Berlock

APS

Berlock

APS

Berlock

APS

History

 

How a TV program led to science-based use of µGold for suppression of autoimmune inflammation in human and veterinary medicine


Gorm Danscher

April 14, 2021

At the beginning of the present century a danish TV program presented acupuncture with small gold pieces. As there are no scientific evidence for the effects of acupuncture, the only possible explanation for the claimed effects of placing the small pieces of gold into the acupuncture points was, that gold ions were released from the 1 mm pieces of gold tread.  I.e., that it was another way of performing the gold-drug based treatment of rheumatism e.g., by intramuscular injection of Myocrisin® (Capell 1988). Otherwise, the effects could only be interpreted as placebo.

In 1981 I developed a technique for light and electro microscopical tracing of gold in tissues sections (Danscher 1981). With this technique it is possible to trace clusters consisting of only a few gold atoms. This, among other things, made it possible to trace a billionth of a gram of protein in tissue sections. In blots, as little as 0.1 pg. of a target IgG   has been detected by AMG, and the technique has proved highly sensitive in detecting nanogold marked biotinylated nucleic acid probes in in situ hybridization.


Using AMG on tissue sections from experimental animals treated with aurothiomalate (Myocrisin®) revealed gold uptake in a lot of different cells all over the organism.


The kidneys have been found to be in particular intensely targeted when patients are exposed to gold compounds and at large doses of e.g., Myocrisin® can cause death (Lawrence 1953).


Another, less serious, effect of treatment with gold containing molecules is that ensuing exposure to sunshine causes the chemically bound gold ions in fibroblasts of the skin to be reduced to metallic gold atoms that collects in tinny nanoclusters of gold. Situated as they are in fibroblasts these clusters cause a grayish coloration of the skin (Svenson and Theander 1992)


The 1981 technique, later named autometallography (AMG), is a quasi-photographic method that by means of co-application of quantitative analytical methods, can be applied for tracing of additional metals like silver, zinc and mercury. Specific methods for each of these metals has been worked out (Danscher and Stoltenberg 2006).


Autometallography causes the gold particles to be encapsulated in metallic silver whereby they grow to sizes visible in the light microscope. If the gold ions are chemically bound in the tissue, what they normally are, the sections have to be exposed to UV light before being AMG developed. The ultraviolet light reduces the chemically bound gold ions to metallic gold atoms that auto collect in nanoclusters (Danscher 1981). The idea of using UV light to make, the otherwise invisible chemically bound gold ions, ‘visible’ to the AMG technique came from an understanding of the sunshine problem of gold treated patients. 


Until a clever Canadian scientist developed an EM technique that marked specific antibodies with nanogold (40 -60 nm) the only way of tracing specific antigens or other molecules histochemical, was to use fluorescing molecule which can only be traced at light microscopical level.


A major problem, using colloidal gold particles as markers, was that the nanogold particles could only be observed at ultrastructural levels i.e., in the electron microscope (Horisberger and Rosset 1977). But combining the use of nanogold particles and autometallography gave the field of marking molecules (antibodies, RNS and so forth) at LM and EM levels, a further lift (Holgate et al. 1983, Danscher and Nørgaard 1983) 

It was suddenly feasible to use far smaller nanogold particles (down to 1-2 nm) and the position of the marked molecules could be studied at both light and ultrastructural levels in the same tissue section.


Semithin plastic-embedded section are AMG developed and analyzed in the light microscope. Thereafter the sections are re-embedded on top of an Epon block and ultrathin sections cut and counterstained. These are then analyzed in the electron microscope i.e.  the same cells can be scrutinized at all possible magnifications (Danscher 1981, Danscher and Nørgaard 1983; Hainfeld and Powel 2000). The technical development meant that several companies started to produce and sell AMG developers e.g., (www.Nanooprobes.com).



Bio-release of gold ions from metallic gold (Danscher 2002). 


It has been established that gold, soluble only in aqua regia, is insoluble in the living organism. For this reason, I initially believed, like most people engaged in bio-medical research, that any response obtained by gold-acupuncture were essentially a placebo effect.


In order to ensure that the gold implants did not interact in any chemical way with the surrounding tissue the millimeter sized gold implants used by doctors and veterinarians was placed into numerous locations, including the brain of rats (Danscher 2002). The astonishing result was that cells, in a narrow range, around the implants contained AMG traceable gold. At ultrastructural levels the AMG-amplified, gold nanoclusters were found to be localized to lysosomes of the dissolucytotic macrophages, fibroblasts and mast cells (Danscher 2002). Additionally, gold particles were observed in the secretory granules of mast cells.  These granules are known to contain histamine – well established for its key role in the formation of oedema.


AMG analysis of sections of kidneys and liver from gold implanted animals, the first organs to accumulate gold ions in Myocrisin® treated experimental animals, were void of AMG staining, supporting the notion that all the released gold ions (dicyanoaurate ins) remained in the close vicinity of the implant.  This observation indicate that gold implantation is a safe technique for animals and man.


