ChiCTR-OPC-14005353 版本V1.0 版本创建时间2015/07/16 19:00:44 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-OPC-14005353 

最近更新日期：

Date of Last Refreshed on：

 2014-10-26 21:53:16 

注册时间：

Date of Registration：

 2014-09-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

臨床試驗研究 –「自體間質幹細胞治療腕關節軟骨缺損」

Public title：

A pilot "SCIATICA" study - Stem Cell Intra-Articular Therapeutic Injection for Carpal Affections

注册题目简写：

A pilot

English Acronym：

A pilot "SCIATICA" study

研究课题的正式科学名称：

臨床試驗研究 –「自體間質幹細胞治療腕關節軟骨缺損」

Scientific title：

A pilot "SCIATICA" study - Stem Cell Intra-Articular Therapeutic Injection for Carpal Affections

研究课题代号(代码)：

Study subject ID：

 CREC 2014.291-T

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：

CUHK_CCT00433

申请注册联系人：

JoJo Kwok 

研究负责人：

Dr WL Tse 

Applicant：

JoJo Kwok 

Study leader：

Dr WL Tse 

申请注册联系人电话：

Applicant telephone：

 +852 26326553

研究负责人电话：

Study leader's
telephone：

+852 26322065

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：

 jojokwok@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 tse@ort.cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00433

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00433

申请注册联系人通讯地址：

Department of Orthopaedics and Traumatoloy, Prince of Wales Hospital, Shatin, Hong Kong

研究负责人通讯地址：

Department of Orthopaedics and Traumatoloy, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT Hong Kong, SAR

Applicant address：

Department of Orthopaedics and Traumatoloy, Prince of Wales Hospital, Shatin, Hong Kong

Study leader's address：

Department of Orthopaedics and Traumatoloy, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT Hong Kong, SAR

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：

Department of Orthopaedics and Traumatoloy, Prince of Wales Hospital, Shatin, Hong Kong

Applicant's institution：

Department of Orthopaedics and Traumatoloy, Prince of Wales Hospital, Shatin, Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

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：

 Nil

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

The Chinese University of Hong Kong, Prince of Wales Hospital

Name of the ethic committee：

The Chinese University of Hong Kong, Prince of Wales Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2014-08-05 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

Dr. WL Tse

Primary sponsor：

Dr. WL Tse

研究实施负责（组长）单位地址：

Department of Orthopaedics and Traumatoloy, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT Hong Kong, SAR

Primary sponsor's address：

Department of Orthopaedics and Traumatoloy, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT Hong Kong, SAR

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

Province：

City：

单位(医院)：

具体地址：

Institution
hospital：

Dr. PC Ho

Address：

经费或物资来源：

The Chinese University of Hong Kong

Source(s) of funding：

The Chinese University of Hong Kong

研究疾病：

Patients with post-traumatic chronic wrist pain, with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects who opt for active treatment  

Target disease：

Patients with post-traumatic chronic wrist pain, with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects who opt for active treatment

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

Therapeutic wrist arthroscopy and bone marrow aspiration will be performed. Therapeutic wrist arthroscopy is done to remove the cartilage defect and bone marrow aspiration is done to collect your bone marrow blood for cultivation and expansion of autologous mesenchymal stem cells. One month after arthroscopic debridement, autologous stems cells obtained from purification and expansion of your bone marrow cells will be injected into the affected joint to stimulate the regeneration of cartilage.  

Objectives of Study：

Therapeutic wrist arthroscopy and bone marrow aspiration will be performed. Therapeutic wrist arthroscopy is done to remove the cartilage defect and bone marrow aspiration is done to collect your bone marrow blood for cultivation and expansion of autologous mesenchymal stem cells. One month after arthroscopic debridement, autologous stems cells obtained from purification and expansion of your bone marrow cells will be injected into the affected joint to stimulate the regeneration of cartilage.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Wrist pain of mechanical origin(post-traumatic);
2. The pain cannot be relieved by treating other underlying defects other than carpal affections;
3. Patients with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects;
4. Absence of any local or general infection;
5. Hematologic and biochemical analyses with no significant alterations that contraindicate intervention;
6. Patient who is able to understand the nature the study and provide informed written consent.

Inclusion criteria

1. Wrist pain of mechanical origin(post-traumatic);
2. The pain cannot be relieved by treating other underlying defects other than carpal affections;
3. Patients with imaging and previous arthroscopic evidence of wrist carpal bone chondral defects;
4. Absence of any local or general infection;
5. Hematologic and biochemical analyses with no significant alterations that contraindicate intervention;
6. Patient who is able to understand the nature the study and provide informed written consent.

排除标准：

1. Age older than 75 or younger than 18 years old or legally dependent;
2. Patients with past history of hematologic disorders;
3. Signs of infection or positive serology for HIV, HBV, HCV, or syphilis;
4. Congenital or acquired diseases leading to significant wrist deformities that may interfere with cell application or interpretation of results;
5. Pregnancy or breast, feeding, Neoplasia, Immunosuppression, Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study;
6. Patients with alcoholism/drug abuse;
7. Other medical conditions that may discourage participation in the study.

Exclusion criteria：

1. Age older than 75 or younger than 18 years old or legally dependent;
2. Patients with past history of hematologic disorders;
3. Signs of infection or positive serology for HIV, HBV, HCV, or syphilis;
4. Congenital or acquired diseases leading to significant wrist deformities that may interfere with cell application or interpretation of results;
5. Pregnancy or breast, feeding, Neoplasia, Immunosuppression, Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study;
6. Patients with alcoholism/drug abuse;
7. Other medical conditions that may discourage participation in the study.

研究实施时间：

Study execute time：

从 From 2014-10-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2014-10-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 20

Group：

Case series

Sample size：

干预措施：

Autologous mesenchymal stem cell intra-articular injection

干预措施代码：

Intervention：

Autologous mesenchymal stem cell intra-articular injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 中國香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Chinese University of Hong Kong 

单位级别：

 Chinese University of Hong Kong 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Diagnostic radiological (MRI)assessments will be done at post-injection 6th month.

指标类型：

主要指标

Outcome：

Diagnostic radiological (MRI)assessments will be done at post-injection 6th month.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

VAS, functional wrist score, PRWE, DASH, Power, ROM at post-injection 3rd, 6th, 12nd and 24th month

指标类型：

次要指标

Outcome：

VAS, functional wrist score, PRWE, DASH, Power, ROM at post-injection 3rd, 6th, 12nd and 24th month

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

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 岁 years
最大 Max age 75 岁 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）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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)：

是否共享原始数据：

IPD sharing

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）：

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

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：

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2014-10-20 16:11:15