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自体成年原代祖细胞(来源于皮下脂肪组织)治疗静脉和混合静脉动脉来源的下肢溃疡:一项前瞻性临床初步研究。

Therapy of ulcus cruris of venous and mixed venous arterial origin with autologous, adult, native progenitor cells from subcutaneous adipose tissue: a prospective clinical pilot study.

机构信息

Department of Dermatology and Allergology, Technical University Munich, Munich, Germany.

School of Medicine, Epigenetic of Aging, Technical University Munich, Garching, Germany.

出版信息

J Eur Acad Dermatol Venereol. 2017 Dec;31(12):2104-2118. doi: 10.1111/jdv.14489. Epub 2017 Sep 4.

DOI:10.1111/jdv.14489
PMID:28750144
Abstract

BACKGROUND

The stromal vascular fraction (SVF) of adipose tissue consists of cellular subpopulations with distinct regenerative potential.

OBJECTIVE

To investigate the regenerative capacities of autologous SVF cells in the treatment of chronic leg ulcers of venous (VLU) and arterial-venous (AVLU) origin.

METHODS

Multimorbid ulcer patients received a singular topical treatment with 9-15 × 10 SVF cells, separated from abdominal lipoaspirates by digestion with collagenase and neutral protease and applied immediately after isolation. The primary endpoints were the change in wound size 12 weeks after treatment and evaluation of adverse events. Secondary endpoints included the time to complete wound epithelialization and change in pain levels. Postoperative wound treatment modalities and treatment of comorbidities were not intensified compared with pre-operative management. Follow-up period was at least 6 months.

RESULTS

Sixteen elderly ulcer patients (seven with VLU, nine with AVLU) were treated as described. All VLU patients (median ulcer size: 48.25 cm ) and four of nine AVLU patients showed complete epithelialization of the ulcers within 71-174 days. In three patients with large ulcerations on both legs, ulcerations on the non-treated, contralateral leg also epithelialized. Patients reported a considerable rapid decrease in pain intensity by 2.5 points on average on a visual scale from 1 to 5 within the first 2 weeks after treatment. The patients were followed up for 9-44 months (median: 30 months). No severe side-effects were observed.

CONCLUSIONS

The use of SVF cells presents an effective, minimally invasive option for the treatment of VLU and AVLU even in multimorbid patients. In patients with larger predominantly ischaemic AVLU and comorbidities, one-time application of the used amounts of SVF cells was not sufficient in the majority of cases.

摘要

背景

脂肪组织的基质血管部分(SVF)由具有明显再生潜力的细胞亚群组成。

目的

研究自体 SVF 细胞在治疗静脉(VLU)和动静脉(AVLU)来源慢性腿部溃疡中的再生能力。

方法

多系统疾病溃疡患者接受单次局部治疗,使用 9-15×10 SVF 细胞,从腹部脂肪抽吸物中分离出来,用胶原酶和中性蛋白酶消化,并在分离后立即应用。主要终点是治疗后 12 周的伤口大小变化和不良事件评估。次要终点包括完全上皮化时间和疼痛水平变化。与术前管理相比,术后伤口处理方式和合并症治疗并未加强。随访期至少为 6 个月。

结果

按上述方法治疗了 16 名老年溃疡患者(7 名 VLU,9 名 AVLU)。所有 VLU 患者(中位溃疡大小:48.25cm )和 9 名 AVLU 患者中的 4 名在 71-174 天内完全上皮化。在 3 名双腿有大溃疡的患者中,非治疗侧的溃疡也上皮化了。患者报告在治疗后 2 周内平均疼痛强度平均降低了 2.5 分,从 1 到 5 的视觉量表上。患者随访 9-44 个月(中位数:30 个月)。未观察到严重的副作用。

结论

即使在多系统疾病患者中,SVF 细胞的使用也是一种有效、微创的治疗 VLU 和 AVLU 的选择。在大多数情况下,对于较大的主要缺血性 AVLU 和合并症患者,一次性应用所使用的 SVF 细胞量是不够的。

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