First off, these products typically do not have any stem cells — yet these same doctors are touting the fact that the product does have stem cells. That leaves the Chiropractic physician open to claims of fraud.
Secondly, the FDA has stated unequivocally that if these products are to be used in the United States, they need either a Biologics license or an Investigational new drug application. Both entities are costly and time consuming, and currently none of these products have this classification. Thus, these products are in violation of the existing FDA guidance.
Fortunately, we now have We now have SIGMOLECS® Technology, which is an alternative that can allow the Chiropractor to become involved in Regenerative Medicine in keeping with the current guidance regulations and local state chiropractic boards. I, myself, have used this technology for the past several years on thousands of patients with superb results and essentially no side effects.
SIGMOLECS technology is an advanced chemical profiling through structural assembling of key molecules, mostly proteins and peptides, that form actuated molecules. It accomplishes this by specifically improving their bio-activity in solution and in vivo by increasing their transmembrane penetration. This creates precise specificity of action, particularly in intracellular signaling. This is essentially the method that the body uses to heal itself and is the essential basis of Regenerative Medicine and cytokine therapy.
SIGMOLECS molecules induce signals to key amino acid sensors that govern gene expression of amino acid metabolism that then trigger specific physiological and metabolic activity. The nuts and bolts of Sigmolecs molecules is quite simple. Sigmolecs® molecules are really like microchips carrying the information we want to program into the patient. So, once designed and synthesized Sigmolecs are put into a proprietary gel that delivers them trans-dermally, while at the same time causing essentially no reaction in the skin. We must also be cognizant of the fact that if you don’t have the right delivery system for your clinical application, even the most potent medicine will not work.
These SIGMOLECS molecules are structured according to key amino acid sensors to trigger specific regenerative tasks. This is done by grafting bioactive peptides or amino acid (AA) sequences onto a source molecule, usually a natural source of protein like Soy protein or Collagen peptides. This becomes the template for the Sigmolecs molecule that will be structured to have very specific bioactivity. Many of the mini-proteins found in plants are desirable for this work because of the resistance they contribute to enzymatic degradation, and their native structure provides a chemical template conducive to various sequence designs. Overall, this allows the synthesis of specific bioactive peptides while silencing signals and gene expression encoding undesirable processes; such as, proteinase secretion and expression of associated catabolic cytokines.
Sigmolecs® molecules are configured and assembled to mirror highly specific intracellular signaling factors. These are the same factors that stem cells and other regenerative cells utilize to accomplish repair of damaged tissue. They are essentially clones of what the body produces.
SIGMOLECS designer molecules are part of the delivery package; that is, the gel carrier. It contains Sigmolecs® Technology in that it designs scaled molecules that can easily penetrate the skin and enter deep tissue. The molecules are fashioned according to sequences that are ‘skin friendly’ and can facilitate navigation through cell membranes. For example, when using native peptides from suis collagen peptides the molecules provide a chemical template to structure therapeutic specificity in a repair combination. The basic gel amalgam provides structural molecules conducive to crossing skin and cell barriers, and in this sense, is a completely functional product that is both a carrier and a therapeutic gel in one. This gel enables the transfer of large molecules and solutes through cutaneous channels that normal dermal formulation or patches could not deliver. It allows penetration of large molecular weight molecules to cross the Stratum Corneum, deeply penetrating the epidermis and dermis, reaching vascular and cellular targets through tissue permeability akin to injection, but without any invasive needling.
There are two different type of products which are available in gel monodoses to be used with a patch. The first gel monodose is called the AI (ANTI-INFLAMMATORY) monodose which is upgraded to code for IL-10 and IRAP. These two entities are considered master anti-inflammatory cytokines. The raw material used to design the therapeutic Sigmolecs P3 AI gel is Soybean protein. This plant contains several small proteins that are already anti-inflammatory in nature, but more importantly, that are conducive to structural modification. Many drugs have been fashioned from plant molecules; most are proteins such as cytokines. Many come from Tobacco plant cell cultures, such as IL-2, IL-4 and the famed Neupogen otherwise known as G-CSF! Even Human Interferons have been successfully produced from plants, and many more human synthesized cytokines originate from plants.
The Anti-Inflammatory sequence provides vascular support, regulation of blood flow and platelet function, and very importantly, inhibition of inflammatory cytokines specifically, IL-6, IL-8 and TNF. It mediates the inflammatory response to prevent and reduce edema and pain while also contributing considerable analgesic effect without invasive pain procedures.
The RG REGENERATIVE MONODOSE GEL invokes cell differentiation especially to chondrocytes and keratinocytes. The raw material used to design the therapeutic SIGMOLECS® P3 RG gel is suis collagen. The peptides extracted from this source naturally regulate neutrophils especially in stem cell procedures while at the same time they stimulate and induce mobilization of transplanted adult stem cells. The SIGMOLECS® combination of structures in the P3 RG gel regulates the cell cycle particularly by signaling resting phase cells to migrate to areas of repair. It combats oxidative reactions in synovial fluid while stimulating chondrocytes to repopulate decellularized tissue at the site of injury. It also provides the extracellular matrix with signals, such as those that mimic hematopoietic cytokines, which reinforce procedures such as PRP and stem cells treatments. Furthermore, in Regenerative Medicine, the use of RG gel monodose post regenerative therapy will enhance the treatments by sustaining stem cell niches enhancing the success of clinical treatments.
Moreover, suis collagen peptides, in particular, are structured cleaner than other types of collagen which allows for a larger spectrum of sequencing for specific therapeutic action. These actions include sequences that mimic growth factor signaling such as Insulin Like Growth Factor (IGF) and Fibroblast Growth Factor (FGF.) The suis collagen peptides have more affinity for human synthesized growth factors than other collagen sources. The RG gel is particularly good to apply after a stem cell treatment. It will enhance treatment protocols by providing the regenerative cytokine signals and also provides the needed elements to the extracellular stem cell niche. It signals repair pathways while inhibiting TNF-override that often occurs during repair processes.
Please notice that the opinions in this article are solely my own professional opinions intended for professionals only.
Thank you,
Dr. Joseph Purita
These gel monodoses are now available for sale in the U.S.A to health care providers.
|
For details please contact:
Bob Colucci, at PuRxCell |
