None. Our aim is to make cell based medicine available to patients who are interested and to provide ongoing research data under approved Institutional Review Board (IRB) validated studies. We will follow our stem cell treatment patients over their lifetimes. This will enable us to accumulate significant data about the various degenerative diseases we treat. Instead of providing simply anecdotal or testimonial information, our goal is to categorize the various conditions and follow the patient’s progress through various objective (e.g. x-ray evidence or video displays) and subjective (e.g. patient and/or doctor surveys) criteria. We are aware of a lot of stories about marked improvement of a variety of conditions, but we make no claims about the intended treatment. At some point, once adequate amounts of data are accumulated, it might be appropriate to submit the information to the FDA at which point an actual claim may be substantiated and recognized by the Agency. Still, these are your own cells and not medicines for sale. They are only being used in your own body. Most likely, no claim needs to be made; rather a statistical analysis of our findings would suffice to suggest whether treatments are truly and significantly effective. We also hope to submit our patient’s data to an approved International Registry (See ICMS Stem Cell Registry) further fostering large collections of data to help identify both positive and negative trends.
