Vega Aurelio, Martín-Ferrero Miguel Angel, Del Canto Francisco, Alberca Mercedes, García Veronica, Munar Anna, Orozco Lluis, Soler Robert, Fuertes Juan Jose, Huguet Marina, Sánchez Ana, García-Sancho Javier
1 Servicio de Traumatología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 2 Instituto de Biología y Genética Molecular (IBGM), University of Valladolid and CSIC, Valladolid, Spain. 3 Institut de Teràpia Regenerativa Tissular (ITRT), Hospital Quirón Teknon, Barcelona, Spain. 4 Servicio de Radiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 5 Department of Magnetic Resonance Imaging, CETIR Clínica del Pilar, Barcelona, Spain.
Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678.
Osteoarthritis is the most prevalent joint disease and a common cause of joint pain, functional loss, and disability. Conventional treatments demonstrate only modest clinical benefits without lesion reversal. Autologous mesenchymal stromal cell (MSC) treatments have shown feasibility, safety, and strong indications for clinical efficacy. We performed a randomized, active control trial to assess the feasibility and safety of treating osteoarthritis with allogeneic MSCs, and we obtain information regarding the efficacy of this treatment.
We randomized 30 patients with chronic knee pain unresponsive to conservative treatments and showing radiological evidence of osteoarthritis into 2 groups of 15 patients. The test group was treated with allogeneic bone marrow MSCs by intra-articular injection of 40 × 10(6) cells. The control group received intra-articular hyaluronic acid (60 mg, single dose). Clinical outcomes were followed for 1 year and included evaluations of pain, disability, and quality of life. Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping.
Feasibility and safety were confirmed and indications of clinical efficacy were identified. The MSC-treated patients displayed significant improvement in algofunctional indices versus the active controls treated with hyaluronic acid. Quantification of cartilage quality by T2 relaxation measurements showed a significant decrease in poor cartilage areas, with cartilage quality improvements in MSC-treated patients.
Allogeneic MSC therapy may be a valid alternative for the treatment of chronic knee osteoarthritis that is more logistically convenient than autologous MSC treatment. The intervention is simple, does not require surgery, provides pain relief, and significantly improves cartilage quality.
骨关节炎是最常见的关节疾病,也是关节疼痛、功能丧失和残疾的常见原因。传统治疗方法仅显示出有限的临床益处,无法逆转病变。自体间充质基质细胞(MSC)治疗已显示出可行性、安全性及显著的临床疗效迹象。我们进行了一项随机、活性对照试验,以评估同种异体MSC治疗骨关节炎的可行性和安全性,并获取有关该治疗疗效的信息。
我们将30例对保守治疗无反应且有骨关节炎放射学证据的慢性膝关节疼痛患者随机分为两组,每组15例。试验组通过关节内注射40×10⁶个细胞接受同种异体骨髓MSC治疗。对照组接受关节内注射透明质酸(60mg,单剂量)。随访临床结果1年,包括疼痛、残疾和生活质量评估。通过定量磁共振成像T2映射评估关节软骨质量。
证实了可行性和安全性,并确定了临床疗效迹象。与接受透明质酸治疗的活性对照组相比,接受MSC治疗的患者在疼痛功能指标方面有显著改善。通过T2弛豫测量对软骨质量进行定量分析显示,软骨质量差的区域显著减少,接受MSC治疗的患者软骨质量有所改善。
同种异体MSC治疗可能是治疗慢性膝关节骨关节炎的一种有效替代方法,在后勤方面比自体MSC治疗更方便。该干预措施简单,无需手术,可缓解疼痛,并显著改善软骨质量。