Piuzzi Nicolas S, Chahla Jorge, Jiandong Hao, Chughtai Morad, LaPrade Robert F, Mont Michael A, Muschler George F, Pascual-Garrido Cecilia
Department of Orthopaedic Surgery and Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio; Instituto Universitario del Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Steadman Philippon Research Institute, Vail, Colorado.
J Arthroplasty. 2017 Aug;32(8):2612-2618. doi: 10.1016/j.arth.2017.02.075. Epub 2017 Mar 15.
Osteonecrosis of the femoral head (ONFH) is associated with regional loss of cells within bone, often resulting in pain and mechanical collapse. Our purpose was to analyze the cell-therapies used in clinical trials for the treatment of ONFH with regard to (1) cell-sources, (2) collection techniques, (3) cell-processing, (4) qualitative and quantitative characterizations, and (5) delivery methods.
A systematic review of the current literature on the use of cell therapies for the treatment of ONFH was performed. Studies with a level-of-evidence III or higher were evaluated. A total of 1483 articles were screened. Eleven studies met the criteria to be included in this review.
Ten studies used bone-marrow, and 1 study used blood as the cell-source. Nine studies used freshly isolated tissue-derived nucleated cells from bone-marrow, mixed bone marrow-derived nucleated cells, 1 study used mixed blood-derived nucleated cells, and 1 study used culture-expanded cells derived from bone marrow aspirate. Cell dose varied from 2-million to 3-billion cells. Qualitative cell characterization of injected cells using surface markers was done by 5 studies using CD34. Two studies assayed the cell-population using a colony-forming-unit assay.
There is a lack of standardization with respect to the quantitative and qualitative characterization of methods for cell-harvest, cell-processing, and cell-transplantation/delivery. Cell-therapy holds promise as a means of restoring local cell populations that are made deficient because of injury or disease. However, the orthopedic community and patients will benefit greatly by a greater investment in blinded, randomized, controlled trials and clinical effectiveness trials that embrace rigorous standards.
股骨头坏死（ONFH）与骨内局部细胞缺失相关，常导致疼痛和机械性塌陷。我们的目的是分析用于治疗ONFH的临床试验中所使用的细胞疗法，涉及以下方面：（1）细胞来源；（2）采集技术；（3）细胞处理；（4）定性和定量特征；（5）递送方法。
对目前使用细胞疗法治疗ONFH的文献进行系统综述。对证据水平为III级或更高的研究进行评估。共筛选了1483篇文章。11项研究符合纳入本综述的标准。
10项研究使用骨髓，1项研究使用血液作为细胞来源。9项研究使用从骨髓中新鲜分离的组织来源有核细胞、混合骨髓来源有核细胞，1项研究使用混合血液来源有核细胞，1项研究使用从骨髓抽吸物中培养扩增的细胞。细胞剂量从200万到30亿个细胞不等。5项研究使用CD34对注射细胞进行基于表面标志物的定性细胞表征。2项研究使用集落形成单位试验分析细胞群体。
在细胞收获、细胞处理以及细胞移植/递送方法的定量和定性表征方面缺乏标准化。细胞疗法有望作为一种恢复因损伤或疾病而减少的局部细胞群体的手段。然而，通过对采用严格标准的盲法、随机、对照试验和临床有效性试验进行更多投入，骨科界和患者将受益匪浅。
