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自体脂肪血管基质组分(SVF)治疗软骨缺损的 随机对照临床试验
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注册号:

Registration number:

ChiCTR1800015379 

最近更新日期:

Date of Last Refreshed on:

2018-03-28 

注册时间:

Date of Registration:

2018-03-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

自体脂肪血管基质组分(SVF)治疗软骨缺损的 随机对照临床试验 

Public title:

The Randomized Controlled Clinical Trial of Autologous Stromal Vascular Fraction in Cartilage Defect 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

髌下脂肪垫组织中血管基质成分(IPFP-SVF)治疗膝关节软骨病损临床试验 

Scientific title:

The Clinical Trial of Application of Infrapatella fatpad-Vascular Matrix Components (IPFP-SVF) to Treat Knee Articular Cartilage Injury 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

周义钦 

研究负责人:

钱齐荣 

Applicant:

Yiqin Zhou 

Study leader:

Qirong Qian 

申请注册联系人电话:

Applicant telephone:

+86 15721571090 

研究负责人电话:

Study leader's telephone:

+86 13818940205 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

drzhouyiqin@163.com 

研究负责人电子邮件:

Study leader's E-mail:

qianqr@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市凤阳路415号 

研究负责人通讯地址:

上海市凤阳路415号 

Applicant address:

415 Fengyang Road, Shanghai, China 

Study leader's address:

415 Fengyang Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海长征医院 

Applicant's institution:

Shanghai Changzheng Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

CZEC(2016)-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海长征医院医学伦理委员会 

Name of the ethic committee:

SHanghai Changezheng Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-04-21 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

中国上海市凤阳路415号 

Contact Address of the ethic committee:

415 Fengyang Road, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

上海长征医院 

Primary sponsor:

Shanghai Changzheng Hospital 

研究实施负责(组长)单位地址:

上海市凤阳路415号 

Primary sponsor's address:

415 Fengyang Road, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海长征医院

具体地址:

上海市凤阳路415号

Institution
hospital:

Shanghai Changzheng Hospital

Address:

415 Fengyang Road, Shanghai, China

经费或物资来源:

上海长征医院关节外科自主研究 

Source(s) of funding:

Independent Research by Joint Surgery and Sports Medicine Department, Shanghai Changzheng Hospital  

研究疾病:

膝关节软骨病损 

Target disease:

Knee articular cartilage injury 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

明确髌下脂肪垫组织中血管基质成分(IPFP-SVF)对膝关节软骨损伤的疗效 

Objectives of Study:

To research the efficacy of infrapatella fatpad-vascular matrix components (IPFP-SVF) on knee articular cartilage injury 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

① 年龄在18-75岁者; ② MRI明确提示关节软骨损伤,Kellgren-Lawrence标准膝骨关节炎3级及以下; ③ 膝关节有明显疼痛或不适症状,且持续时间超过3个月; ④ 签署知情同意书。 ⑤ 关节镜下曾明确关节软骨损伤诊断,未行针对性治疗处理的患者 

Inclusion criteria

1. Between the ages of 18 and 75; 2. MRI clearly indicated articular cartilage injury, Kellgren-Lawrence standard knee grade for OA was not more than level-3; 3. Obvious knee pain or discomfort symptoms and lasted for more than 3 months; 4. Signed the informed consent; 5. Diagnosed articular cartilage injury has by arthroscopy, and no targeted treatment had been made. 

排除标准:

① 已行其他关节软骨治疗性手术; ② 三月之内有关节内注射史或关节周围创伤性治疗史以及其他关节周围浸入式检查或治疗; ③ 症状及影像学表现均局限在髌股关节的患者; ④ 恶性肿瘤患者; ⑤ 机体其他部位有活跃的感染灶; ⑥ 妊娠或哺乳期妇女,或准备妊娠妇女; ⑦ 因感染性或者痛风性关节炎引起软骨病损; ⑧ 患类风湿性关节炎、强直性脊柱炎等自身免疫性疾病; ⑨ 患者患有糖尿病,空腹血糖大于8mmol/L,且控制不佳; ⑩ 一般情况较差,无法耐受手术者; ? 有脑出血、重症肺炎、多器官功能障碍等重症疾病; ? 患者或家属拒绝参加该研究; ? 夏柯氏关节; ? 研究中发现可能增加患者风险或影响实验结果的情况; ? 其它不适合加入该研究的原因。 

