Medicine today focuses largely on diagnosing existent medical conditions and remediating them, typically with surgery, drugs, chemicals, radiation, or some combination thereof.
Why wait for a problem to happen that you know will happen? Most people don't die of old age or one disease or condition: most people die of multiple diseases or chronic conditions stemming from or exacerbated by the confluence of common root causes: decline of immune system function, oxidative stress, and chronic inflammation.
We know diet and exercise can help mitigate these conditions. But even people with good diets and exercise die of diseases medicine cannot cure because they lack immune system functionality to combat the disease, and medicine or drugs often impair the body's ability to fight for itself. Jack Lalanne died of pneumonia at age 95, in nearly perfect health until a fatal moment. He wanted to live to 120, and believed he could through good exercise and diet. Diet and exercise matter but have limitations. Medicine helps but makes trade offs that further weaken the body's own immune functions.
What if we could better predict predisposition for disease? What if we could address systemic issues that form the root cause of many symptoms we call diseases? Heart disease, cancer, Parkinson's, dementia, Alzheimer's, Rheumatoid arthritis, sclerosis -- all inextricably linked to inflammation and aging of other tissues effected by declining immune function -- could be better predicted and better prevented from developing in the first place.
We hope in our study to develop indicators to predict potential for disease states before they occur, and treatment therapies to prevent those diseases from occurring at all. Many of the blood tests we perform have predictive potential, and we hope to extend our test suite as we accumulate data and discover patterns of commonality with rich, big data sets.
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.