脐带华通氏胶治疗膝骨关节炎：一项非随机、开放标签、多中心试验的研究方案
Umbilical cord-derived Wharton's jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial.
作者信息
Gupta Ashim, Maffulli Nicola, Rodriguez Hugo C, Lee Cassidy E, Levy Howard J, El-Amin Saadiq F
机构信息
BioIntegrate, Lawrenceville, GA, USA.
Future Biologics, Lawrenceville, GA, USA.
出版信息
J Orthop Surg Res. 2021 Feb 18;16(1):143. doi: 10.1186/s13018-021-02300-0.
BACKGROUND
Osteoarthritis (OA) is the most common joint disorder in the USA, and knee OA has the highest prevalence. Inflammation and decrease in vascularization are key factors in the degeneration of articular cartilage and the associated pain and decrease in function. To combat this process, the use of biologics including umbilical cord-derived Wharton's Jelly (UC-derived WJ) has grown. UC-derived WJ contains large quantities of regenerative factors, including growth factors (GFs), cytokines (CKs), hyaluronic acid (HA), and extracellular vesicles (EVs). The proposed study evaluates the safety and efficacy of intraarticular injection of UC-derived WJ for treatment of knee OA symptoms.
METHODS AND ANALYSIS
This is a non-randomized, open-label, multi-center, prospective study in which the safety and efficacy of intraarticular UC-derived WJ in patients suffering from grade II/III OA will be assessed. Twelve patients with grade II/III OA who meet the inclusion and exclusion criteria will be recruited for this study which will be conducted at up to two sites within the USA. The participants will be followed for 1 s. Participants will be assessed using the Numeric Pain Rating Scale (NPRS), Knee Injury and Osteoarthritis Outcome Score (KOOS), 36-item short form survey (SF-36), Single Assessment Numeric Evaluation (SANE), physical exams, plain radiography, and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score for improvements in pain, satisfaction, function, and cartilage regeneration.
DISCUSSION
This prospective study will contribute to the limited amount of data on UC-derived WJ, particularly with regard to its safety and efficacy. The outcomes from this study will also lay the groundwork for a large placebo-controlled trial of intraarticular UC-derived WJ for symptomatic knee OA.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04719793 . Registered on 22 January 2021.
背景
骨关节炎（OA）是美国最常见的关节疾病，其中膝关节OA的患病率最高。炎症和血管化减少是关节软骨退变以及相关疼痛和功能减退的关键因素。为对抗这一过程，包括脐带华通氏胶（UC来源的WJ）在内的生物制剂的使用有所增加。UC来源的WJ含有大量再生因子，包括生长因子（GFs）、细胞因子（CKs）、透明质酸（HA）和细胞外囊泡（EVs）。拟进行的这项研究评估关节内注射UC来源的WJ治疗膝关节OA症状的安全性和有效性。
方法与分析
这是一项非随机、开放标签、多中心的前瞻性研究，将评估关节内注射UC来源的WJ对II/III级OA患者的安全性和有效性。将招募12名符合纳入和排除标准的II/III级OA患者参与本研究，研究将在美国境内最多两个地点进行。参与者将被随访1年。将使用数字疼痛评分量表（NPRS）、膝关节损伤和骨关节炎结局评分（KOOS）、36项简明健康调查（SF - 36）、单项评估数字评价（SANE）、体格检查、X线平片以及软骨修复组织磁共振观察（MOCART）评分对参与者进行评估，以观察疼痛、满意度、功能和软骨再生方面的改善情况。
讨论
这项前瞻性研究将为关于UC来源的WJ的有限数据做出贡献，特别是在其安全性和有效性方面。本研究的结果也将为一项关于关节内注射UC来源的WJ治疗有症状膝关节OA的大型安慰剂对照试验奠定基础。
试验注册
ClinicalTrials.gov NCT04719793。于2021年1月22日注册。
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