肺部疾病患者的安全性。具体而言，使用静脉输液作为实现肺细胞靶向的途径并未导致临床肺功能损害。 SVF的静脉内给药应进一步探索作为一种潜在可行且安全的给药方法，从而带来可能的治疗效果。JClin Med Res。 2017; 9（8）：701-708doi：https://doi.org/10.14740/jocmr3072w

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