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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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19 February 2018 |
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Main ID: |
ChiCTR1800014907 |
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Date of registration:
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2018-02-17 |
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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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The clinical trial of using umbilical cord mesenchymal stem cell in children with idiopathic pulmonary hemosiderosis
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Scientific title:
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The clinical trial of using umbilical cord mesenchymal stem cell in children with idiopathic pulmonary hemosiderosis |
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Date of first enrolment:
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2018-03-01 |
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Target sample size:
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Experimental group:16;Control group:16; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=25429 |
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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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Other
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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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Ya-Ting Li
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Address:
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Pediatric Intensive Care Unit, Department of Pediatrics, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, Guangdong, China
510630
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Telephone:
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+86 13533449139 |
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Email:
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amy_lyt109@163.com |
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Affiliation:
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The Third Affiliated Hospital of Sun Yat-Sen University |
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Name:
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Ya-Ting Li
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Address:
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Pediatric Intensive Care Unit, Department of Pediatrics, The Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, Guangdong, China
510630
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Telephone:
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+86 13533449139 |
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Email:
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amy_lyt109@163.com |
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Affiliation:
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The Third Affiliated Hospital of Sun Yat-Sen University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. aged from 5-18 years old;
2. conforms to the IPH diagnostic criteria;
3. parents or guardians agree to treat and sign written informed consent.
Exclusion criteria: 1. combined with severe underlying diseases, such as systemic systemic malignancies, heart failure, liver and renal failure, immunodeficiency, severe infectious diseases, and other indications for emergency operation after lung transplantation;
2. patients with other pulmonary diseases;
3. who had previously participated in the clinical trials of stem cell therapy;
4. researchers think it is not appropriate to take part in other situations in the study.
Age minimum:
5
Age maximum:
18
Gender:
Both
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Health Condition(s) or Problem(s) studied
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idiopathic pulmonary hemosiderosis
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Intervention(s)
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Experimental group:Transplantation of hUC-MSCs;Control group:None;
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Primary Outcome(s)
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Episodes of annual pulmonary hemorrhage;
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Secondary Outcome(s)
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Incidence of adverse reactions;serum iron metabolism;T lymphocyte subset;Pulmonary function tests;sputum induction test;plasma inflammatory factors test;Number of circulating fibroblasts;
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Source(s) of Monetary Support
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The Third Affiliated Hospital of Sun Yat-Sen University, Clinical Research Program
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Ethics review
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Status: Approved
Approval date: 07/12/2017
Contact:
Chang Liu
+86 020-85252276
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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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