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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 29 January 2018
Main ID:  ChiCTR1800014623
Date of registration: 2018-01-24
Prospective Registration: Yes
Primary sponsor: Tongji Hospital of Tongji University
Public title: A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren Syndrome
Scientific title: A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren Syndrome
Date of first enrolment: 2018-02-01
Target sample size: stem cell group:20;hydroxychloroquine group:20;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=24947
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: Xuan Wang   
Address:  389 Xincun Road, Putuo District, Shanghai, China 200065
Telephone: +86 13918745569
Email: baroquewang@icloud.com
Affiliation:  Tongji Hospital of Tongji University
Name: Jianping Tang   
Address:  389 Xincun Road, Putuo District, Shanghai, China
Telephone: +86 18964869005
Email: tangjp6512@126.com
Affiliation:  Tongji Hospital of Tongji University
Key inclusion & exclusion criteria
Inclusion criteria: (1) According to 2002 International Classification Standard for Sjogren syndrome;
(2) informed consent signed;approved by Ethics Committee of Tongji hospital;
(3) aged from 18 to 65 years old, male or female;
(4) ESSDAI=4.
At least 1 of the following 3 items:
(5) refractory immune Leukopenia or thrombocytopenia;
(6) interstitial lung disease;
(7) cannot be healed by conventional immunosuppressive therapy.

Exclusion criteria: (1) patient In remission;
(2) severe organ dysfunction(heart/lung/liver/kidney);
(3) combined with systemic infection or severe focal infection;
(4) a variety of drug allergies;
(5) breast-feeding and pregnant women.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Sjogren Syndrome
Intervention(s)
stem cell group: Intravenous use mesenchymal stem cell ;hydroxychloroquine group:oral use hydroxychloroquine ;
Primary Outcome(s)
ESSDAI;immunoglobulin;complement;thrombocyte;leukocyte;pulmonary CT;salivary flow rate;
Secondary Outcome(s)
antinuclear antibodies;
Secondary ID(s)
Source(s) of Monetary Support
Fund of Tongji hospital
Secondary Sponsor(s)
Ethics review
Status: Not approved
Approval date: 26/08/2013
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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