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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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19 February 2015 |
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Main ID: |
NCT02218437 |
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Date of registration:
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06/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment Protocol of Child SAA With the Injection of Mesenchymal Stem Cells(Umbilical Cord Derived)
MSC-SAA |
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Scientific title:
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Child With Severe Aplastic Anemia (SAA) Therapy: the Injection of Umbilical Cord Derived Mesenchymal Stem Cells. |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02218437 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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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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Xiaofan Zhu, MD |
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Address:
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Telephone:
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+86-22-23909001 |
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Email:
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zhuxf6465@gmail.com |
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Affiliation:
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Name:
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Xiaofan Zhu, MD |
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Address:
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Telephone:
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+86-22-23909001 |
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Email:
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zhuxf6465@gmail.com |
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Affiliation:
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Name:
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Xiaofan Zhu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chinese Academy of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Non-Severe Aplastic Anemia (NSAA)atients
Exclusion Criteria:
- Severe Aplastic Anemia (SAA) patients
Age minimum:
1 Month
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Complications of Organ Transplant Stem Cells Umbilical Cord
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Intervention(s)
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Drug: MSC+ATG
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Primary Outcome(s)
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The response and complete remission rate with different doses of Umbilical Cord Derived MSC to treat child with SAA
[Time Frame: 1 year]
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Secondary Outcome(s)
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The relapse rate with different doses of MSC to treat child with SAA
[Time Frame: 3-10 year]
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Secondary ID(s)
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H0806-MSC-2014
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MSC-2014-SAA-1
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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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