Interestingly, AMG-stained cells around the gold implant/µGold were the same types as those AMG-stained after systemic treatment with Myocrisin®, i.e., macrophages, fibrocytes and mast cells (Balfourier et al.2020). This demonstrate that local gold implantation/µGold injections are comparable to the systemic treatment with a gold compound, however with the significant difference that the bio-released gold ions/dicyanoaurate ions all remain in a narrow zone around the site of injection of the µGold.


In the first article, and in a substantial number of later articles, it was established that gold ions are liberated from the surface of gold implants by a process termed dissolucytosis e.g. (Larsen et al. Locht et al. 2009, Deisenroth et al. 2013, Seifert et al. 2012, Zainali et al. 2013)


Macrophages identify and converge on the surface of the implant in casu µGold particles, creating a nano-thick membrane coined ‘dissolution membrane’ between themselves and the gold surface. The macrophages control the chemical milieu in the membrane including release of cyanide ions. This special environment causes an oxidation of gold atoms to monovalent gold ions that further interact chemically with the cyanide ions creating dicyanoaurate ions. From the dissolution membrane the Au (CN)2⁻ ions flow out into the intercellular space.


The dicyanoaurate ions are believed to bind to proteins in the intercellular space and to surface proteins of macrophages, fibrocytes and mast cells. Subsequently, the now gold containing proteins are taken up by the cells and accumulated in their lysosomes. A hypothesis of how gold ions end up in the secretory granules of mast cells has still not been worked out.  


It has been observed that if the tissue is in a state of inflammation when the micron-sized gold particles are injected, or alternatively, if the inflamed tissues already contain gold particles, larger quantities of dicyanoaurate ions, are released as compared to tissue not affected by inflammation (unpublished Danscher 2018). The reason for this effect has not yet been determined but is likely related to the significant increase in the number of macrophages associated with inflammation.  



Patent opportunities


The first experiments were carried out in 2001, a time where the government had just appropriated the scientist’s rights to their inventions. For this reason, it was necessary to forward the 2002 article to the newly created patent committee at Aarhus University.  The committee determined that the findings did not qualify as an invention, but rather a discovery, and concluded, upon supported consideration, that it in fact belonged to the researcher and did not require payment of fees or interest to the University if the discovery was later commercialized by the author.


In 2002, a company called Berlock ApS was created. This was made possible

by a dynamic innovation environment, Capnova, located in Aarhus, and the necessary finances were obtained from the governments business authority (Denmark’s Erhvervsfremmestyrelse). Capnova was the state governance’s extended arm i.e., the formation of the company and the control of the governmental support was at hand in Capnova’s auspices.



Super short on applications, activities, patents and companies:

Among the results that are moving rapidly towards scientific validation, are Professor Sten Rasmussen’s work on osteoarthritis. He injects BMI, i.e., µGold particles (99.99% pure gold, 20-40 microns) suspended in hyaluronic acid or the patient’s own joint fluid, intraarticularly into patients suffering from osteoarthrosis. He has treated 230 patients until now. Sten Rasmussen collaborate with several other scientific groups in Aalborg. Knowledge about the effects of metallic gold on inflammation is partly based on studies on experimental animals an empiric reports from animal and human patients suffering from osteoarthritis.


In 2018, Berlock ApS received a US patent “micron-sized gold kit for use as a nontoxic immune suppressor”. Berlock ApS has entered into a contract with an American company, ‘Gold Flex Life Sciences, Inc’. The contract covers the “autoimmune suppression of gold” part of the above patent.


Additionally, a Danish company, Gold Treatment ApS, has a contract covering the same topic in Europe, but for animals only.


Another interesting aspect awaiting scientific validation is our finding that foreign bodies, e.g., microchips or sensors do not stray from their site of implantation/injection. That is to say, they remain where they are placed.


It is a scientific fact that gold/dicyanoaurate ions inhibit/block inflammation. A foreign body causes small foci of inflammation along its surface. As Inflammation always include oedema, the small short-lived inflammatory foci are accompanying by oedema that causes the foreign body to move around. Over time, these small movements accumulate and result in quite significant deviations from the point of introduction of the implant.

If metallic gold is added to the surface, the coming and going of inflammatory foci along the surface will stop/not arise and the implant/foreign body therefore remain on site.


A patent, entitled “Implantable device having an outer surface comprising gold and its use as an anti-migration device” is scheduled to be approved in US and EU within a few months.  The patent will be located in Safe Implant Technology ApS.


We also know that hernia-mesh and breast-prostheses, when introduced into the human body, trigger inflammation and proliferation of granulation tissue, a process that result in formation of a connective tissue capsule around the implant. If metallic gold is added to the surface of the mesh or prostheses a radical reduction in the amount of granulation tissue will result. This causes the capsule to be and stay thin and containing primarily delicate collagen fibers. Capsule induration after “gold treatment” of e.g., mesh, breast-prostheses is therefore highly unlikely. 


