Aplastic Anemia Clinical Trial
Official title:
Multi-center Clinical Study of Immunosuppressants, Cyclophosphamide, And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia
To assess whether ATG Combined With Cyclophosphamide and cord blood infusion can accelerate hematopoietic reconstruction in severe aplastic anemia patients and improve clinical curative effect and safety
Aplastic Anemia( AA), is a set of bone marrow hematopoietic dysfunction caused by a variety
of causes, with hyperplasia of bone marrow hematopoietic cells to reduce whole blood cells
and peripheral blood at the characteristics of clinical main performance for anemia,
bleeding and infection. According to the severity of the bone marrow failure and the
progress of the clinical course ,it is divided into Severe Aplastic Anemia (SAA) and the Non
- Severe Aplastic Anemia (NSAA).Severe Aplastic Anemia can be divided into two categories:
Very Severe Aplastic Anemia (VSAA) and Severe Aplastic Anemia (SAA), with the
characteristics of rapid progress, refractory, poor prognosis, high mortality .The natural
course is six months or so, and most patients die in a year . Hematopoietic stem cell
transplantation and immunosuppressive therapy are two main treatment . The former is by far
the only possible cure. It is recommended as first-line treatments, if patients have a
matched sibling donor. The recommended age limit is 40 years old. But for those who have no
sibling donor or patients older than 40 years old, it is recommend the immunosuppressive
therapy.
The investigators have already summarized the effectiveness of rabbit antithymocyte
immunoglobulin (ATG), cyclophosphamide (Cy) and cyclosporine, A (CsA) and the combination of
the umbilical cord blood infusion for SAA/VSAA patients without suitable donor, with short
duration, without long-term immunosuppressive therapy history. The total effectiveness rates
has improved to 88%, with shorter immunosuppressive maintaining therapy , rapid
hematopoietic reconstruction, fewer complications. The aim of this study is to further
explore whether this solution can accelerate hematopoietic reconstruction of SAA/VSAA
patients and its clinical curative effect and security. This study scheme has been approved
by the Jinan military region general hospital medical ethics committee.
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|---|---|---|---|
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