Medical Disclosure, Disclosure of Liability & Refund Policy
Stemcellmia.com is a website designed for promotional & educational purposes only about Regenerative Medicine. The information provided on this site should not be used as a diagnosis or for treating a health condition or disease nor it is a substitute for professional medical care. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.
Disclaimer of Liability
Stem Cell Miami, LLC 7374 SW 93RD AVE, Suite 202 Miami Florida 33173 The medical services provided by Stem Cell Miami, LLC (“Stem Cell Miami”) are not intended as a permanent solution to the patient’s situation as natural degradation will occur over time. Though good results are expected, the possibility and nature of the complications cannot be accurately anticipated, therefore, there can be no guarantee expressed or implied either as to the success of the treatment. Stem Cell Miami is not regulated by the United States Food and Drug Administration (“FDA”). Stem Cell Miami practice and treatments are under the human cells, tissues and cellular and tissue based products (HCT/P’s) regulated solely under section 361 of the Public Health Service Act (PHS Act). FDA’s regulations set forth the criteria that must be met for an HCT/P to be regulated solely under section 361 of the PHS Act. These criteria are that HCT/P must:
- be minimally manipulated;
- be intended for homologous use only, as reflected in the labeling, advertising, or other indications of the manufacturer’s objective intent;
- no be combined with a drug or device, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or sterilizing, preserving or storage agent does not raise new clinical safety concern with respect to the HCT/P; and
- not have systematic effect and not be dependent on the metabolic activity of living cells for its primary function except if for autologous use, allogenic use in first-degree or second-degree blood relative, or reproductive use.
21 CFR 1271.10(a) FDA regulations further define “minimally manipulation” for structural tissue as “processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair or replacement.
21 CFR 1271.3(f)(1). For cells or nonstructural tissue, minimally manipulation is processing that does not alter the relevant biological characteristics of cells or tissues.
21 CFR 1271.3(f)(2) The injection of PRP is a procedure and therefore not regulated by the FDA. The procedures performed at Stem Cell Miami are done only through “minimally manipulation” of the cells and they’re not considered drugs. The United States Food and Drug Administration (USFDA) only regulates drugs. Stem Cell Miami is within the purview of section 361 of PHS Act and meets the minimally manipulation criteria set forth in 21 CFR 1271.3(f)(1) -(2).
Like all medical procedures, stem cell procedures have a success and failure rate. Patient has been made aware of the implications of undergoing a stem cell treatment at our facility. Therefore, it is Stem Cell Miami’s policy that no refunds will be offered once the procedure has been completed. Those patients who have paid their procedures in advanced, and that due to circumstances beyond their reach, are forced to cancel their procedure, a ten (10%) administrative fee will be applied to their refund. *Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.