The patent is titled “Gold particles for use in therapy to prevent or reduce capsular contracture” and is located in Safe Implant Technology ApS.


We are also conducting scientific studies into the effect of gold on wound healing. Gold is known empirically to minimize scar formation. Professors Sten Rasmussen and Lars Arendt-Nielsen at Aalborg University are leading this research.


The patent application “Gold particles for use in therapy to prevent scar formation” that will soon be granted in EU and within half a year in US. The patent is located in ReGold ApS. 


As with mesh and ‘soft prostheses*, metallic gold significantly inhibits granulation tissue in a wound. Gold moreover is known to exert an oligodynamic effect. That is to say that gold has inherent bacteriostatic/bactericidal effects that support wound healing. The ongoing research in this field also includes experimental and clinical studies of gold’s inhibitory effects on keloid and hypertrophic scar formation. Professor Bjarne Møller-Madsen, Aarhus University Hospital is leading this research.


På Sportsmedicinsk Center i Hjørring begynder Overlæge Thøger Persson Krogh snart et kliniske studium af micrngolds indvirkning på bl.a.  achilles tendinopatier (Klinisk RCT-studie af mikro-guldimplantaters smertelindrende virkning på sportsskader)


A


Hip and knee protheses and stents


Improved fixation and reduced pollution from the alloys that ‘hard protheses’  are made of can be obtained by adding  metallic gold the surface of the prothesis.


A new way of protecting the organism from toxic metals leaking from stents, prostheses and other implants involve gilding /gold patching /or gold amalgamation of the surfaces of the devices.


Metal ions are known to be released form metallic surfaces placed in tissues by a process coined dissolucytosis (Danscher 2002, Larsen et al. 2008, Danscher and Larsen 2010, Jakobsen et al. 2010, and several more). The bio-release of metal ions is generated by macrophages attacking the metallic foreign body. As mentioned earlier the macrophages first establish a membrane, the ’dissolution membrane’, between themselves and the metal surface. It is in this membrane the chemical events take place that lead up to the release of charged metal ions into the membrane.


From the dissolution membrane the metal ions diffuse out into the surrounding tissue and if there are no inhibiting gold ions to control the macrophages and terminate the inflammation the amount of released metal ions will soon be so massive that the surrounding tissue cannot bind them and the metal ions will spread, through blood and lymph vessels, to the whole body.


But back to the stability of the prosthesis-bone fixation. Over time the metallic surfaces ignite small foci of inflammation that flares up and die out. Just as on the surface of mama substitutes. But in bone fixed prostheses the jumping spots of inflammatory foci along the bone-prosthesis zone will cause a replacement of bone tissue with loose connective tissue. Over time this process will cause a loosen of the implant that ultimately result in reoperation.   


A way of avoiding the above processes is to have points of metallic gold along the tissue/bone interface. Such spots of gold will switch of the inflammatory process and prevent creation of loose connective tissue.


Conclusion: Gilding of implants (stents, hearing aids and the like) or gold patching/gold amalgamation of their surfaces will improve the fixation and, at the same time, minimize release of toxic metals to the organism. The prothesis will therefore remain safely anchored in the bone and no toxic metals will be released into the body.



Metallic gold imbibed contact lenses


In eyes suffering from allergic and autoimmune inflammation macrophages are manifold present. If contact lenses incorporated with bio-available metallic gold are applied to such irritated eyes the macrophages will attack the gold surfaces and by dissolucytosis release gold ions into the tear fluid. The dissolucytotic macrophages will be influenced by the gold ions whereby the cascade of immune events that we call inflammation will be suppressed. Metallic gold containing contact lenses can be safely used in healthy normal eyes also and can therefore be used prophylactic to suppress inflammation at an early stage. In the normal eye the number of macrophages is low and the release of gold ions therefore minimal.



µGold influence on brain lesions, multiple sclerosis and Alzheimer’s


Based on several studies of the effect of µGold the brain lesions (Danscher and Larsen 2010, Larsen et al. 2013) new research on micro

golds impact on Alzheimer’s is planned to take place in an USA-Australia collaboration lead by Professors Frederickson and Ashley Bush.  

Studies central to the work:


1) Gold ions bio-released form metallic gold particles reduce inflammation and apoptosis and increase the regenerative responses in focal brain injury (Larsen et al. 200


2) ‘Metallic gold treatment reduces proliferation of inflammatory cells, increases expression of VEGF and FGF, and stimulates cell proliferation in the subventricular zone following experimental traumatic brain injury’ (Petersen et al. 2009).


3) Metallic golds slows disease progression, reduces cell deathe and induces astrogliosis while     simultaneously increasing stem cell responses in an EAE rat model of multiple sclerosis. (Pedersen et al. 2012)



April 14, 2021