For many interventional studies, a randomized clinical trial takes little to no incremental effort at all: in the case of TPE, we simply gather random blood samples from people over 50 for 6 treatments, and subsequently, compare the results with subjects receiving the intervention therapy.
Nearly 8 years worth of data and study from the AMBAR pilot and follow-on studies demonstrate beneficial effects of TPE on a majority of subjects, for example. However, undocumented insights from medical practitioners in that study suggest other potentially beneficial effects that might provide interesting biomarkers in the future. Therapeutic Plasma Exchange has decades ago been approved by the U.S. F.D.A. as well as numerous international regulatory bodies; and TPE may be one of the lowest risk medical procedures available today. We conduct clinical trials that intend to prove up (or not) beneficial effects we likely suspect to be the case, but that have not been measured and documented for our study group demographic comprehensively. We do have data on improvements in Alzheimer's, and we have select data on accepted autoimmune conditions in older patients. But more comprehensive measurement of systemic root causes of age-associated disorders hasn't been treated with TPE and measured comprehensively. We believe that many if not most age associated disorders have common root cause in immune system decline, oxidative stress, and chronic inflammation -- all conditions which can be addressed and improved by TPE in the application to systemic decline of aging immune systems. With supporting data, this treatment therapy might become broadly available as a medically insured prophylactic (preventive) treatment therapy for age-associated disorders.
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June 2024
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