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Is Cell Therapy FDA Approved?

Patients from the USA are rightly concerned about the quality and safety of the products being used. Treatment regimens that are administered outside the USA cannot be FDA approved. This does not mean that they are dangerous or even unregulated. Most countries have strict requirements that have to be met in order to produce and sell medical products and dietary supplements.

In Germany, most live cell extracts are produced and administered by the same doctor or clinic. The law allows medical practitioners to produce supplements and pharmaceuticals for use on their patients at their own facility. The local health office requires the facilities to meet stringent regulation standards when producing, mixing and administering medication. Facilities are inspected regularly to ensure that health and safety standards are upheld.

Cell Therapy products that are imported or produced in the USA are not intended to be used as drugs or to treat any specific ailment. For this reason, they are packaged and labeled for oral use only. The cell extracts are not injected, but held in the mouth for several minutes, allowing the contents to be absorbed into the body through the mucus membrane.

That being the case, these products need not be registered or approved by the FDA. They are packaged, sold and administered as nutritional supplements. The labeling indicates all information as required by the FDA.

For this reason, it is especially important to be selective when purchasing products claiming to be live cell extracts. Independent testing for many of these extracts has shown that they contain little or no active ingredients. When purchasing live cell extracts, it is recommended that you ask the supplier for the results of laboratory tests performed on their product showing the content of active ingredients.

Live Cell or Live Cell Extract Therapy- Which is Safest?

Live Cell Therapy

Live Cell Therapy is the use of live or fresh cells gained from animal embryos, embryonic material or very young animals. The donor samples are harvested and processed while the cells are still fresh. The selected organ is carefully ground into a paste. Much care is taken not to damage the individual cells. After processing, the cells are mixed with an electrolyte solution. This solution is then used for injection into the individual receiving therapy. The solution contains actual whole cells as well as cell parts and animal protein. The use of fetal donors or young animals reduces the risk of allergic reaction by the recipient.

Live Cell Extract Therapy uses organs from young or adult animals. The donor organs are ground to a fine paste in an electrolyte solution and mixed well. The cell structure is destroyed during this process. This solution is allowed to settle and is then filtered to remove any solid matter. Only the soluble parts of the cells, such as RNA and DNA, remain in the fluid extract. The solution does not contain any parts of the cell membrane or any animal protein. This process greatly reduces the risk of allergic reaction by the recipient. The filtration process also removes any viruses or bacteria that may be carried by the donor animal.

Which approach is safest?

Both Live Cell Therapy and Live Cell Extract Therapy are very safe to use. There were claims that Live Cell Therapy could expose the recipient to diseases carried by the donor animals. Also, there were supposedly reports of deaths due to allergic reaction in recipients while using Live Cell Therapy. This may have been the case in early practice, but current therapies show very little risk of allergic reaction due to careful preparation of the product and careful screening and monitoring of the patient. Animals used for Live Cell Therapies have to be bred and kept under very stringent monitoring by government health officials. The herds must be free of any communicable disease. A veterinarian regularly checks the animals and their organs are carefully screened before processing.  The preparation of the Live Cell Extract is done under sterile conditions in order to ensure its sterility and quality. Animals used for Live Cell Extract Therapy are reared in much the same way. Their organs are screened before processing and the organ extract is passed through a filter to remove any bacteria or viruses, after which the vials are filled in a sterile environment. Due to the diligent care taken in the production of these products and the preparation of the patient, side effects are very rare in either Live Cell Therapy or Live Cell Extract Therapy, making both methods safe treatment options.