Centeno-Schultz Clinic, Broomfield, Colorado, USA.
Curr Stem Cell Res Ther. 2010 Mar;5(1):81-93. doi: 10.2174/157488810790442796.
ABSTRUCT: Mesenchymal stem cells (MSCs) hold great promise as therapeutic agents in regenerative medicine. Numerous animal studies have documented the multipotency of MSCs, showing their capabilities for differentiating into orthopedic tissues such as muscle, bone, cartilage, and tendon. However, the complication rate for autologous MSC therapy is only now beginning to be reported.
Between 2005 and 2009, two groups of patients were treated for various orthopedic conditions with culture-expanded, autologous, bone marrow-derived MSCs (group 1: n=45; group 2: n=182). Cells were cultured in monolayer culture flasks using an autologous platelet lysate technique and re-injected into peripheral joints (n=213) or into intervertebral discs (n=13) with use of c-arm fluoroscopy. While both groups had prospective surveillance for complications, Group 1 additionally underwent 3.0T MRI tracking of the re-implant sites.
Mean follow-up from the time of the re-implant procedure was 10.6 +/- 7.3 months. Serial MRI's at 3 months, 6 months, 1 year and 2 years failed to demonstrate any tumor formation at the re-implant sites. Formal disease surveillance for adverse events based on HHS criteria documented 7 cases of probable procedure-related complications (thought to be associated with the re-implant procedure itself) and three cases of possible stem cell complications, all of which were either self-limited or were remedied with simple therapeutic measures. One patient was diagnosed with cancer; however, this was almost certainly unrelated to the MSC therapy.
Using both high field MRI tracking and general surveillance in 227 patients, no neoplastic complications were detected at any stem cell re-implantation site. These findings are consistent with other reports that also show no evidence of malignant transformation in vivo, following implantation of MSCs that were expanded in vitro for limited periods.
摘要：间充质干细胞（MSCs）作为再生医学中的治疗剂具有巨大的潜力。许多动物研究记录了 MSCs 的多能性，显示了它们分化为骨科组织（如肌肉、骨骼、软骨和肌腱）的能力。然而，自体 MSC 治疗的并发症发生率现在才开始报道。
在 2005 年至 2009 年间，两组患者因各种骨科疾病接受了培养的自体骨髓源性 MSCs（第 1 组：n=45；第 2 组：n=182）治疗。使用自体血小板裂解液技术，在单层培养瓶中培养细胞，并通过 C 臂荧光透视术将细胞重新注入外周关节（n=213）或椎间盘（n=13）。虽然两组均对并发症进行了前瞻性监测，但第 1 组还对再植入部位进行了 3.0T MRI 跟踪。
从再植入手术时间开始的平均随访时间为 10.6±7.3 个月。3 个月、6 个月、1 年和 2 年的连续 MRI 检查均未在再植入部位发现任何肿瘤形成。根据 HHS 标准对不良事件进行的正式疾病监测记录了 7 例可能与手术相关的并发症（认为与再植入手术本身有关）和 3 例可能与干细胞相关的并发症，所有这些并发症要么是自限性的，要么通过简单的治疗措施得到纠正。一名患者被诊断为癌症；然而，这几乎可以肯定与 MSC 治疗无关。
在 227 名患者中，使用高场 MRI 跟踪和一般监测均未在任何干细胞再植入部位检测到肿瘤并发症。这些发现与其他报告一致，即在体外有限时间内扩增的 MSCs 植入后，体内没有恶性转化的证据。