Exclusion criteria:

1. Other surgical procedures had been performed to treat articular cartilage; 2. A history of intra-articular injection or a history of peri-articular invasive treatments and procedures within three months; 3. Symptoms and imaging findings were localised in patellofemoral joint; 4. Patients with malignant neoplasms; 5. Active infection in other parts of the body; 6. Pregnant or lactating women or women preparing for pregnancy; 7. Cartilage lesions caused by infectious or gouty arthritis; 8. Autoimmune diseases such as rheumatoid arthritis and ankylosing spondylitis; 9. The patient had diabetes with FBG over 8mmol/ L and had poor control; 10. Patients who are generally in poor condition and cannot tolerate surgery; 11. Severe diseases such as cerebral hemorrhage, severe pneumonia and multiple organ dysfunction; 12. Refused by the patient or family to participate in the study; 13. Charcot joint; 15. Find something may increase the patient's risk or influence the results of the experiment during the research; 16. Other reasons not fit for this study. 

研究实施时间:

Study execute time:

From2018-04-01To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2018-04-01To 2018-12-31 

干预措施:

Interventions:

组别:

IPFP-SVF处理组

样本量:

30

Group:

IPFP-SVF treatment Group

Sample size:

干预措施:

IPFP-SVF处理

干预措施代码:

Intervention:

IPFP-SVF treatment

Intervention code:

组别:

对照组

样本量:

30

Group:

Control Group

Sample size:

干预措施:

生理盐水处理

干预措施代码:

Intervention:

Saline Treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

膝关节X线及K-L评级

指标类型:

主要指标 

Outcome:

Knee X ray and K-L rating

Type:

Primary indicator 

测量时间点:

术前,术后6月,术后12月

测量方法:

Measure time point of outcome:

Pre-op, Post-op 6M, Post-op 12M

Measure method:

指标中文名:

膝关节MRI及WORMS评分

指标类型:

主要指标 

Outcome:

Knee MRI and WORMS Score

Type:

Primary indicator 

测量时间点:

术前,术后6月,术后12月

测量方法:

Measure time point of outcome:

Pre-op, Post-op 6M, Post-op 12M

Measure method:

指标中文名:

膝关节功能评分(VAS评分,WOMAC评分)

指标类型:

主要指标 

Outcome:

Knee function score (VAS score, WOMAC score)

Type:

Primary indicator 

测量时间点:

术前,术后2天、3月、6月、12月

测量方法:

Measure time point of outcome:

Pre-op, Post-op 2d, Post-op 3M, Post-op 6M, Post-op 12M

Measure method:

指标中文名:

血常规,血沉,CRP

指标类型:

次要指标 

Outcome:

Blood RT, ESR, CRP

Type:

Secondary indicator 

测量时间点:

术前,术后2天、3月、6月、12月

测量方法:

Measure time point of outcome:

Pre-op, Post-op 2d, Post-op 3M, Post-op 6M, Post-op 12M

Measure method:

指标中文名:

肝肾功能

指标类型:

副作用指标 

Outcome:

Hepatic and renal function

Type:

Adverse events 

测量时间点:

术前,术后6月,术后12月

测量方法:

Measure time point of outcome:

Pre-op, Post-op 6M, Post-op 12M

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

使用计算机随机分组,具体方法为:使用计算机随机生成n个(n为各单位病例总数)1000以内的整数,标注序号,按大小对随机数进行排序,前、后n1、n2(为相应单位各组病例数)所对应的序号分别入组IPFP-SVF处理组、对照组.

Randomization Procedure (please state who generates the random number sequence and by what method):

Use computer to group randomly, the method is: using the computer to random generate n (n for the total number of cases per unit) within 1000 integers, label ordinal number, sort random numbers by size. The serial numbers of IPFP-SVF injection group, and blank group were compared with each other in&

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

临床研究公共管理平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Research Manager, ResMan

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-03-27
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