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Clinical Study of UC-MSC Combined With Immunosuppressive Agents in the Treatment of Pediatric HAAA

StatusCompleted
PhaseNot applicable
Started2021-09-01
View on ClinicalTrials.gov ↗
The goal of this clinical trial is to evaluate the effectiveness of umbilical cord mesenchymal stem cells combined with standard immunosuppressive therapy in children with HAAA, and to provide a new therapeutic idea for children with HAAA. Whether UC-MSC combined with immunosuppressants can improve outcomes in children with HAAA. Whether UC-MSC is safe in the treatment of children with HAAA. Participants will: 1 Age \< 18 years old, gender is not limited; 2 Diagnosis of hepatitis related aplastic anemia according to the criteria for hepatitis related aplastic anemia; 1. The patient has a history of acute prehepatitis, and the course of hepatitis is generally less than 6 months. The main clinical manifestations are fever, jaundice, anemia, bleeding, generally no liver enlargement. 2. Routine blood test: pancytopenia, HGB \< 100 g/L; Absolute neutrophil count \< 1.5×109/L; PLT \< 100×109/L (PLT reduction must be included in case of two-series reduction). Serum aminotransferase levels were elevated at least 200 U/L and hepatitis autoantibodies were negative. 3. Bone marrow aspiration and biopsy confirmed aplastic anemia. 4. Jaundice caused by other reasons and other pancytopenia diseases (such as congenital AA, clonal diseases and autoimmune diseases, etc.) are excluded. 3 No hematopoietic stem cell transplantation (HSCT); 4 The guardian and the subject will participate voluntarily and sign the informed consent;
Trial Details
NCT Number NCT07850362
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Hepatitis-associated Aplastic Anemia, Severe Aplastic Anemia(SAA), Umbilical Cord Blood, Mesenchymal Stem Cells, Pediatric
Enrollment 20 participants
Start Date 2021-09-01
Primary Completion 2025-08-30 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-30