ODALİS MARÍA DE LA GUARDİA PEÑA, ALEXİS LABRADA ROSADO, VİANED MARSÁN SUÁREZ, KATİA RODRÍGUEZ GUTİÉRREZ, LAURA RUİZ VİLLEGAS, MARY CARMEN REYES ZAMORA, CONSUELO MACÍAS ABRAHAM
Turkish Journal of Immunology - 2025;13(2):109-119
Objective: Thymic hypoplasia (TH) in children is a known cause of recurrent infections, often indicative of immunodeficiency. This study aimed to evaluate the efficacy of Biomodulina T, a thymic polypeptide fraction, in pediatric patients with TH, with or without associated cellular immunodeficiency. Materials and Methods: A non-controlled, phase III clinical trial was conducted among children aged 1–5 years (n=60) and registered in the Cuban Public Registry of Clinical Trials/ International Clinical Trials Registry Platform (ID code RPCEC00000247). Patients were divided into two groups: Group I (n=44), with TH without cellular immunodeficiency; and Group II (n=16), with TH and cellular immunodeficiency. Biomodulina T was administered intramuscularly (IM) in two 4-week cycles, separated by a 4-week rest period. Patients who had not achieved normal thymic size by week 16 received a third, 8-week cycle. Results: Both groups showed significant increases in thymic size from baseline (p<0.0001), with no significant difference between them. The mean increase was 67% (95% CI 61–73%), and 86.5% of patients completed treatment with thymic size within the normal range. Bacterial infections decreased by 91.5%, and viral infections by 80.7%, accompanied by a reduction in antibiotic use. In patients with cellular immunodeficiency, Biomodulina T significantly increased in CD4+ T lymphocytes (p=0.018), while no significant changes were observed in CD8+ T cells, CD19+ B cells, and CD56+ natural killer (NK) cells. Serum immunoglobulin A (IgA) levels also increased significantly. Overall, 82.7% of patients were classified as improved, showing both normalization of the thymic size and a 50% reduction in infections. Conclusion: Biomodulina T was clinically effective in the treatment of TH in children, regardless of the presence of cellular immunodeficiency.
