Chinese patients will soon have the opportunity to take part in a study of a novel therapy aimed at reversing the autoimmune disease, ankylosing spondylitis. Approximately 200 patients will be chosen to participate in a clinical trial that aims to merge the latest molecular discoveries published by the California non-profit Autoimmunity Research Foundation (ARF) with the medical expertise of physicians and researchers at West China Hospital.
Located at Sichuan University, West China Hospital is the largest clinical center in the world, with 4600 beds and 2.5 million outpatients per year. It is also is the Chinese center for the worldwide Cochrane Collaboration in evidence-based medicine.
The treatment protocol is based on a molecular understanding of the interaction of intracellular and biofilm bacteria with the operation and control of the body's nuclear receptors. Dysregulation of these receptors has been shown to promote the systemic inflammation, immunosuppression, and hormonal imbalances characteristic of chronic disease.
The NIH Human Microbiome Project now estimates that approximately 90% of cells in the human body are bacterial or otherwise non-human in origin. Yet it has only been over the past decade that advanced DNA bacterial identification tools have begun to reveal the true impact of these microbes, many of which have yet to be characterized and identified. Estimated to number in the billions, the accumulation of different species of pathogenic bacteria has been implicated in dozens of chronic disease states. ARF has discovered how to restore nuclear receptor homeostasis so that the body's own immune system can fight these pathogenic bacteria.
The East-West partnership, which will eventually include subjects suffering from other chronic diseases, will serve as a better-controlled and more formalized version of a trial that the Autoimmunity Research Foundation has been conducting over the past several years. These trials are aimed at moving the molecular discovery known as the Marshall Protocol as quickly as possible from bench to bedside.
Data from the initial ARF trial has been presented at conferences around the world from Karolinska, Sweden to Beijing, China. Detailed data showing that a majority of participants experienced symptomatic resolution or disease reversal from 20 autoimmune diagnoses, ranging from lupus to arthritis to thyroiditis was presented by Captain Tom Perez at the 2008 International Congress on Autoimmunity in Portugal.
"As a physician who has seen hundreds of patients respond positively to the therapy that will be tested at WCH I think data collected from the upcoming trial may very well be groundbreaking," states Dr. Greg Blaney of Vancouver, Canada.
The collaboration is scheduled to begin at the end of August when researchers from ARF will travel to China to work with the WCH staff getting the study underway.
Both groups will also join together in applying for research grants from both public sources and private donors to ensure that the maximum possible number of participants with a wide range of diseases is eventually able to participate.
Source: Autoimmunity Research Foundation
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