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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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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03219801 |
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Date of registration:
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10/07/2017 |
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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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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus
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Scientific title:
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Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells |
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Date of first enrolment:
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August 1, 2017 |
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Target sample size:
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10 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03219801 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Early Phase 1
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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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Baoyong Yan, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Xianyun Wang, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Quanhai Li, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Qingchi Liu Liu, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Bing Ma, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Wanyi Yin, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Xiaohui Jia, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Jun Zhang, Master |
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Address:
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Telephone:
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86-311-85917384 |
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Email:
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june_luck@126.com |
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Affiliation:
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Name:
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Bojian Sun, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Dan Zhao, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Fan Zhang, Bachelor |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Name:
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Yang Shen, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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The First Hospital of Hebei Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of SLE(Systemic lupus erythematosus) from American College of
Rheumatology(ACR) according to established criteria in 1997
2. Age from 14 to 60 years
3. No serious infection or acute hemorrhage
4. Left ventricular ejection fraction (LVEF)= 50%
5. Both transaminase and serum creatinine level are more than twice times the upper limit
of normal
6. No acute infectious diseases.
7. Understanding and willingness to sign a written informed consent document.
Exclusion Criteria:
Patients with SLE have to be disqualified from this study if any of the following is
applicable:
1. SLE(Systemic lupus erythematosus) with severe infection.
2. Severe heart attack, liver and kidney disease following serious complications
3. Patients with allergic constitution.
4. Pregnancy and breastfeeding women.
5. Accompanied by malignant tumors or other malignant disease
6. Patients as participant in the other clinical text
7. Patients with active tuberculosis, acute sever hepatitis or infectious period of
diseases.
Age minimum:
14 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Biological: mesenchymal stem cells
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Primary Outcome(s)
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The change of Complement levels(C3 and C4) in peripheral blood
[Time Frame: Post cell transplantation: 1, 3, 6 months]
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Secondary Outcome(s)
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Erythrocyte sedimentation rate
[Time Frame: Post cell transplantation: 1, 3, 6 months]
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adverse reaction
[Time Frame: Post cell transplantation: 1, 3, 6 months]
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C-reactive protein
[Time Frame: Post cell transplantation: 1, 3, 6 months]
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Secondary ID(s)
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17277787D-SLE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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