Status:
UNKNOWN
Mesenchymal Stem Cells Co-transplantation in Alternative Donor Transplantation of Severe Aplastic Anemia.
Lead Sponsor:
Guangzhou General Hospital of Guangzhou Military Command
Collaborating Sponsors:
Guangzhou First People's Hospital
Nanfang Hospital, Southern Medical University
Conditions:
Severe Aplastic Anemia
Eligibility:
All Genders
14-50 years
Phase:
PHASE2
Brief Summary
The study is a phase II trial designed to evaluate the efficacy and safety of co-transplantation with bone marrow derived mesenchymal stem cells from related donors in alternative donor transplantatio...
Detailed Description
Aplastic anemia (AA) is an autoimmune hematologic stem cell disease mediated by activated T-lymphocytes that leads to bone marrow dysfunction. In the presence of an empty marrow, pancytopenia, and tra...
Eligibility Criteria
Inclusion
- In line with the 2009 Edition (United Kingdom) aplastic anemia diagnostic criteria for SAA or VSAA;
- Age less than 50 years old,willing to transplant；
- No HLA-identical sibling donor；
- Have HLA-mismatched related donors or unrelated donors ( ≥5/10 HLA matched loci in related donors; ≥8/10 HLA matched loci in unrelated donors )
- No serious infection or acute hemorrhage;
- Cardiac ultrasound examination showed left ventricular ejection fraction is greater than 50%;
- Both transaminase and serum creatinine level are no more than twice times the upper limit of normal value (ULN);
- No acute infectious disease;
- Ability to understand and the willingness to sign a written informed consent document.
- ECOG score of 0-2 points.
Exclusion
- Patients with severe infection or active bleeding;
- With severe cardiac insufficiency, left ventricular ejection fraction \<50%;
- With severe liver dysfunction, liver function (ALT and the TBIL) is higher than the ULN 3 times;
- 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;
- Active tuberculosis, severe acute hepatitis and other infectious diseases in active period;
- ECOG score more than 3 points;
- Accompanied by malignant tumors and other clonal disease;
- Poor compliance and the researchers considered unsuitable for MSC infusion.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02247973
Start Date
February 1 2013
End Date
February 1 2018
Last Update
September 25 2014
Active Locations (1)
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1
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, China, 510010