Amnion-Derived Multipotent Cell Secretome-Mediated Therapy for Gulf War Illness
Abstract
Many soldiers returning from the Gulf War (GW) reported various health symptoms following their deployment, a phenomenon known as Gulf War Illness (GWI). Symptoms reported by GW Veterans vary widely but include widespread pain, muscle aches, skin abnormalities, chronic fatigue, fibromyalgia, gastrointestinal disorders, and problems with memory and thinking. Exposure to toxic levels of pesticides, as well as anti-nerve gas agents, has been identified as causing GWI, and mouse models have been created in order to better understand the illness and identify treatments. An ideal treatment would not only improve the symptoms of GWI but also treat the underlying cause of the disease. The main complication in treating GWI, however, is the fact that its clinical presentation is very diverse, and it appears to be multisystemic and involve several possible disease processes. Chronic neuroinflammation has been reported in patients and in animal models of GWI, therefore we propose to test a novel treatment, ST266, which acts on multiple targets including neuroinflammation. The objective of this application is to evaluate a novel cell-free therapeutic delivered intranasally in two different mouse models of GWI that include modeling the comorbidity of physiological stress. The therapeutic, ST266, is the first of its kind cell-free therapeutic with the potential to improve patients outcomes across a range of challenging diseases and conditions. The components of ST266 are secreted by amnion-derived epithelial cells (the secretome) collected from full-term placentas, normally discarded after birth, with a proprietary method developed by Noveome Biotherapeutics, Inc. The cells produce many of the biological factors found in amniotic fluid that may be responsible for the healing capabilities and lack of scarring observed following in utero fetal surgery. ST266 comprises molecules in the cell secretome that modulate inflammation, accelerate wound healing, improve intestinal immunity, and potentially reduce or eliminate these symptoms. This approach may be more relevant to address the complex problems of GWI than a drug that targets a single molecule. We will use two different mouse models of GWI, one which includes a physiological stressor known to exacerbate symptoms in GWI patients. We will begin treatment at 12 months after exposure to the GW agents, in order to better mimic the current GWI patient population who received their toxic exposures more than 30 years ago. The three aims of the project s investigations are to: (1) determine whether long-term administration of the cell-free therapeutic ST266 ameliorates the neurobehavioral outcomes in aged mice after GW neurotoxicant exposures; (2) evaluate the effect of chronic treatment with ST266 on neuropathological and biochemical markers of neuroinflammation after GW neurotoxicant exposures in aged mice; and (3) identify and validate objective biomarkers for the diagnosis of GWI and for assessing treatment efficacy. At the conclusion of this 3-year project, our findings could significantly impact the health of Veterans with GW symptoms, and their families, by offering them new therapeutic approaches to treat not only their symptoms but also potentially the underlying cause of the illness. Considering that ST266 has been approved by the U.S. Food and Drug Administration and is currently in use in human clinical trials with no reported adverse events, we anticipate that positive results from this preclinical study could rapidly translate into clinical testing for GWI patients, for whom currently there is no effective treatment.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310749
Entities
People
- Benoit Mouzon
Organizations
- Roskamp Institute
- United States Army