The Mexican population widely uses traditional medicine from herbal treatments, alternative
therapies, and the well-known “immuno-modulator,” which aims to relieve both allergic and
autoimmune diseases by modulating the immune response. Theoretically, it has been managed that
auto-allergens are eliminated in the urine, cytokines released according to the inflammatory
response of each individual. In the ’50s, Dr. Maximiliano Ruiz Castañeda develops a method to take
advantage of the eliminated elements in the urine to induce an immunomodulatory response.
The treatment has been employed for more than 50 years of uninterrupted use, partly supporting its
effectiveness. However, no previous study has determined the composition of this
immunomodulator. Despite the benefits of this treatment, the molecular mechanisms underlying its
effects have not been thoroughly investigated. Therefore, this study aims to identify
immunoregulatory peptides, such as cytokines and growth factors, in the immune-modulator, and
las physical, chemical, and quality characteristics to effectively and safely use this product. Urine and
immune-modulator concentrations of cytokines and growth factors were assessed using a Luminex
assay. Twenty-one cytokines and growth factors were identified in immune-modulator samples.
MCP-1 was identified in 100% of the samples; MIP-1β, IL-8, RANTES, INF-γ, and IP-10 were identified
in approximately 65–70% of samples; IL5, IL-1B, and IL-17 in 50–60%; eotaxin, VEGF, IL-6, and FGF in
about 40%; MIP-1α, IL-9, GM-CSF, G-CSF, IL-12, and IL-15 in about 20–30%; other were found in less
Additionally, patients exhibited significant changes in IL-1β, IFN-γ, and MCP-1 concentrations after
treatment with the immune-modulator. The immune-modulator is an alternative treatment based on
the sublingual administration of cytokines and growth factors obtained from the urine of patients. In
this study, its composition was characterized. pH, sterility was also verified. The isolated products
could be responsible for the effects of the immune-modulator. Further trials are required to evaluate
the effective delivery of these molecules by the administration route described