最新一项研究评估了同种异体脐带血间充质干细胞组成的新药物促进关节软骨再生的安全性和功效。研究者选取了Kellgren-Lawrence3级骨关节炎和ICRS4级软骨缺陷的患者，在患者病变的部位涂抹同种异体脐带干细胞和透明质酸水凝胶的复合物。在一个长达7年的随访中，他们评估了安全性、VAS（视觉模拟量表）评分、国际其关节文献委员会的主管评分、MRI结果以及组织学评价。结果显示，在参加实验的7名患者中，12周的关节镜检查时观察到成熟的修复组织，24周时VAS和IKDC评分得到改善。在7年的随访中，临床改善结果是稳定的。1年的组织学检查发现透明样软骨的生成，第3年的MRI 显示持续性的再生软骨。观察到仅5个轻度的中枢性治疗-紧急不良事件。7年内没有骨形成或肿瘤发生的病例。该新型基于干细胞的药物产品的应用对骨关节炎软骨的再生是安全和有效的。
干细胞的应用已经成为再生医学领域的主要研究方向。hUCB-MSC以非侵入性的方式取得，具有低免疫原性，并且具有高扩增能力，这为其应用于临床治疗提供了充足的细胞来源。hUCB-MSC和透明质酸水凝胶复合材料促进关节软骨再生为关节炎患者提供了一种安全有效的新型治疗途径，从根本上改善了关节炎患者的软骨缺陷，提升疗效的同时也降低了患者治疗过程中的痛苦和副作用。这是干细胞临床应用的新突破，为患有软骨缺陷的骨关节炎患者带来了曙光，干细胞促进软骨再生有望成为关节炎治疗的中坚力量。
推荐阅读原文：
Cartilage Regeneration in Osteoarthritic Patients by aComposite of Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cells andHyaluronate Hydrogel: Results from a Clinical Trial for Safety andProof-of-Concept with 7 Years of Extended Follow-Up
Few methods are available to regenerate articularcartilage defects in patients with osteoarthritis. We aimed to assess thesafety and efficacy of articular cartilage regeneration by a novel medicinalproduct composed of allogeneic human umbilical cord blood-derived mesenchymalstem cells (hUCB-MSCs). Patients with Kellgren-Lawrence grade 3 osteoarthritisand International Cartilage Repair Society (ICRS) grade 4 cartilage defectswere enrolled in this clinical trial. The stem cell-based medicinal product (acomposite of culture-expanded allogeneic hUCB-MSCs and hyaluronic acid hydrogel[Cartistem]) was applied to the lesion site. Safety was assessed by the WorldHealth Organization common toxicity criteria. The primary efficacy outcome wasICRS cartilage repair assessed by arthroscopy at 12 weeks. The secondaryefficacy outcome was visual analog scale (VAS) score for pain on walking.During a 7-year extended follow-up, we evaluated safety, VAS score, InternationalKnee Documentation Committee (IKDC) subjective score, magnetic resonanceimaging (MRI) findings, and histological evaluations. Seven participants wereenrolled. Maturing repair tissue was observed at the 12-week arthroscopicevaluation. The VAS and IKDC scores were improved at 24 weeks. The improvedclinical outcomes were stable over 7 years of follow-up. The histologicalfindings at 1 year showed hyaline-like cartilage. MRI at 3 years showedpersistence of the regenerated cartilage. Only five mild to moderatetreatment-emergent adverse events were observed. There were no cases ofosteogenesis or tumorigenesis over 7 years. The application of this novel stemcell-based medicinal product appears to be safe and effective for theregeneration of durable articular cartilage in osteoarthritic knees.
转自：中国干细胞集团
