About our project
Life without Kidneys is nearly impossible, it would be like living without sanitation or garbage removal from your home. Toxins accumulate in the blood and an inevitable decline begins when disease and chronic conditions attack the kidneys. Over 80,000 Americans and over 200,000 people worldwide live in a state of Kidney Failure, living on dialysis and waiting for a kidney transplant. About 25% of these people will die waiting for that kidney every year.
Our product, Biocysan® can help prevent Kidney Disease according to preliminary studies and published research. We have come to MedStartr to fund a larger scale clinical trial to prove once and for all that our product can help prevent kidney disease and treat people in kidney failure. The “Gold Standard” in medicine is a clinical trial and few doctors will prescribe a course of treatment without seeing a specific study published in a reputable journal. Already there is a large body of scientific evidence for the use of supplements like Biocysan®, but to prove beyond the shadow of a doubt, we need to do this study. If successful, Biocysan® can be sold or even prescribed as a “Medical Food” that can help people at risk of kidney disease or already suffering the effects of kidney disease treat themselves with a low cost, highly effective treatment.
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) is a major health problem, with 26 million American adults suffering from CKD and millions of others at an increased risk. People with diabetes and heart disease also have an increased risk of Chronic Kidney Disease.
There are five stages of CKD; the final stage is called End-Stage Renal Disease (ESRD). At this stage, the kidneys are no longer able to remove enough wastes and excess fluids from the body. The 600,000 U.S. patients suffering from ESRD need dialysis or a kidney transplant.
ESRD is often accompanied by two blood disorders Oxidative Stress and severe Anemia, both of which are treated by Biocysan®.
Oxidative Stress & Anemia / Glutathione & L-Cysteine
Oxidative Stress, or high levels of free radicals, leads to damage to specific molecules with consequential injury to cells or tissue – kind of like rust, oxidative damage can destroy the normal function of important parts of your body. Oxidative damage has been associated with low levels of Glutathione (GSH), the most active physiological antioxidant present in the human body. For a great lecture on the topic, please watch Dr. John Richie discussing it here.
(editor’s disclosure, John Richie, Ph.D. was Alex Fair’s, the founder of this site, first graduate school mentor.)
GSH is instrumental for the synthesis of stable red blood cells, and essential in keeping red blood cells healthy and able to transport oxygen throughout the body, removing the threat of anemia (low levels of red blood cells).
International scientific publications confirm the importance of the role of L-Cysteine (a natural origin amino acid) as a precursor in the synthesis of GSH and its role as an antioxidant in ESRD patients and people at CKD Stages 3 and 4. Additionally, GSH levels are known to decrease in later stages of life, reflecting a need for supplementation in older, healthy populations. For more scientific references, please visit our literature page or see the links at the bottom of the page.
What is Biocysan®?
Biocyan® is a patented dietary supplement based on oral L-Cysteine – the GSH precursor in a pulse release formulation to counteract oxidative stress in CKD patients and alleviate anemia by re-establishing Glutathione levels. It has been available for sale over-the counter as a nutritional supplement with distribution largely in Europe.
L-Cysteine, the active ingredient of Biocysan®, is a very well known amino acid and it is considered GRAS (Generally Recognised As Safe) by the FDA.
No other oral Pulse Release formulations based on L-Cysteine are available in the market.
Biocysan® can help your red blood cells be healthier.
Biocysan® special Pulse Release formulation allows a continuous daily supplementation of Cysteine with relevant improvement to Glutathione levels in the body.
The Importance of the Biocysan® Upgrade to Nutraceutical (Medical Food)
Bio3 Research intends to perform clinical studies to upgrade the classification of Biocysan® from Dietary Supplement to Nutraceutical (Medical Food). The Nutraceutical labeling is important: physicians want to know that claims are real before recommending a product to a patient, and the labeling will help people acting without the advice of a physician to choose the right supplement since it has a clinical study to support its claims.
Clinical studies are aimed at satisfying the following FDA principles for a Medical Food:
• It is a specially formulated and processed product (as opposed to a naturally occurring food stuff used in its natural state).
• It must be consumed or administered enterally, either by ingestion or intragastic tube.
• It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation.
• The nutritional need could not reasonably be supplied by dietary alteration alone.
• It is intended to be used under medical supervision (i.e., by prescription).
• It is intended only for a subject receiving active and ongoing medical supervision wherein the subject requires medical care on a recurring basis, i.e., medical foods are intended for a diseased population.
• It is composed of ingredients designated as GRAS.
• It is based on recognized scientific principles.
We Need Your Help to Accomplish Our Goal
Bio3 Research seeks to raise $500,000 to perform a clinical study on a limited number of patients in specialized centers – as may be required by the FDA and other Regulatory Agencies – to validate the benefits of using Biocysan® (L-Cysteine). In addition to validating our earlier smaller studies, the proposed conical trial will allow Bio3 to officially claim that “Biocysan® plays an anti-anemic and an anti-oxidant role in Chronic Kidney Disease patients who show low levels of Glutathione in the body”.
Who We Are
Bio3 Research, Inc. is a US subsidiary of Bio3 Research, S.r.l., a development-stage biotechnology company that has developed Biocysan®. Additionally, Bio3 is also working on:
- Developing the protein HMGB1 for use in connective-tissue regeneration* (diabetic foot ulcer, healing of wounds, burns and bedsores, cartilage repair, bone matrix regeneration)
- Synthesizing HMGB1 fragments to inhibit/antagonize HMGB1, for use on cardiovascular diseases* (restenosis, arterial stenosis, treatment of atherosclerotic plaque progression).
Find us online here:
Biocysan®
Facebook
Email
NOTE: Bio3 Research plans to make donations to foundations which assist patients with CKD pathologies (e.g. AAKP and the National Kidney Foundation).
References
http://www.biocysan.com/literature.html
http://jn.nutrition.org/content/134/3/489.full
http://ndt.oxfordjournals.org/content/19/8/1951.long
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Have a question?
If the info above does not help, you can ask the project creator directly.
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