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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: |
NCT02247973 |
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Date of registration:
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17/09/2014 |
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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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Mesenchymal Stem Cells Co-transplantation in Alternative Donor Transplantation of Severe Aplastic Anemia.
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Scientific title:
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Phase?Trial of Co-transplantation With Bone Marrow Derived Mesenchymal Stem Cells From Related Donors in Alternative Donor Transplantation of Severe Aplastic Anemia. |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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100 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT02247973 |
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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 2
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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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Yang Xiao, 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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Guangzhou General Hospital of Guangzhou Military Command |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. In line with the 2009 Edition (United Kingdom) aplastic anemia diagnostic criteria
for SAA or VSAA;
2. Age less than 50 years old,willing to transplant;
3. No HLA-identical sibling donor;
4. Have HLA-mismatched related donors or unrelated donors ( =5/10 HLA matched loci in
related donors; =8/10 HLA matched loci in unrelated donors )
5. No serious infection or acute hemorrhage;
6. Cardiac ultrasound examination showed left ventricular ejection fraction is greater
than 50%;
7. Both transaminase and serum creatinine level are no more than twice times the upper
limit of normal value (ULN);
8. No acute infectious disease;
9. Ability to understand and the willingness to sign a written informed consent
document.
10. ECOG score of 0-2 points.
Exclusion Criteria:
1. Patients with severe infection or active bleeding;
2. With severe cardiac insufficiency, left ventricular ejection fraction <50%;
3. With severe liver dysfunction, liver function (ALT and the TBIL) is higher than the
ULN 3 times;
4. With severe renal insufficiency, renal function (Cr) is twice higher than the ULN; or
24-hour urine creatinine clearance rate (Ccr) lower than 50ml/min;
5. Active tuberculosis, severe acute hepatitis and other infectious diseases in active
period;
6. ECOG score more than 3 points;
7. Accompanied by malignant tumors and other clonal disease;
8. Poor compliance and the researchers considered unsuitable for MSC infusion.
Age minimum:
14 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe Aplastic Anemia
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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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survival rate
[Time Frame: up to 2 years after HSCT]
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Secondary Outcome(s)
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Rates of relapse
[Time Frame: UP to 2 years after HSCT]
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The implantation
[Time Frame: Up to 4 weeks after HSCT]
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Transplant-related mortality
[Time Frame: UP to 1 months after HSCT]
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acute GVHD
[Time Frame: UP to 3 months after HSCT]
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chronic GVHD
[Time Frame: UP to 2 years after HSCT]
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Secondary ID(s)
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MSC-alternative donor SCT-SAA
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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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