At the American Academy of Stem Cell Physicians, we strive to provide an industry standard for Physicians who use regenerative therapies in their research. This page is the current safety recommendations given by the AASCP for Physicians who are using biologics in their medical practice.
If you are using biologics in your research, whether you are using SVF, PRP, bone marrow, UCB, amniotic products, exosomes, xenografts, or peptides, there are key considerations to take into account to achieve the best safety for your patients.
- Communication with the Chief Scientific Officer from the laboratory you work with. Just talking to a sales agent is not sufficient enough when determining the quality of products for your patients. Sales agents typically do not have a medical or scientific background.
- If you are dealing with a company who cultures and expands their cells through the use of growth factors in the media, in particular, you may want to raise certain questions with the Chief Scientific Officer. ( a ) How many passages do they do when culturing their cells? What is the source of the biologics? (origin) It is well known that culture expansion beyond a certain threshold increased incidences of mutagenesis. Mutation of DNA is fundamental to cancer pathogenesis. Lab cultures expanding beyond 5 passages risk passing along exosomes with cancer stemness. Furthermore, as highlighted in the Tamanako article, neural stimulating factors used in culture media can trigger pancreatic cancer stemness. ( b ) Have you had any adverse effects over the past year? Past five years? ( c )What is your method of sterilization? ( d ) What is your method of shipping? ( e ) What kind of disease testing are you doing on donors? ( f ) Are you testing for bacteria or other contaminants before sending out your product? ( g ) Have you done any biological profiling on your product? ( h ) Have you done an immunoassay to verify immunomodulatory effects? ( i ) Are your products processed in an aseptic environment? ( f ) What is your current lab certification?
( g ) Who processes your products? What are their qualifications?
If you have any questions, please feel free to reach out to our Research Advisor.
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