Ren Bin, Chang Yiqiang, Liu Ruolan, Xiao Feng, Xu Jun, Li Lingsong, Li Tao, Ruan Zhao, Bao Yigui, Lin Junbing, Zhou Junying, Liao Weijing, Pan Zhenyu, Xu Haibo, Tian Jun, Cai Lin, Zheng Xin Xiao
Department of Orthopedics, Zhongnan Hospital of Wuhan University, Wuhan, China.
Department of Rehabilitation Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.
Front Cell Dev Biol. 2023 Jan 19;11:1106279. doi: 10.3389/fcell.2023.1106279. eCollection 2023.
The clinical applications of stromal vascular fraction (SVF) therapy for osteoarthritis (OA) have attracted academic and clinical attention. However, data of the effects of stromal vascular fraction therapy on regeneration of degenerated cartilage are limited in the literature. Meanwhile, there is a great need for a simple and non-invasive evaluation method to analyze the changes of joint cartilage qualitatively and quantitatively in clinical trials. This study entitled "stromal vascular fraction Therapy for Human Knee Osteoarthritis" was registered in ClinicalTrial.gov # NCT05019378. We designed and conducted a single center, open labeled clinical phase I/II study, and 6 osteoarthritis patients with both knee cartilage defect I-II were enrolled in this study. The two knees of each patient were randomly assigned to autologous stromal vascular fraction treatment group or non-treatment control group to evaluate the safety and therapeutic effect of stromal vascular fraction therapy for human knee osteoarthritis. We have also established a novel protocol to provide 3D MRI imaging for human knee cartilage enabling us to qualitatively and quantitatively evaluate cartilage degeneration and regeneration in this study. The qualitative and quantitative evaluation of 3D Magnetic Resonance Imaging (MRI) imaging of knee cartilage demonstrated that the stromal vascular fraction therapy reduced the cartilage defects; and significant increase of cartilage value both in defect cartilage area and whole cartilage area of treated group and significant increase of thickness and area of both femoral and tibia cartilage in vertical sections of the stromal vascular fraction treated Group at 12 and 24 W post treatment in cartilage defect I-II osteoarthritis patients. This clinical phase I/II study indicated that stromal vascular fraction therapy is a safe clinical procedure and provided evidence that the stromal vascular fraction therapy significantly facilitated cartilage regeneration, opening the opportunity to a phase III trial investigating authentic efficacy of the procedure. This study is the first qualitative and quantitative evaluation of the efficacy of autologous stromal vascular fraction cellular therapy on cartilage regeneration. Through early and definite diagnosis of knee osteoarthritis patients, and providing safe and efficient therapy to facilitate cartilage regeneration, we will be able to control or reverse cartilage degeneration and completely change the epidemiology of osteoarthritis worldwide.
基质血管组分(SVF)疗法在骨关节炎(OA)中的临床应用已引起学术界和临床界的关注。然而,关于基质血管组分疗法对退变软骨再生影响的数据在文献中有限。同时,在临床试验中非常需要一种简单且非侵入性的评估方法来定性和定量分析关节软骨的变化。这项名为“基质血管组分疗法治疗人类膝关节骨关节炎”的研究已在ClinicalTrial.gov上注册,编号为#NCT05019378。我们设计并开展了一项单中心、开放标签的临床I/II期研究,招募了6例双膝均存在I-II级软骨缺损的骨关节炎患者。将每位患者的双膝随机分配至自体基质血管组分治疗组或非治疗对照组,以评估基质血管组分疗法治疗人类膝关节骨关节炎的安全性和治疗效果。我们还建立了一种新方案,可为人类膝关节软骨提供3D MRI成像,使我们能够在本研究中定性和定量评估软骨退变和再生情况。膝关节软骨的3D磁共振成像(MRI)定性和定量评估表明,基质血管组分疗法减少了软骨缺损;在软骨缺损I-II级骨关节炎患者治疗后12周和24周时,治疗组缺损软骨区域和整个软骨区域的软骨值显著增加,基质血管组分治疗组垂直切片中股骨和胫骨软骨的厚度和面积也显著增加。这项临床I/II期研究表明,基质血管组分疗法是一种安全的临床操作,并提供了证据表明基质血管组分疗法显著促进了软骨再生,为开展一项研究该疗法真实疗效的III期试验提供了机会。本研究是对自体基质血管组分细胞疗法对软骨再生疗效的首次定性和定量评估。通过对膝关节骨关节炎患者进行早期明确诊断,并提供安全有效的治疗以促进软骨再生,我们将能够控制或逆转软骨退变,并彻底改变全球骨关节炎的流行病学状况。
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