STEM CELL THERAPY

Are there any known side effects to adult Stem Cell Therapy?

Side effects are typically minimal and may include minor pain and irritation at the injection site. Since we are using a patient’s own stem cells, chances of immune system rejection are extremely low.  Extensive research and testing using adult stem cells is ongoing worldwide, very few adverse events have been reported Scroll up

How long will my recovery take?

Our procedure technique is minimally invasive and patients walk out within 3 hours in most cases. As a result recovery time is very quick. Many patients will experience soreness for a couple of days to a week, but there are usually no restrictions regarding resuming normal activity Scroll up

FDA EXCEPTION

Is this procedure (FDA) approved?

No, it is not; because it falls under the category of Physician’s Practice of Medicine, wherein the physician and patient are free to consider their chosen course of treatment. Our clinical application of mechanically isolated ASCs during the same operative session with minimal manipulation, however, is categorized as practice of medicine and thus allowed. Our procedure is compliant with the U.S.Food & Drug Administration (FDA) Code of Federal Regulations no. 21 Part 1271. We meet FDA regulations by providing a same-day procedure done entirely in clinic with the patient’s own cells which are then immediately delivered back to that patient. See FDA Guidance

For treatments that truly provide an impressive benefit to patients, the FDA does not require larger studies than are needed to prove that benefits outweigh risks, and when benefits are dramatic, trials for regulatory approval can be modestly sized. For example, a statistically significant 100% improvement in an outcome measure (α=0.05, β=0.1) could be detected with a randomized trial involving as few as 42 participant. The FDA is committed to facilitating the development and ultimate licensure of safe, effective stem-cell therapies. According to a statement from the FDA: "Stem cell therapy is a complex and emerging field of medicine” Scroll up

THE EUROPEAN PARLIAMENT

Our Stem Cell Procedure and the European Parliament

Pre-clinical and clinical studies in diverse fields followed the discovery that Adipose-derived stem cells ADSCs were not only precursors to adipocytes, but also readily underwent expansion and had the capacity to undergo adipogenic, osteogenic, chondrogenic, neurogenic, and myogenic differentiation in vitro. Moreover, because ADSCs do not require extensive manipulation before application, there is no requirement for “cell manufacturing” compliance in accordance with the European Good Manufacturing Practice (eGMP) Guidelines. These restrictions are not applied in case of minimal manipulation [Regulation (EC) No. 1394/2007] of the European Parliament and the Council]. Therefore, the development of high-yield isolation technologies with minimal handling for ADSCs would be highly desirable for clinical applications

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