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This study evaluated the feasibility, safety, and immunological effects of intravenous administration of haploidentical mesenchymal stem cells (MSCs) in patients with relapse/refractory aplastic anemia (AA).Eighteen patients, including fourteen non-severe aplastic anemia (NSAA) patients and four severe aplastic anemia (SAA) were enrolled.Haploidentical MSCs were injected intravenously with a mean of 3.5 × 107(3-4.1 × 107).Four patients had injection-related adverse effects consisting of transient fever and two reported headache.No major adverse effects were reported during follow-up.Immunological analysis revealed an increase in the proportion of CD4+CD25+ FOXP3+ regulatory T cells.Following up one year, two of eighteen patients experienced a complete response with MSCs therapy at day 88 and 92, three patients achieved red cell recovery with hemoglobin >100g/L at day 30,35 and 48, two patients got platelet recovery with platelet count >60 × 10(9)/L at days 54 and 81.The current study supports the use of this approach for refractory AA.The trial has been registered at ClinicalTrials.gov: identifier NCT01305694.