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Developed by the University of Florida, this investigational combination therapy is designed to preserve pancreatic beta cell function in children with recently diagnosed type 1 diabetes mellitus. The treatment protocol involves a single intravenous infusion of the patient's own (autologous) cryopreserved umbilical cord blood, which is rich in regulatory T cells (Tregs) and other stem cell populations, followed by a one-year regimen of daily oral vitamin D and omega-3 fatty acid supplementation. The therapeutic rationale is based on the ability of Tregs to suppress the autoimmune destruction of insulin-producing beta cells, while vitamin D and omega-3 fatty acids provide additional anti-inflammatory and immunomodulatory support. Although clinical trials, such as NCT00873925, demonstrated the safety of the approach and observed changes in Treg frequency, the therapy ultimately failed to significantly preserve endogenous insulin production as measured by C-peptide levels.
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