Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Department of Life Science Engineering, Faculty of New Sciences and Technologies, University of Tehran, Tehran, Iran.
Connect Tissue Res. 2022 Nov;63(6):663-674. doi: 10.1080/03008207.2022.2074841. Epub 2022 Jul 20.
Mesenchymal stromal cells (MSCs) injection has been proposed as an innovative treatment for knee osteoarthritis (KOA). Since, allogeneic MSCs can be available as off-the-shelf products, they are preferable in regenerative medicine. Among different sources for MSCs, adipose-derived MSCs (AD-MSCs) appear to be more available.
Three patients with KOA were enrolled in this study. A total number of 100 × 10 AD-MSCs was injected intra-articularly, per affected knee. They were followed up for 6 months by the assessment of clinical outcomes, magnetic resonance imaging (MRI), and serum inflammatory biomarkers.
The primary outcome of this study was safety and feasibility of allogeneic AD-MSCs injection during the 6 months follow-up. Fortunately, no serious adverse events (SAEs) were reported. Assessment of secondary outcomes of visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and knee osteoarthritis outcome score (KOOS) indicated improvement in all patients. Comparison between baseline and endpoint findings of MRI demonstrated a slight improvement in two patients. In addition, decrease in serum cartilage oligomeric matrix protein (COMP) and hyaluronic acid (HA) indicated the possibility of reduced cartilage degeneration. Moreover, quantification of serum interleukin-10 (IL-10) and interleukin-6 (IL-6) levels indicated that the host immune system immunomodulated after infusion of AD-MSCs.
Intra-articular injection of AD-MSCs is safe and could be effective in cartilage regeneration in KOA. Preliminary assessment after six-month follow-up suggests the potential efficacy of this intervention which would need to be confirmed in randomized controlled trials on a larger population.
This study was registered in the Iranian registry of clinical trials (https://en.irct.ir/trial/46) in 24 April 2018 with identifier IRCT20080728001031N23.
间充质基质细胞（MSCs）注射已被提议作为治疗膝骨关节炎（KOA）的一种创新方法。由于同种异体 MSCs 可作为现成产品使用，因此在再生医学中更可取。在 MSCs 的不同来源中，脂肪来源的 MSCs（AD-MSCs）似乎更容易获得。
本研究纳入了 3 名 KOA 患者。每个受影响的膝关节关节内注射 100×10 个 AD-MSCs。通过临床结果、磁共振成像（MRI）和血清炎症生物标志物评估，对患者进行 6 个月的随访。
本研究的主要终点是在 6 个月的随访期间评估同种异体 AD-MSCs 注射的安全性和可行性。幸运的是，没有报告严重不良事件（SAEs）。所有患者的视觉模拟量表（VAS）、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）和膝关节骨关节炎结局评分（KOOS）的次要终点评估均表明有所改善。与基线和终点 MRI 发现相比，两名患者的结果有轻微改善。此外，血清软骨寡聚基质蛋白（COMP）和透明质酸（HA）的降低表明软骨退化程度降低。此外，血清白细胞介素-10（IL-10）和白细胞介素-6（IL-6）水平的定量分析表明，AD-MSCs 输注后宿主免疫系统的免疫调节作用。
关节内注射 AD-MSCs 是安全的，并且可能对 KOA 中的软骨再生有效。6 个月随访后的初步评估表明，这种干预措施具有潜在的疗效，需要在更大的人群中进行随机对照试验来证实。
本研究于 2018 年 4 月 24 日在伊朗临床试验注册处（https://en.irct.ir/trial/46）注册，标识符为 IRCT20080728001031N23。
