There is no doubt about the importance of fresh cells as a historical precedent for the modern lyophilised solutions. Without it, Cell Therapy would have been very different. However, the physician has to be conscious that fresh cells may contain the seeds of serious infections. This does not mean that animals used in the production of cell preparations should be carefully selected to ensure good health; there is not a single method that can assure the absence of animal pathogens with absolute certainty. Therefore, the previous state of the infectious disease (the incubation period) represents a serious threat to the patient’s health. The animal, yet “healthy” can host germs that may be hazardous to humans. Here are some of these cases of zoonosis below:
- Brucellosis Listeriosis
- Various Leptospirosis types
- Salmonella-related infections (typhus and paratyphus)
- Countless virulent diseases that may result in lethal encephalitis
It is no longer necessary to analyse the dangers of Fresh Cell Therapy after reading this long list. But Cell Therapy also poses other risks: it may cause allergic hypersensitivity reactions, at least for those with congenital susceptibility to allergies. What does this mean? Allergic reactions can cause serious illnesses that can lead to death, such as bronchial asthma, cardiovascular collapse, liver damage, skin inflammation and renal failure. Allergic encephalitis (brain inflammation) and allergic inflammation of the vocal cords, which both obstructs the airways are even more lethal.
Another disadvantage of the Fresh Cell Therapy method is the fact that fresh cells suffer self-dissolution after 15-20 minutes of autolysis. Not only does this reduce the therapeutic effect of fresh cell preparations, but they also contain biogenic amines (ptomaine’s), whose injection into the human body leads to poisoning.
All of the problems listed above have been solved thanks to advances in medical technology. Lyophilisation is the high vacuum process (also known as freeze-drying), in which water is removed from the cell material. This preserves the cellular substances for a practically unlimited time. The substances can be stored in finished blisters, which can be used as long as they are suspended in an aqueous, injectable solution (e.g. glucose). Once suspended, the dry cells are ready to be used in treatments, as their fine structures were not destroyed during the lyophilisation process. Since the preparations are stored in blisters, this allows the physician to dose the patient according to the severity of the condition or the aging process. Currently there are about 30 different cell preparations that can be used specifically for each disease. The use of lyophilised cells has several advantages.
- Easy to use
- Long expiration date
- Allows proper dosage
- Doesn’t cause allergic sensitivity in the whole organism
The ability to lyophilise the cells has allowed for a much easier transportation, ease of use of the cell suspension and longer expiry length. In fresh cell therapy the cells need to be kept in strict temperature ranges or denaturing of the proteins may occur, reducing the potential therapeutic value. A cell will undergo autolysis almost immediately after extraction from the donor animal. By drying the cells we prevent this autolysis from occurring, maintaining the therapeutic value of the cells.
By using the lyophilised cells, sterility of the cells can be almost guaranteed although we still screen all the cells for diseases before we inject them, allowing maximum safety. The animals we use at our labs are sheep, because they have a high predisposition to disease resistance and cancer resistance. The cells taken from the sheep, once lyophilised, have almost 100% of the proteins intact and are well tolerated by humans, causing allergic reactions to be almost none existent. In the unlikely event of a reaction, it has been localised to the immediate site of injection. Mild allergic reactions only occur in patients with predisposition to allergies and only in the area of the intramuscular injection. In this case, an increase of body temperature (up to 37.2° Celsius) is even a desired response of the body tissue to the therapy. The involved therapists never observed any allergic reactions in other distant organs. Therefore, the tendency to having allergic reactions is no contraindication to dry cell therapy; it is just the way the body has of assimilating this technique. Cell preparations in Germany are monitored by the state to extremely strict standards and studies performed by clinics have showed that lyophilised cells have the same curative effects as fresh cells.