Berlock

APS

Berlock

APS

Berlock

APS

History

 

Gorm Danscher
 

September 25, 2023
 

At the beginning of the present century a Danish TV program informed about acupuncture with small gold pieces used as a remedy of Arthrosis. 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 the method was another way of delivering gold ions than the ‘old’ gold-drug based treatment of rheumatism e.g., by intramuscular injection of Myocrisin® (Capell1988).

 

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, later called autometallography (AMG), it is possible to trace clusters consisting of only a few gold atoms.

 

A few years before nanosized gold particles had been introduced as a way of tracing antigen antibody connections in tissue sections. AMG made it possible to trace a billionth of a gram of protein marked with a gold particle. 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.

 

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

 

In the kidneys the proximal tubules of patients exposed to gold thiocompounds are intensely targeted.

 

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 Autometallographic technique is a quasi-photographic method that can be used to visualize nanocrystals of gold, silver, or crystal lattices of 1) zinc-Sulphur 2) zinc-selenium 3) mercury-Sulphur and 4) mercury-Selenium.

Specific methods for each of these crystals lattices has been worked out (Danscher and Stoltenberg 2006).

 

Autometallography causes the gold particles/nanoclusters 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 must be exposed to UV light before being AMG developed. The ultraviolet light reduces the chemically bound gold ions to metallic gold atoms that assemble 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 (Danscher 1981). 

 

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 be traced only at light microscopical levels.

 

However, a major problem, using colloidal gold particles as markers, was that the nanogold particles could not be observed at light microscopical levels (Horisberger and Rosset 1977). But combining the use of nanogold particles with autometallography gave the field of marking molecules with nanogold (antibodies, RNS and so forth) a major 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 cell.

 

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, Danscher and Stoltenberg 2006). 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 scientists engaged in bio-medical research, that implants made of gold were inert and that any response obtained by gold-acupuncture were essentially a placebo effects.

 

To ensure that 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). Sections containing the gold implants were the analyzed with AMG after being UV radiated. 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 in 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 that is well established for its key role in the formation of oedema.

 

Kidneys and liver know to be the first organs to take up gold in animals and humans that are exposed to gold drugs like Myocrisin were void of gold in animals injected gold implants, supporting the notion that all the released gold ions were taken up by cells in close vicinity of the implant, proving that the bio- released gold ions remain local making the technique safe.

 

Not surprisingly, AMG-stained cells around the gold micron-implants (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 thiocompound, however with the significant difference that the bio-released gold ions/dicyanoaurate ions all remain in a narrow zone around the injected 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 home in on the surface of the implant, in case 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 into it. 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 dicyanoaurate ions

(Au (CN)2⁻) 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. Canova, the local innovation company helped obtaining the necessary finances from the governments business authority (Denmark’s Erhvervsfremmestyrelse). Capnova was the state governance’s extended arm i.e., helped formation of the company and the control of the governmental support.

 

Super short on applications, activities, Patents and Companies:
 

Among important results is the scientific validation by Professor Sten Rasmussen’s work on osteoarthritis. He injected 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 collaborates 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 obtained a US patent “micron-sized gold kit for use as a nontoxic immune suppressor”. The patent is placed in AuroDerm ApS. This company has filed an application on golds oligodynamic effects on biofilms.

 

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. I.e., 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 devices’ has been filed in EU.  The patent is placed 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 placed 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 at Aalborg University are leading this research.

 

The EU patent “Gold particles for use in therapy to prevent scar formation” is placed 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.

 

At Sportsmedicinsk Center in Hjørring senior consultant Thøger Persson Krogh  run a clinical research program on the effect of µGold patients with Achilles Tendinopathy  (A clinical RCT-study of micro -gold implants pain relieving  effects sports injuries)

 

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 led 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.

 

 

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.  2008)

 

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