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Main
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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. |
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Register:
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ChiCTR |
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Last refreshed on:
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29 January 2018 |
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Main ID: |
ChiCTR1800014623 |
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Date of registration:
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2018-01-24 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren Syndrome
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Scientific title:
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A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren Syndrome |
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Date of first enrolment:
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2018-02-01 |
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Target sample size:
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stem cell group:20;hydroxychloroquine group:20; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=24947 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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New Treatment Measure Clinical Study
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Countries of recruitment
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China
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Contacts
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Name:
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Jianping Tang
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Address:
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389 Xincun Road, Putuo District, Shanghai, China
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Telephone:
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+86 18964869005 |
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Email:
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tangjp6512@126.com |
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Affiliation:
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Tongji Hospital of Tongji University |
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Name:
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Xuan Wang
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Address:
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389 Xincun Road, Putuo District, Shanghai, China
200065
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Telephone:
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+86 13918745569 |
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Email:
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baroquewang@icloud.com |
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Affiliation:
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Tongji Hospital of Tongji University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Sjogren Syndrome
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Intervention(s)
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stem cell group: Intravenous use mesenchymal stem cell ;hydroxychloroquine group:oral use hydroxychloroquine ;
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Primary Outcome(s)
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ESSDAI;immunoglobulin;complement;thrombocyte;leukocyte;pulmonary CT;salivary flow rate;
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Secondary Outcome(s)
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antinuclear antibodies;
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Source(s) of Monetary Support
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Fund of Tongji hospital
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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