中国组织工程研究

中国组织工程研究 ›› 2017, Vol. 21 ›› Issue (33): 5388-5393.doi: 10.3969/j.issn.2095-4344.2017.33.022

• 干细胞移植 stem cell transplantation • 上一篇    下一篇

局部应用富集单个核细胞、富血小板血浆和唑来膦酸防治早期股骨头骨坏死塌陷：前瞻性、随机、平行、对照临床试验研究方案

马 宁，王洪霞，卢 强，陈 思，万一群，刘莺莺，王 鑫，彭 江，郭全义   

  1. 解放军总医院骨科研究所，北京市  100853
  • 修回日期:2017-09-02 出版日期:2017-11-28 发布日期:2017-12-01
  • 通讯作者: 彭江，解放军总医院骨科研究所，北京市 100853
  • 作者简介:马宁，男，1981年生，内蒙古自治区人，满族，2011年大连医科大学毕业，硕士，主治医师，主要从事组织工程软骨及股骨头坏死早期保髋治疗。
  • 基金资助:

    国家自然科学基金(81572148)；北京市科技专项(Z161100005016059)；国家重点研发计划(2017YFC1104100)；解放军总医院转化基金(2016TM-015)；北京自然科学基金(7172203)；解放军总医院临床扶持基金(2017FC-TSYS-2007)

Local administration of mononuclear cell, platelet-rich plasma and zoledronic acid for the prevention and treatment of early femoral head osteonecrosis and collapse: study protocol for a prospective, randomized, parallel, controlled clinical trial

Ma Ning, Wang Hong-xia, Lu Qiang, Chen Si, Wan Yi-qun, Liu Ying-ying, Wang Xin, Peng Jiang, Guo Quan-yi   

  1. Institute of Orthopedics, Chinese PLA General Hospital, Beijing 100853, China
  • Revised:2017-09-02 Online:2017-11-28 Published:2017-12-01
  • Contact: Peng Jiang, Institute of Orthopedics, Chinese PLA General Hospital, Beijing 100853, China
  • About author:Ma Ning, Master, Attending physician, Institute of Orthopedics, Chinese PLA General Hospital, Beijing 100853, China
  • Supported by:

    the Scientific and Technological Project of Beijing, No. Z161100005016059; the National Natural Science Foundation of China, No. 81572148; the National Key Development and Research Program of China, No. 2017YFC1104100; the Translational Foundation of Chinese PLA Hospital, No. 2016TM-015; the Natural Science Foundation of Beijing, No. 7172203; the Clinical Supporting Foundation of Chinese PLA General Hospital, No. 2017FC-TSYS-2007

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摘要：

文章快速阅读：

文题释义：
单个核细胞：外周血单个核细胞是外周血中具有单个核的细胞，包括淋巴细胞和单核细胞。
富血小板血浆：是自体全血经离心后得到的血小板浓缩物，其含有大量生长因子及蛋白质。

 

摘要
背景：目前股骨头坏死的治疗方法很多，但保守治疗常常无效，因为股骨头一旦发生塌陷，其进展是不可逆的。课题组以往动物研究证实，局部唑来膦酸给药可预防股骨头坏死塌陷。骨髓单个核细胞治疗股骨头坏死有较好的短期临床效果。
目的：观察局部应用富集单个核细胞、富血小板血浆和唑来膦酸防治早期股骨头骨坏死塌陷的效果。
方法：试验为前瞻性、随机、平行对照、单中心临床试验。将在中国人民解放军总医院完成。试验将符合纳入标准的股骨头坏死Ficat Ⅰ-Ⅱ期患者100例随机等分为治疗组和对照组。治疗组：钻孔减压股骨头坏死区后先将含有骨髓单个核细胞的富血小板血浆通过专用加压注射器注入坏死股骨头，然后再将注射用唑来膦酸注射到坏死股骨头内；对照组：仅进行股骨头坏死区的钻孔减压。将在术后4，8，12，18个月随访，以髋关节动态灌注MR、髋关节CT三维重建及髋关节正侧位X射线片观察的股骨头坏死区血供、成骨及股骨头外观，髋关节Harris评分和数字疼痛强度量表评分评估的髋关节功能和疼痛情况为主要结局指标；SF-36生活质量评分和日常生活能力评分为次要结局指标。
讨论：试验方案的阳性成果将为临床局部联合应用含有单个核细胞的富血小板血浆和唑来膦酸，防治早期股骨头骨坏死塌陷提供量化数据。研究方案取得中国人民解放军总医院伦理委员会的书面批准(批准号：伦审第S2015-082-01)。研究者或研究者授权的人员负责向每名患者及法定监护人、家属解释参加研究的受益及风险，并取得书面的知情同意。研究符合世界医学会制订的《赫尔辛基宣言》。试验将于2015年1月至2017年12月在中国人民解放军总医院完成。文章结果将以科学会议报告，或在同行评议的期刊上发表传播。试验方案已在北美临床试验注册中心注册(NCT02721940)，目前正在进行患者招募。

 

关键词: 干细胞, 移植, 临床试验, 股骨头骨坏死, 股骨头塌陷, 局部治疗, 富集骨髓单个核细胞, 富血小板血浆, 唑来膦酸, 随机对照试验, 国家自然科学基金

Abstract:

BACKGROUND: There are various treatment methods for osteonecrosis of the femoral head (ONFH) and collapse, but conservative treatment is invalid. Once femoral head collapse occurs, the development is irreversible. Our previous research has shown that local administration of zoledronic acid can prevent necrotic femoral head collapse. Moreover, bone marrow mononuclear cells obtain satisfactory short-term efficacy in the treatment of ONFH.
OBJECTIVE: To investigate the curative efficacy of local administration of mononuclear cell, platelet-rich plasma and zoledronic acid for the prevention and treatment of early ONFH and collapse.
METHODS: This prospective, single-center, randomized, parallel, controlled clinical trial was conducted at the Chinese PLA General Hospital, Beijing, China. One hundred patients with ONFH (stages I-II by Ficat and Arlet classification) were enrolled and randomly assigned into either the treatment group or control group (n=50 per group). Patients were given an injection of mononuclear cell, platelet-rich plasma and zoledronic acid into the necrotic femoral head, or drilling decompression at the necrotic area. Patients in both groups were then followed up for 4, 8, 12, and 18 months. The primary outcome measures were the blood supply, osteogenesis and appearance of the necrotic femoral head observed on hip perfusion by dynamic MRI, CT restruction of the hip joint and radiography of the hip joint, as well as Harris hip scores and numerical rating scale scores. Secondary outcome measures included SF-36 Health Survey and Activities of Daily Living scores. 
DISCUSSION: The outcomes of this trial have provided quantitative data for analyzing the effectiveness of local administration of mononuclear cell, platelet-rich plasma and zoledronic acid on ONFH and collapse. Written approval for this protocol was obtained from the Ethics Committee of the Chinese PLA General Hospital in China (approval No. S2015-082-01). Participants and their families are informed of the study protocol and procedures, and signed an informed consent. The study was in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Trial began in January 2015 and will be completed in December 2017. Trial results will be published in scientific reports, or in peer-reviewed journals. This trial was registered with the ClinicalTrials.gov identifier: NCT02721940. Patient recruitment is ongoing.

 

Key words: Tissue Engineering, Femur Head Necrosis, Femur

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