Journal of IiME Volume 7 Issue 1 4) Treatment: Phase 2: Other therapy mono and combination pilots Goal: To assess the effect of other touted treatments that are currently available in the field and establish immunologic and molecular parameters for measuring the efficacy of such treatments. Treatments assayed will include: Ampligen, Famvir, Etanercept, Rifaximin, Issentris, and possibly others. Importance:To determine a direction and baseline for other potential drug therapies in the field and assess which should receive additional allocation of funds for research. 5) Immunologic Biomarker Exploration Studies Goal:These exploratory studies will examine B-cell, Tcell and Natural Killer cell responses to disease and treatment groups using comprehensive, rigorous methods many of which have never before been applied to ME/CFS. It will seek to establish immunologic baselines and variants from that across the patient population. Importance:For a disease that appears to have a solid immunologic component to it, this study will provide the most advanced, longitudinal characterization of immune changes in critically implicated cells over selected treatment and control patients. 6) DNA Genetics-Funded Goal:Use the most advanced methods to sequence key areas of the human genome in a set of patients and controls and affected families and unrelated individuals. Utilizing advanced Human Genome Project technologies, this project will undertake HLA and other regional sequencing of areas of interest for selected patients and families. Importance:Establishing or refuting a role for genetics and potential heritable risk in ME/CFS. 7) Mass Spectroscopy/Environmental Measurements Goal:This exploratory study will search patient samples for unknown compounds, toxins, proteins and other substances that may be implicated in the genesis of the disease or otherwise contribute to immune dysfunction. Importance: This would be the first systematic examination of samples by the most reliable substance identification techniques to begin to establish an understanding of the contribution of nutritional and environmental factors to ME/CFS. 8) Comprehensive Viral Testing Goal:Establish a core of viral testing methodologies that are useful and could be useful clinically. Testing will include blood, urine, and saliva and other tissues where available for specific viruses such as EBV, HHV6, CMV, Parvovirus, HSV1, HSV2, and additional Invest in ME (Charity Nr. 1114035) (May 2013) panel type testing for novel viral identification and high throughput methods. Importance: This project will set the standard for clinical viral testing in ME/CFS and establish a guideline for evaluation and treatment directions for patients. Priority given to assays that have already yielded promising clinical results in partner labs. 9) Advanced Immunologic Biomarker Study 2 Goal: This secondary immune study will look at additional cell types that complement project #5 above, such as monocytes, macrophages and dendritic cells. Importance: This study extends our immunologic understanding of the disease and its extent. 10) Treatment: Phase 3: Natural and Over-theCounter substances-Moringa pilot funded Goal:Examine the potential benefit of several over the counter/natural therapies in a vetted scientific setting. Substances examined will include: Moringa oleifera, GcMAF, Vit B12, and Artemesinin. Importance:This project will be a first application of vetted scientific method and molecular science to non-pharmacologic substances that have had anecdotal benefits reported, thereby setting a standard for mainstream measurement of ME/CFS. Answers to inquiries: 1. The studies are listed in priority order, voted on by the OMI-MERIT group, however each study will start as soon as it’s funded. We have several donors that have specified which project they will fund. We will announce them as we are funded. 2. We have been fully funded for the OMI-MERIT, Project #6, DNA Genetics study and we have been partially funded for Project #10, a Moringa oleifera study, and partially funded for Project #2 the Registry and Biobank. 3. We will make announcements via Press Release, the OMF e-newsletter, the OMI Website & Facebook 4.The Open Medicine Institute (OMI) is a Community Benefits Corporation committed to applying a multidisciplinary, big data approach to the health care system to advance the understanding of “difficult” diseases and improve patient outcomes. 5.The Open Medicine Foundation (OMF) is a U.S. 501(c)(3) nonprofit with an aggressive mission: Invest in accelerating collaborative medical research to find effective treatments and diagnostic markers, current focus, ME/CFS. Keep the community informed by disseminating information on current research projects and results. Bring together thought leaders from around the world to brainstorm and participate in targeted initiatives. Encourage and engage the patient community to take an active role in their own health care. www.investinme.org Page 33 of 36
34 Publizr Home