As a former sales agent to a 1099 independent healthcare/medical sales organization (RIMEDIO.com) I would like to remain anonymous as I report these findings. They have contracted with AdvancedStemCellRx.com Ph: 800-632-3557 (who is partnership with US Stem Cell Clinic http://us-stemcell.com/ at 13794 NW 4th Street, Suite 212 Sunrise, Florida 33325 (954)-835-1500 email usstemcell@us-stemcell.com) to provide the sale force to promote adipose stem cell therapy under the guise of FDA regulation 21 CFR 1271.15(b) which states in part: "In regard to HCT/Ps from adipose tissue, we generally consider the exception in 21 CFR 1271.15(b) to apply only if the HCT/P from adipose tissue is for autologous use, is removed and implanted within a single operation or in a limited number of predetermined operations in order to achieve the intended effect, and does not undergo processing steps beyond rinsing, cleansing, or sizing. Limited handling such as rinsing and cleansing to remove debris would allow the HCT/P from adipose tissue to retain the structural function, while other processing steps such as cell isolation, cell expansion, or enzymatic digestion generally would not. Thus, if such other processing steps are performed that prevent the HCT/P from adipose tissue from remaining “such HCT/P,” the establishment manufacturing the HCT/P from adipose tissue would generally not be considered to meet the exception under 21 CFR 1271.15(b)." However, this company uses enzymatic digestion and/or cell isolation, cell expansion, which does NOT fall under the exception of adipose stem cell use. Therefore, I reported to, and strongly encourage the FDA to do an unannounced inspection of their facilities and review of their records to confirm or deny this activity for the general public safety of patients who could be impacted, as well as physicians who could be unknowingly and innocently culpable of their methodologies, which could put their medical licenses and practices at risk of violation of this FDA ruling. Additionally, for their Deepure Plus (cTCM herbal supplements) contract they promised to pay $65/call on 50 approved accounts. When I was the only agent that made any sales, they decided to cancel the contract because none of the other agents were making sales. Prior to doing so, they demanded "call notes" from each agent TWO MONTHS AFTER the contract began; without a clear definition of what constituted a "call." When they discovered that their definition of a "call" was not emphasized by the contract sales organization they were using to provide sales agent (RIMEDIO) they terminated the contract. Calls were made regardless of their definition and they owe me and other agents $3250.
