Research and Development Department, EMO Biomedicine Corporation, New Taipei City, Taiwan.
Department of Chemical Engineering, National United University, Miaoli City, Taiwan.
Cytotherapy. 2022 Jan;24(1):72-85. doi: 10.1016/j.jcyt.2021.08.006. Epub 2021 Oct 22.
Infrapatellar fat pad-derived mesenchymal stromal cells (IFP-MSCs) have not yet been used in a human clinical trial. In this open-label phase 1 study, patients with knee osteoarthritis (OA) received a single intra-articular injection of autologous IFP-MSCs. Safety was assessed through physical examination of the knee joint, vital signs, laboratory tests and adverse events. Efficacy was evaluated with regard to pain and function using questionnaires, x-ray and magnetic resonance imaging (MRI). Indoleamine-2,3-dioxygenase (IDO) expression in IFP-MSCs primed with interferon gamma was used as an in vitro potency measurement in investigating the correlations of clinical outcomes.
Twelve patients with symptomatic knee OA were recruited. IFP adipose tissue was harvested from each patient's knee through surgical excision for IFP-MSC manufacturing. Cryopreserved IFP-MSCs (5 × 10 cells) were injected into the knee joint immediately after thawing.
No significant adverse events were observed. Patients who received IFP-MSCs exhibited clinically significant pain and functional improvement at 48-week follow-up. The MRI Osteoarthritis Knee Score average was also significantly reduced from 100.2 before injection to 85.0 at 48 weeks after injection. The IDO expression of the primed IFP-MSCs of the 12 patients was correlated with clinical outcomes after injection.
A single intra-articular injection of IFP-MSCs appears to be a safe therapy for treating knee OA and may improve disease symptoms. IDO measurement of primed IFP-MSCs has potential as a potency marker of MSC products for immunomodulatory therapy.
髌下脂肪垫来源的间充质基质细胞（IFP-MSCs）尚未在人体临床试验中使用。在这项开放标签的 1 期研究中，膝骨关节炎（OA）患者接受了单次关节内注射自体 IFP-MSCs。通过膝关节体格检查、生命体征、实验室检查和不良事件评估安全性。使用问卷、X 射线和磁共振成像（MRI）评估疼痛和功能来评估疗效。用干扰素 γ预刺激的 IFP-MSCs 中的吲哚胺 2,3-双加氧酶（IDO）表达作为体外效力测量，以研究临床结果的相关性。
招募了 12 名有症状的膝 OA 患者。从每位患者的膝关节通过手术切除收集 IFP 脂肪组织，用于 IFP-MSC 制造。解冻后立即将冷冻保存的 IFP-MSCs（5×10 个细胞）注射到膝关节中。
未观察到明显的不良事件。接受 IFP-MSCs 治疗的患者在 48 周随访时表现出明显的临床疼痛和功能改善。注射前 MRI 骨关节炎膝关节评分平均值为 100.2，注射后 48 周时降至 85.0。12 名患者的预刺激 IFP-MSCs 的 IDO 表达与注射后临床结果相关。
单次关节内注射 IFP-MSCs 似乎是治疗膝 OA 的安全疗法，可改善疾病症状。预刺激 IFP-MSCs 的 IDO 测量可能是免疫调节治疗中 MSC 产品效力标志物的潜力。
