Abstract：
OBJECTIVE: The purpose of this study was to evaluate the yield, viability, clinical safety, and efficacy of the stromal vascular fraction (SVF) separated with a new protocol with all clinical-grade drugs.
METHODS: SVF cells were isolated from lipoaspirate obtained from 13 participants aged from 30 to 56 years by using a new clinical protocol and the laboratory protocol. The cell yield, viability, morphology, mesenchymal stem cell (MSC) surface marker expression, and differentiation abilities of the SVF cells harvested from the two protocols were compared. Furthermore, three related clinical trials were conducted to verify the safety and efficiency of SVF cells isolated by the new clinical protocol.
RESULTS: There were no significant differences in the yield, viability, morphology, and differentiation potential of the SVFs isolated with the clinical protocol and laboratory protocol. Adipose-derived mesenchymal stem cell (ASC) surface marker expression, including that of CD14, CD31, CD44, CD90, CD105, and CD133, was consistent between the two protocols. Clinical trials have demonstrated the effectiveness of the SVF isolated with the new clinical protocol in improving skin grafting, promoting mechanical stretch-induced skin regeneration and improving facial skin texture. No complications occurred.
CONCLUSIONS: SVF isolated by the new clinical protocol had a noninferior yield and viability to that of the SVF separated by the laboratory protocol. SVFs obtained by the new protocol can be safely and effectively applied to improve skin grafting, promote mechanical stretch-induced skin regeneration, and improve facial skin texture.
BACKGROUND: The trials were registered with the ClinicalTrials.gov (NCT03189628), the Chinese Clinical Trial Registry (ChiCTR2000039317), and the ClinicalTrials.gov (NCT02546882). All the three trials were not patient-funded trials.
METHODS: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
METHODS: SVF cells were isolated from lipoaspirate obtained from 13 participants aged from 30 to 56 years by using a new clinical protocol and the laboratory protocol. The cell yield, viability, morphology, mesenchymal stem cell (MSC) surface marker expression, and differentiation abilities of the SVF cells harvested from the two protocols were compared. Furthermore, three related clinical trials were conducted to verify the safety and efficiency of SVF cells isolated by the new clinical protocol.
RESULTS: There were no significant differences in the yield, viability, morphology, and differentiation potential of the SVFs isolated with the clinical protocol and laboratory protocol. Adipose-derived mesenchymal stem cell (ASC) surface marker expression, including that of CD14, CD31, CD44, CD90, CD105, and CD133, was consistent between the two protocols. Clinical trials have demonstrated the effectiveness of the SVF isolated with the new clinical protocol in improving skin grafting, promoting mechanical stretch-induced skin regeneration and improving facial skin texture. No complications occurred.
CONCLUSIONS: SVF isolated by the new clinical protocol had a noninferior yield and viability to that of the SVF separated by the laboratory protocol. SVFs obtained by the new protocol can be safely and effectively applied to improve skin grafting, promote mechanical stretch-induced skin regeneration, and improve facial skin texture.
BACKGROUND: The trials were registered with the ClinicalTrials.gov (NCT03189628), the Chinese Clinical Trial Registry (ChiCTR2000039317), and the ClinicalTrials.gov (NCT02546882). All the three trials were not patient-funded trials.
METHODS: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
摘要：
目的：本研究的目的是评估产量，生存能力，临床安全,和基质血管分数（SVF）的功效用所有临床级药物的新方案分开。
方法：使用新的临床方案和实验室方案，从13名年龄在30至56岁的参与者的脂肪抽吸物中分离出SVF细胞。细胞产量，生存能力，形态学,间充质干细胞（MSC）表面标志物表达，比较了从两种方案中收获的SVF细胞的分化能力。此外，我们进行了三项相关临床试验,以验证通过新临床方案分离的SVF细胞的安全性和有效性.
结果：产量没有显著差异，生存能力，形态学,以及用临床方案和实验室方案分离的SVF的分化潜力。脂肪间充质干细胞(ASC)表面标志物表达,包括CD14,CD31,CD44,CD90,CD105和CD133的表达在两种方案之间是一致的.临床试验已经证明了与新临床方案分离的SVF在改善皮肤移植方面的有效性，促进机械拉伸诱导的皮肤再生，改善面部皮肤质地。无并发症发生。
结论：通过新的临床方案分离的SVF具有与通过实验室方案分离的SVF相比不差的产量和活力。通过新协议获得的SVFs可以安全有效地应用于改善皮肤移植，促进机械拉伸诱导的皮肤再生，改善面部皮肤纹理。
背景：试验已在ClinicalTrials.gov（NCT03189628）注册，中国临床试验注册中心(ChiCTR2000039317),和ClinicalTrials.gov（NCT02546882）。所有这三个试验都不是患者资助的试验。
方法：本期刊要求作者为每个提交的证据分配一个级别，该级别的证据适用于循证医学排名。这不包括评论文章，书评,和有关基础科学的手稿，动物研究,尸体研究，和实验研究。对于这些循证医学评级的完整描述，请参阅目录或在线作者说明www。springer.com/00266.
方法：使用新的临床方案和实验室方案，从13名年龄在30至56岁的参与者的脂肪抽吸物中分离出SVF细胞。细胞产量，生存能力，形态学,间充质干细胞（MSC）表面标志物表达，比较了从两种方案中收获的SVF细胞的分化能力。此外，我们进行了三项相关临床试验,以验证通过新临床方案分离的SVF细胞的安全性和有效性.
结果：产量没有显著差异，生存能力，形态学,以及用临床方案和实验室方案分离的SVF的分化潜力。脂肪间充质干细胞(ASC)表面标志物表达,包括CD14,CD31,CD44,CD90,CD105和CD133的表达在两种方案之间是一致的.临床试验已经证明了与新临床方案分离的SVF在改善皮肤移植方面的有效性，促进机械拉伸诱导的皮肤再生，改善面部皮肤质地。无并发症发生。
结论：通过新的临床方案分离的SVF具有与通过实验室方案分离的SVF相比不差的产量和活力。通过新协议获得的SVFs可以安全有效地应用于改善皮肤移植，促进机械拉伸诱导的皮肤再生，改善面部皮肤纹理。
背景：试验已在ClinicalTrials.gov（NCT03189628）注册，中国临床试验注册中心(ChiCTR2000039317),和ClinicalTrials.gov（NCT02546882）。所有这三个试验都不是患者资助的试验。
方法：本期刊要求作者为每个提交的证据分配一个级别，该级别的证据适用于循证医学排名。这不包括评论文章，书评,和有关基础科学的手稿，动物研究,尸体研究，和实验研究。对于这些循证医学评级的完整描述，请参阅目录或在线作者说明www。springer.com/00266.
