Stemedica is located in San Diego, California and its manufacturing facility is licenced and certified as Current Good Manufacturing Practices (CGMP) by the Food and Drug Branch, California State Department, monitored by the FDA.
Since 2005, Stemedica has become a global biopharmaceutical company led by prominent scientists, leading clinicians, and medical, biotechnological and pharmaceutical experts. Stemedica produces mesenchymal stem cells (MSCs) with a patented technology specifically used for research and clinical studies. With this technology, they were able to create a master cell bank from a single bone marrow extraction, commonly known as allogeneic stem cells. From this single donation, Stemedica is able to get approximately ten million treatments versus traditional technologies’ fifty to one hundred treatments. This assures that the stem cells will have the same level of quality, potency, viability, completely traceability and safety. To further verify this, numerous bone marrow samples were researched and narrowed down to the top one hundred. After which, different sets of tests were conducted searching not only for safety, genetic abnormalities, and viruses but also measuring the cells’ ability to differentiate into bone, cartilage, and muscle cells, just to name a few. Finally, one mesenchymal adult stem cell, derived from bone marrow tissue, was selected as the most versatile in differentiating between the cells tested in a body.
A very common concern for patients is: will my body reject the cells as they are not mine? The answer is no. The cells have an outside layer that your own body does not recognize as an external body. As a precaution, before every application we carry out a hypersensitivity test, where we inject a small portion of the final solution in your arm. This to rule out any allergies. The allergies may come from the solution the cells are prepared in, but the possibilities of this happening are very low and our medical team is prepared to act, given the case presents itself. So far, over three years’ experience, we have not witnessed an allergic reaction.
Presently, our treatments are composed by mesenchymal and neural adult stem cells. We are in consistent communication and compliance with Stemedica regarding their FDA-regulated stem cell products and clinical trial therapies.