Currently $500,000 has been raised to fund an international university approved Institutional Review Board three-part program. Fundraising is ongoing for the FoundTheCure Foundation. Patient selection will be Crohn's patients: untreated, treatment failures and surgical failures.
Part I: Biomarkers for Crohn's Disease. The ELISA measurement of the nuclear membrane estrogen receptor-beta/ alpha ratio will confirm the European physicians' findings that the ratio precipitously decreases from normal in flairs of Crohn's Disease. Scientifically, this will add to the worldwide support to confirm the intracellular estrogen receptor beta/ alpha ratio as the sine-que-none biomarker for Crohn's disease.
Bio-available testosterone, measured as Free Androgen Index (FAI) should be highly correlative and serve as a readily and inexpensive serum hormonal biomarker. The components of the FAI, total testosterone and sex-hormone-binding globulin may also be independently and highly correlated.
Part II: Tissue Cultures: In Vitro. The T-lymphocyte cell line is grown in culture. The baseline estrogen receptors alpha and beta and eight humoral cytokines are measured by spectrophotometry means. The tissue culture will have aliquots of pharmaceutical commercial biologic drugs in one arm and pharmaceutical anabolic steroids in the second arm. The responses of the estrogen receptors beta/ alpha and 8 cytokines will be cross compare across the study arms.
Part III: In Vivo Study: Background Information: There are more than 100 published cases in the peer-reviewed medical literature of the use of oral oxandrolone in European adult men with Crohn's Disease. There is a study by Nasser of up to 7 year follow up of testosterone replacement in men with Crohn's disease in Syria and Germany. To this literature, Lichten added five-year follow up of two men with Short Bowel Syndrome after Crohn's surgery. His third patient, Ben, with ulcerative colitis was able to clear the disease when treated aggressively at the earliest possible convenience.
The patients from Part II having failed medication and/ or surgery will be offered the mixed anabolic steroid therapy as weekly injections. The venous T-lymphocytes and FAI will be redrawn at 1, 3 and 6-months. The observed correlation between signs, symptoms, and the biomarkers and cytokines will be scrutinized and reported at the Fall Crohn's and Colitis Foundation Biomarker Symposium.
Since the estrogen receptor beta is a testosterone receptor, adding back the mixture of anabolic steroids should offer superior improvement to the estrogen receptor beta/alpha ratio versus the biologic medications. This may correlate with reduction of signs and symptoms, and reduced need for biologic medications and surgery in this population.
A board-certified Canadian university affiliated physician has selected the initial volunteers for the study. The study seeks additional medication and surgical failure patients including those with Short Bowel Syndrome.
The in vivo study for those whom do not have the estrogen receptor and cytokine components will include the baseline FAI testing and weekly injections for two months, then repeat laboratory testing and medical review. There are zero initial medication costs for volunteers who will supply confirmatory letters of endoscopic proven biopsy, diagnosis, previous medications, successes and present failures of medical and surgical treatments.
Treatments will be available at a minimal cost. No cost three-way consultations will be available to the treating physician and patient. Consent forms will be signed by the supervising physician investigator.
The impact is even greater in the Canadian population than the American population.
There is a 3-4x greater incidence of Crohn's and ulcerative colitis in Canada versus the United States. The introduction of GMOs in 1996, correlate with a tenfold increase in IBD in the youngest children in Canada. There has been more than a 50 percent overall increase in the prevalence of Crohn's and colitis in Canadian children in the past 10 years. By 2030, the number of Canadians with IBD is expected to rise to 400,000, approximately 1 percent of the population and equal in incidence to Type I diabetes. As the Canadian health system does not routinely pay for Humira®, Remicade®, Entyvio®, Stellara® or other TNF-agonist medications (anti-inflammatories), many patients go directly from high dose corticosteroids/ Prednisone® and methotrexate to surgery. Canada has 75 government run treatment centers for the treatment of IBD.
More than 320/100,000 individuals in the United States and 690/100,000 individuals in Canada are impacted by IBD. The incidence is expected to rise 25 percent worldwide for the next 10 years. IBD is now appearing for the first time in the suburbs of major Chinese cities. The annual cost of medications to treat IBD in the US are between $70,000-220,000; surgeries can run from $50,000-150,000. The estimated direct costs are $30 billion dollars lost annually from the United States economy and $3 billion for Canada.
