For us, a randomized clinical trial takes little to no incremental effort at all: no placebo effect can be attributed to blood plasma exchange, per se, so we simply gather random blood samples from people over 50 for 6 treatments, and subseqently, compare the results with subjects receiving Heterochronic Plasma Exchange 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. So, within our means, we will treat each and every one of our qualifying subjects with real HPE procedures, up to our initial study size of 1,000 patients, in the sincere hope of mitigating or improving any number of chronic conditions, or preventing the potential thereof.
For a risky new and unproven drug or drug-based immunotherapy with potential for cross reactivity, strict adherence to randomized clinical trial protocols with small population of volunteer subjects makes clear and regulatory sense.
Therapeutic Plasma Exchange, on the other hand, has decades ago been approved by the U.S. F.D.A. as well as numerous international regulatory bodies; TPE may be one of the lowest risk medical procedures available today. We intend to conduct clinical trials and to prove up beneficial effects we likely know to be the case, but has not been measured and documented for our study group demographic comprehensively. Yes, 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 simply hasn't been treated with TPE and measured comprehensively. We know that 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, or HPE 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. Given the pace of insurance companies and the medical establishment, that could take a few years, of course.