[Translation] A dose-escalation phase I clinical study evaluating the safety, tolerability, and preliminary efficacy of umbilical cord blood megakaryocyte injection (XJ-MK-002 injection) in patients with thrombocytopenia caused by aplastic anemia (AA).
主要目的:评价XJ-MK-002注射液治疗再生障碍性贫血(AA)所致血小板减少症的安全性和耐受性,为后续研究推荐合适剂量。
次要目的:评价XJ-MK-002注射液治疗再生障碍性贫血(AA)所致血小板减少症的初步有效性。
[Translation] Primary objective: To evaluate the safety and tolerability of XJ-MK-002 injection in the treatment of thrombocytopenia caused by aplastic anemia (AA), and to recommend appropriate dosage for subsequent studies.
Secondary objective: To evaluate the preliminary efficacy of XJ-MK-002 injection in the treatment of thrombocytopenia caused by aplastic anemia (AA).