Treatment Protocol of Child SAA With the Injection of Mesenchymal Stem Cells（Umbilical Cord Derived）
NCT ID: NCT02218437
Last Updated: 2014-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2013-10-31
2015-10-31
Brief Summary
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Detailed Description
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2. The starting dose of Umbilical Cord Derived MSC was 0.5-1.0 \* 106 cells /kg, based on the previous human studies; And the maximum tolerated dose was 1 \* 107 cells /kg
3. The response and complete remission rate, relapse rate of the injection of Umbilical Cord Derived Mesenchymal Stem Cells (or combined with ATG ) for Child with SAA were determined.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MSC+ATG
The first agent MSC injection, began two weeks after ATG application; Each patient was injected three times, one time per week; Study on single dose tolerance and efficacy index; Each subjects received three dose groups of treatment.
MSC+ATG
MSC+ATG:Starting dose was 0.5-1.0 × 106 cells /kg; And the maximum tolerated dose was 1 ×107 cells /kg after ATG application.
Interventions
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MSC+ATG
MSC+ATG:Starting dose was 0.5-1.0 × 106 cells /kg; And the maximum tolerated dose was 1 ×107 cells /kg after ATG application.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Month
18 Years
ALL
Yes
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Xiaofan Zhu
chief physician
Principal Investigators
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Xiaofan Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
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Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Lan Y, Liu F, Chang L, Liu L, Zhang Y, Yi M, Cai Y, Feng J, Han Z, Han Z, Zhu X. Combination of umbilical cord mesenchymal stem cells and standard immunosuppressive regimen for pediatric patients with severe aplastic anemia. BMC Pediatr. 2021 Feb 27;21(1):102. doi: 10.1186/s12887-021-02562-x.
Other Identifiers
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H0806-MSC-2014
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MSC-2014-SAA-1
Identifier Type: -
Identifier Source: org_study_id
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