Cell Therapy Safety & Certificates

Safety First

The cells are procured from the organs of special sheep. Favouring specially bred animals – spotted mountain sheep – as donor animals, is based on years of experience. This species of animal is very robust, has the lowest predisposition to cancer of all mammals and is highly resistant to bacteriological and virological diseases.

Dr. Bausch showing Lab Certificate

Dr. Bausch showing Lab Certificate

In accordance with the regulation, the sheep herd has been closed in the female line for more than 40 years, therefore avoiding the introduction of viruses or diseases. These animals meet the medical requirements for proper and safe application through the criterion of a closed herd of donor animals. The sheep donors are monitored by an official veterinarian and are subject to on-going veterinary control. They are also clinically examined and laboratory tested one day before they are used to extract individualised cells. Temperature, erythrocyte sedimentation rate and leukocyte count are among the measurements we take. Control measurements for cadmium, lead, quicksilver and other hazardous heavy metals are taken, as well as extensive viral antibody tests to ensure the tissue sample is to the highest standard.

Thanks to intensive breeding measures, the shepherd has succeeded in changing the animals’ biology, allowing the mother sheep that are pregnant for the first time to be at disposal (They will provide the cells for the therapy). Being in their 13th to 17th week of pregnancy, they are put in quarantine six weeks before they are to be used. This is the most convenient moment for collecting the cells because the development of the animal’s organs has been terminated. The German state has tight restrictions on the production and application of cell therapy, and our GMP lab facilities reach these high standards to prepare our patients’ cells under the supervision of our chief medical officer.

Lab Clean Room

Lab Clean Room

With regards to our cell production method we use lyophilised cells. These are fresh cells that have been extracted from the embryonic organs of the sheep. They then undergo the process of lyophilisation. This is effectively freeze-drying the cells to remove any water. Lyophilised cells are widely regarded as much safer than fresh cells. The main safety aspect of the lyophilized cells is that they can be screened for any microbes or toxins that could be harmful to humans, though this is not to say that our animals are not raised to the highest health standards. It is because some microbes carried by the sheep are part of the sheep’s natural biology, but will be detrimental to the health of humans, sometimes even fatal. By screening the cells we can remove these microbes. This is not possible with fresh cells, increasing the chances of contracting an unwanted disease. It is the view of our chief medical advisor that the lyophilized cells are the safer option, more effective and less prone to degradation.  In addition, all cell therapy studies and research publications done are based on lyophilised cells, proving that they work as effectively as fresh cell, with the advantage of being safer.

Certificates

We believe in total transparency when it comes to our services. Here is the list of the different Doctors, Clinics and Veterinary Approbations and Certificates for Cell-Vitalis Therapy (from the Institute of Regenerative Medicine). Feel free to click on each picture to enlarge the document.