Clinical Research Directory

Inclusion Criteria: * Age 6-18 years, regardless of sex. * Availability of a related stem cell donor who was also the donor for the participant's original HSCT. * Poor graft function following allogeneic HSCT, defined as ANC \<0.5 × 10\^9/L for \>28 days with reduced bone marrow cellularity, after exclusion of acute GVHD, recurrence of the underlying disease, drug toxicity, and severe infection. * Insufficient autologous hematopoietic stem cell reserve and failure of conventional hematopoietic supportive treatment according to the protocol, including persistent neutropenia despite appropriate G-CSF; persistent severe thrombocytopenia or transfusion dependence despite thrombopoietin-receptor agonist treatment where indicated; unsuitability for or refusal of donor lymphocyte infusion, or an unfavorable benefit-risk assessment; and an investigator assessment that other supportive approaches do not provide sustained hematopoietic recovery. * No active infection, including normal body temperature for at least 72 hours and no evidence of infection on relevant cultures or imaging assessments. * No acute or chronic GVHD, or GVHD no greater than Grade 1, as specified in the protocol (see harmonisation note). * Written informed consent provided by the participant and/or legal guardian in accordance with applicable requirements. Exclusion Criteria: * Inherited bone marrow failure syndrome (e.g., Fanconi anemia) or hematologic malignancy. * History of non-hematologic malignancy. * Severe cardiac, hepatic, or renal dysfunction, including LVEF \<50%, creatinine clearance \<30 mL/min, or ALT/AST ≥3 × the upper limit of normal. * Active bleeding or coagulation disorder, including INR \>2 or APTT \>2 × the upper limit of normal. * Central nervous system involvement, including CNS infection or CNS involvement by malignancy. * History of hypersensitivity to culture components, including HEB-001 or the cytokines used for ex vivo expansion.