Comprehensive Review of the Safety and Efficacy of Thymosin Alpha 1 in Human Clinical Trials.

Objective: This study aims to assess the safety and efficacy of Thymosin Alpha 1 (Tα1) through a comprehensive narrative review of clinical studies involving over 11 000 human subjects in more than 30 trials. The focus was on Tα1's application in COVID-19, autoimmune conditions, and cancer treatment, with implications for future considerations. Methods: We systematically searched articles relevant to critical studies on COVID-19, infectious diseases, cancer, and autoimmune diseases indexed on Pubmed, Google Scholar, and Cochrane Library. Our focus was on evaluating the safety and efficacy of Tα1 in human subjects. Clinical trials conducted worldwide involving diverse populations were analyzed to assess the safety and effectiveness of Tα1. The review examines explicit outcomes in over 11 000 human subjects, emphasizing its role in addressing COVID-19, autoimmune conditions, and cancer treatment. Results: Contrary to the FDA's restriction on Tα1 and 21 additional peptides in 2023, our analysis reveals consistent evidence of Tα1's safety and efficacy. The peptide has demonstrated significant effectiveness in treating various conditions, including COVID-19, autoimmune disorders, and cancer. This review summarizes conclusions drawn from a comprehensive examination of clinical trials worldwide. Conclusions: Based on substantial evidence from clinical trials, Tα1 emerges as a well-tolerated and effective immune modulator. The FDA>s restriction appears unfounded, as Tα1 has shown safety and efficacy beyond the initially specified conditions. Urgent attention and intervention are warranted to ensure the continued availability of this life-saving peptide through prescription. Therefore, it is recommended that the FDA permits 503A compounding pharmacies to compound Tα1, considering its potential to treat a variety of conditions effectively.

Thymosin beta-4 - A potential tool in healing middle ear lesions in adult mammals.

Acute tympanic membrane perforations primarily occur due to injury or infection in humans. In acute cases, nearly 80-94 % of the perforations heal spontaneously. In chronic cases, non-surgical treatment becomes significantly limited, and the perforation can be restored only by myringoplasty. In addition to classical grafts such as the fascia or cartilage, promising results have been reported with various biological materials including silk or acellular collagen. However, despite of all the efforts, healing remains insufficient. Consequentially, a need for substances which actively promote tympanic cell migration and proliferation is deemed essential. In our study, we utilized Thymosin beta-4 (TB4), a 43aa peptide possessing many regenerative properties in various organ systems. Our aim was to reveal the impact of externally administered TB4 regarding impairments of the middle ear, particularly the tympanic membrane. We harvested tympanic membranes from adult mice and treated these with TB4 or PBS on both collagen gel matrixes and in the form of floating, ex vivo explants. Cell migration and proliferation was measured, while immunocytochemical analyses were performed to determine cell type and the nature of the targeted molecules. We discovered the peptide affects the behavior of epidermal and epithelial cells of the tympanic membrane in vitro. Moreover, as our initial results imply, it is not the differentiated, yet most likely the local epidermal progenitor cells which are the primary targets of the molecule. Our present results unveil a new, thus far undiscovered field regarding clinical utilization for TB4 in the future.

Effect of thymosin alpha-1 on subpopulations of Th1, Th2, Th17, and regulatory T cells (Tregs) in vitro

Thymosin alpha 1 (Tα1) has been shown to have beneficial effects on numerous immune system parameters, but little is known about the effects of Tα1 on patients with gastric carcinoma. The objective of this study was to determine the effect of Tα1 on subpopulations of Th1, Th2, Th17, and regulatory T cells (Tregs) in vitro, and to evaluate its efficacy as an immunoregulatory factor in patients with gastric carcinoma. We compared the effect of Tα1 on the frequency of CD4+ and CD8+ T cells, especially the CD4+CD25+Foxp3+ Tregs in peripheral blood mononuclear cells (PBMCs) from gastric carcinoma patients (N = 35) and healthy donors (N = 22). We also analyzed the changes in the proliferation of PBMCs in response to treatment with Tα1, and examined the production of Th1, Th2, and Th17 cytokines by PBMCs and tumor-infiltrating lymphocytes. The treatment of PBMCs from gastric cancer patients, with Tα1 (50 µg/mL) alone increased the percentage of CD4+CD25+Foxp3+ (suppressive antitumor-specific Tregs) from 1.68 ± 0.697 to 2.19 ± 0.795 percent (P < 0.05). Our results indicate that Tα1 increases the percentage of Tregs and IL-1β, TNF-α, and IL-6 in vitro.

