Myelodysplastic Syndromes Clinical Trial
Official title:
Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat RA and RARS of MDS
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg on the subjects for refractory anemia (RA) and refractory anemia with ring sideroblast (RARS) of myelodysplastic syndromes (MDS).
Myelodysplastic syndromes are bone marrow stem cell disorders resulting in disorderly and
ineffective hematopoiesis. MDS is characterized by variable degrees of cytopenias (anemia,
neutropenia, and thrombocytopenia ) and risk of transformation to leukemia.
To date treatment of MDS is unsatisfactory: chemotherapy has a limited role in the
management of leukemic progression; autologous stem cell transplantation does not prolong
relapse-free survival and stem cell transplantation is poorly tolerated in older
individuals. Some MDS patients have been shown to respond to a wide variety of
immunosuppressive agents ranging from corticosteroids to CsA and antithymocyte globulin
(ATG). However, the overall response rate is less than 30%. In fact, few treatments appear
to change the natural history of MDS.
The management of MDS patients therefore remains to be improved. Human MSCs isolated from
Wharton's jelly of the umbilical cord/placenta have been shown to have immunosuppressive,
stimulating hematopoiesis and tissue repairing properties. This study will evaluate the
safety and effectiveness of MSC transplant in the MDS patients.
This study will last about 3 years. Participants will be randomly assigned to receive either
MSC transplant (Group 1) or CsA therapy alone (Group 2). Patients will undergo MSC
transplant at the start of the study (defined as Day 0). After 3 months, patients will
receive the second MSC transplantation when one responds well to the treatment. After 3, 6
and 12 months from the first transplantation, patients will be evaluated.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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