Efficacy of a single dose of cryopreserved human umbilical cord mesenchymal stromal cells for the treatment of knee osteoarthritis:a randomized, controlled, double-blind pilot study.

IF 3.7 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Cytotherapy Pub Date : 2024-10-16 DOI:10.1016/j.jcyt.2024.09.005

Omar Amado Pico, Francisco Espinoza, María Ignacia Cádiz, Claudia L Sossa, Silvia M Becerra-Bayona, María C Canencio Salgado, Javier Eduardo Rengifo Rodríguez, Oscar Fabian Valdivieso Cárdenas, Johanna Marcela Quintero Cure, Maroun Khoury, Martha L Arango-Rodríguez

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引用次数: 0

Abstract

Background: 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.

Aim: 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 × 10⁶ ± 5 × 10⁵ UC-MSCs), vs. triamcinolone (a synthetic corticosteroid) (10 mg/mL) in thirty patients with symptomatic knee OA (Kellgren-Lawrence grade II or III).

Methods: 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.

Results: 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).

Conclusions: 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.

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单剂量低温保存的人脐带间充质基质细胞治疗膝骨关节炎的疗效：一项随机、对照、双盲试验研究。

背景：膝关节骨关节炎（OA）是最普遍的退行性肌肉骨骼疾病，在老年人群中尤为常见。虽然传统治疗方法效果有限，但有必要开发更有效的治疗策略，以解决这一主要的疼痛和残疾问题。脐带间充质干细胞（UC-MSCs）为治疗膝关节 OA 提供了一种很有前景的治疗方法。目的：本项随机、前瞻性、双盲对照试验研究旨在评估和比较单次关节内注射标准化产品 CellistemOA（5 × 106 ± 5 × 105 UC-MSCs）与曲安奈德（一种合成药物）的安全性和疗效。方法：对30名有症状的膝关节OA（凯尔格伦-劳伦斯II级或III级）患者进行三苯氧胺（一种合成皮质类固醇）（10毫克/毫升）单次关节内注射：方法：研究结果包括西安大略和麦克马斯特大学骨关节炎指数（WOMAC）基于李克特量表的评分、疼痛数字评分（NRS）、磁共振成像（MRI）和生活质量（SF-36问卷）从基线到12个月随访期间的变化：结果：与曲安奈德组相比，使用 CellistemOA 治疗的患者从基线到 12 个月期间的 WOMAC 评分（包括三个分量表评分（疼痛、僵硬和功能））、疼痛 NRS 和 SF-36 资料均有显著改善（P < 0.05），且无严重不良反应报告。两组患者的 MRI WORMS 评分无明显差异。然而，接受细胞治疗的患者的 SF-36 资料有了明显改善（p < 0.05）：这项试验性研究表明，单剂量 CellistemOA 对膝关节 OA 的治疗是安全的，并且在 1 年的随访中优于活性比较药，因此它是治疗有症状的 OA 患者的一种令人信服的替代疗法。

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来源期刊

Cytotherapy 医学-生物工程与应用微生物

CiteScore

6.30

自引率

4.40%

发文量

683

审稿时长

49 days

期刊介绍： The journal brings readers the latest developments in the fast moving field of cellular therapy in man. This includes cell therapy for cancer, immune disorders, inherited diseases, tissue repair and regenerative medicine. The journal covers the science, translational development and treatment with variety of cell types including hematopoietic stem cells, immune cells (dendritic cells, NK, cells, T cells, antigen presenting cells) mesenchymal stromal cells, adipose cells, nerve, muscle, vascular and endothelial cells, and induced pluripotential stem cells. We also welcome manuscripts on subcellular derivatives such as exosomes. A specific focus is on translational research that brings cell therapy to the clinic. Cytotherapy publishes original papers, reviews, position papers editorials, commentaries and letters to the editor. We welcome "Protocols in Cytotherapy" bringing standard operating procedure for production specific cell types for clinical use within the reach of the readership.