Perspectivas de tratamiento para COVID-19 (en progreso) / Treatment prospects for COVID-19 (in progress)

CONTEXTO: Debido a la contingencia por COVID-19 provocada por el nuevo coronavirus, SARS-CoV-2, en la actualidad hay una intensa investigación de alternativas terapéuticas que sean seguras y eficaces. (Hay registrados 2208 protocolos de estudios en ClinicalTrials.gov1). Con el propósito de conocer el panorama terapéutico actual contra COVID-19, se realizó una búsqueda exhaustiva de las alternativas que han demostrado cierta eficacia en esta infección, concluyendo que los estudios que se han realizado tienen limitaciones metodológicas. Se trata de estudios no controlados, con alta probabilidad de sesgos que comprometen la validez interna y externa, consideran evidencia indirecta o la experiencia de expertos ante esa emergencia sanitaria, por lo que toda recomendación derivada de estos documentos debe de tomarse con extrema cautela. El uso de esas alternativas debe considerar los riesgos y los beneficios en casos individuales, en una decisión compartida entre médicos, pacientes y familiares ya que la mayoría de la evidencia se considera de baja o muy baja calidad. A la fecha no existe tratamiento específico en contra de este virus. BÚSQUEDA REALIZADA: Inmunoglobulinas intravenosas: Las inmunoglobulinas intravenosas (IgIV) es un grupo de IgG obtenido de donantes sanos, expuestos a enfermedades infecciosas endémicas, vacunas y microorganismos ubicuos que participan en la producción de anticuerpos IgG contra diferentes microorganismos y sus productos. El uso de inmunoglobulina intravenosa se ha

Poliartritis como manifestación de infección por virus C de la hepatitis: presentación de dos casos clínicos / Hepatitis virus C infection presenting as a polyarthritis: report of two cases

Several diseases have been associated with hepatitis C virus infections, including rheumatologic, hematologic and neoplastic disorders. We report two women, aged 57 and 39 years old whom the initial presentation of hepatitis C virus infection was an arthritis resembling rheumatoid arthritis. Laboratory work up revealed abnormal liver function tests, stimulating the search for hepatitis C virus infection, having both patients positive ELISA tests. Detection of this agent is extremely important when selecting a therapy for the articular disease, since several drugs used in the treatment of rheumatic disorders are potentially hepatotoxic and immunosuppression is risky in the setting of a viral hepatitis

Estudo clínico-imunológico da eficácia de timomodulina (Leucogen©) na otite média aguda recorrente e na amigdalite de repetição / Assessment of efficacy and safety of thymomodulin (Leucogen©) in the prevention of recurrent otitis media and recurrent tonsillitis

Os autores realizaram estudo em 35 crianças portadoras de otite média aguda recorrente e amigdalite de repetiçäo em um estudo duplo-cego com timomodulina e placebo. As crianças tratadas com timomodulina© receberam 4mg/kg/dia do medicamento diariamente durante três meses. Foi realizado controle bioquímico antes do tratamento e com cinco meses e nove meses após o término do tratamento. Além da avaliaçäo clínica foram realizados os seguintes exames: hemograma, TGO, TGP dosagem de IgA, IgG, IgM e IgE antes do início do tratamento e nos controles. Os resultados evidenciaram tendência à diminuiçäo do número de infecçöes e o número de ciclos de antibióticos, em relaçäo a informaçäo do último ano (pré-tratamento), principalmente no grupo tratado com timomodulina, assim como tendência ao aumento do IgA e IgG após tratamento com timomodulina, o que näo ocorreu no grupo placebo. Os exames laboratoriais, contagem de eritrócitos, de hematócrito, hemoglobina, leucócitos e transaminases (TGO e TGP) näo mostraram diferenças entre os grupos, nem alteraçöes 12 meses após o início da medicaçäo, evidenciando a ausência total de toxicidade da timomodulina. Houve apenas um efeito colateral com o uso de timomodulina (náusea e vômito) numa criança com amigdalite purulenta que tomou cefalexina concomitantemente

Caracterización fisicoquímica de una fracción de timo. I. Aspectos generales. / Physico-chemical characterizationof a thymic fraction. I. General considerations

Los factores del timo (o timosinas) desempeñan un papelpredominante entre los biomodulares. El uso de fracciones del timo en el tratamiento de las disfunciones del sistema inmune se ha generalizado durante la últimadécada. La obtención de fracciones de timo a escala de planta piloto o industrial, precisa de un sistema de pruebas que garanticen, por medio de un adecuado control, la calidad de su estabilidad terapéutica. Con este objetvo se presenta la primera parte del diseño de un sistema de control, para caracterizar una serie de variables no referidas a la cantidad y calidad de los componentes de la biomodulina T (BMT)