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脂肪组织源性间充质基质/干细胞在兔骨关节炎模型中的使用安全性研究，以支持 I 期临床试验。

Safety Studies for Use of Adipose Tissue-Derived Mesenchymal Stromal/Stem Cells in a Rabbit Model for Osteoarthritis to Support a Phase I Clinical Trial.

机构信息

Department of Orthopedic Surgery, Mayo Clinic College of Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Department of Orthopedic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.

出版信息

Stem Cells Transl Med. 2017 Mar;6(3):910-922. doi: 10.5966/sctm.2016-0097. Epub 2016 Oct 26.

DOI:10.5966/sctm.2016-0097
PMID:28297568
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5442773/
Abstract

Adipose-derived mesenchymal stem cells (AMSCs) offer potential as a therapeutic option for clinical applications in musculoskeletal regenerative medicine because of their immunomodulatory functions and capacity for trilineage differentiation. In preparation for a phase I clinical trial using AMSCs to treat patients with osteoarthritis, we carried out preclinical studies to assess the safety of human AMSCs within the intra-articular joint space. Culture-expanded human AMSCs grown in human platelet-lysate were delivered via intra-articular injections into normal healthy rabbit knees and knees at risk for the development of osteoarthritis after bilateral medial anterior hemimeniscectomy. Treatment outcomes and safety were evaluated by assessing the general health, function, and behavior of the animals. Joint tissues were analyzed by x-ray, magnetic resonance imaging, and histopathology. Intra-articular AMSC therapy was well tolerated in this study. We did not observe adverse systemic reactions, nor did we find evidence of damage to intra-articular joint tissues. Thus, the data generated in this study show a favorable safety profile for AMSCs within the joint space in support of a phase I clinical trial evaluating the clinical utility of AMSCs to treat osteoarthritis. Stem Cells Translational Medicine 2017;6:910-922.

摘要

脂肪间充质干细胞（ADSCs）具有免疫调节功能和三系分化能力，为肌肉骨骼再生医学的临床应用提供了潜在的治疗选择。为了准备使用 ADSCs 治疗骨关节炎患者的 I 期临床试验，我们进行了临床前研究，以评估关节内空间中人类 ADSCs 的安全性。在人类血小板裂解液中培养扩增的人类 ADSCs 通过关节内注射到正常健康的兔膝关节和双侧前内侧半月板切除后有发生骨关节炎风险的膝关节中。通过评估动物的一般健康状况、功能和行为来评估治疗效果和安全性。通过 X 射线、磁共振成像和组织病理学分析关节组织。在这项研究中，关节内 AMSC 治疗具有良好的耐受性。我们没有观察到全身不良反应，也没有发现关节内组织损伤的证据。因此，这项研究产生的数据显示，关节内空间中的 ADSCs 具有良好的安全性，支持 I 期临床试验评估 ADSCs 治疗骨关节炎的临床应用。《干细胞转化医学》2017 年；6:910-922.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/9ed25d1cc5eb/SCT3-6-0910-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/c8f152f08d92/SCT3-6-0910-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/f2898577d6ea/SCT3-6-0910-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/e6e6163b2ef9/SCT3-6-0910-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/1d48714689eb/SCT3-6-0910-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/eda3c4365e89/SCT3-6-0910-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/6812a59ded3c/SCT3-6-0910-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/9ed25d1cc5eb/SCT3-6-0910-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/c8f152f08d92/SCT3-6-0910-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/f2898577d6ea/SCT3-6-0910-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/e6e6163b2ef9/SCT3-6-0910-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/1d48714689eb/SCT3-6-0910-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/eda3c4365e89/SCT3-6-0910-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/6812a59ded3c/SCT3-6-0910-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4b9/5442773/9ed25d1cc5eb/SCT3-6-0910-g007.jpg

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