Pico Omar Amado, Espinoza Francisco, Cádiz María Ignacia, Sossa Claudia L, Becerra-Bayona Silvia M, Salgado María C Canencio, Rodríguez Javier Eduardo Rengifo, Cárdenas Oscar Fabian Valdivieso, Cure Johanna Marcela Quintero, Khoury Maroun, Arango-Rodríguez Martha L
Fundación Oftalmológica de Santander - FOSCAL, Floridablanca, Colombia; Facultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga - UNAB, Bucaramanga, Colombia.
Cells for Cells & Consorcio Regenero, Santiago, Chile; Program for Translational Research in Cell Therapy, Universidad de los Andes, Santiago, Chile; Department of Rheumatology, Universidad de los Andes, Santiago, Chile; IMPACT, Center of Interventional Medicine for Precision and Advanced Cellular Therapy, Santiago, Chile.
Cytotherapy. 2025 Feb;27(2):188-200. doi: 10.1016/j.jcyt.2024.09.005. Epub 2024 Oct 16.
Knee osteoarthritis (OA) is the most prevalent degenerative musculoskeletal disorder, which is particularly common in older population. While conventional treatments have limited effectiveness, the development of more effective therapeutic strategies is necessary to address this primary source of pain and disability. Umbilical cord mesenchymal stromal cells (UC-MSCs) offer a promising therapeutic approach for treating knee OA.
This randomized, prospective, double-blind and controlled pilot study was carried out to evaluate and compare the safety and therapeutic efficacy of a single intra-articular injection of a standardized product CellistemOA (5 × 10 ± 5 × 10 UC-MSCs), vs. triamcinolone (a synthetic corticosteroid) (10 mg/mL) in thirty patients with symptomatic knee OA (Kellgren-Lawrence grade II or III).
The outcomes included changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores based on a Likert scale, numerical rating score (NRS) for pain, Magnetic Resonance Imaging (MRI), and quality of life (SF-36 questionnaire), from baseline and throughout 12-months of follow-up.
Patients treated with CellistemOA showed significant improvement in WOMAC score (including the three subscale scores (pain, stiffness and function), NRS in pain, and SF-36 profile from baseline to 12 months (p < 0.05) compared to the triamcinolone group, and no severe adverse events were reported. There were no significant differences in MRI WORMS scores between the two groups. However, patients who received the cellular treatment experienced a significant improvement in their SF-36 profile (p < 0.05).
This pilot study revealed that a single dose of CellistemOA is safe and superior to the active comparator in knee OA at 1-year of follow-up, making it a compelling therapeutic alternative to treat symptomatic OA patients.
膝关节骨关节炎（OA）是最常见的退行性肌肉骨骼疾病，在老年人群中尤为普遍。虽然传统治疗效果有限，但开发更有效的治疗策略对于解决这种疼痛和残疾的主要根源是必要的。脐带间充质基质细胞（UC-MSCs）为治疗膝关节OA提供了一种有前景的治疗方法。
本随机、前瞻性、双盲对照试验性研究旨在评估和比较单次关节腔内注射标准化产品CellistemOA（5×10±5×10 UC-MSCs）与曲安奈德（一种合成皮质类固醇）（10 mg/mL）对30例有症状膝关节OA（Kellgren-Lawrence分级II或III级）患者的安全性和治疗效果。
观察指标包括基于李克特量表的西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分变化、疼痛数字评定量表（NRS）、磁共振成像（MRI）以及从基线到12个月随访期间的生活质量（SF-36问卷）。
与曲安奈德组相比，接受CellistemOA治疗的患者从基线到12个月时WOMAC评分（包括三个子量表评分（疼痛、僵硬和功能））以及疼痛NRS评分和SF-36量表均有显著改善（p<0.05），且未报告严重不良事件。两组间MRI WORMS评分无显著差异。然而，接受细胞治疗的患者SF-36量表有显著改善（p<0.05）。
这项试验性研究表明，单剂量CellistemOA在随访1年时对膝关节OA是安全的，且优于活性对照药，使其成为治疗有症状OA患者的一种有吸引力的治疗选择。
