Some companies skirt regulations, opting instead to go off the radar. American CryoStem‘s Anthony Dudzinski‘s first words to me on the phone during our discussion were, “We follow the rules.” They’ve accumulated the greatest depth of adipose tissue-based cellular technology research relative to creating their laboratory and processes at a clinical cGMP level, and they’ve done it by actively engaging FDA consultants in the process.
They’re looking at adipose-derived stem cells – also known as mesenchymal cells. ‘Mesenchymal’ was the original name of cells that came from bone marrow, and the two types are 98-99% identical, but there are some difference with the protein markers and capabilities of adipose vs. marrow cells.
Marrow cells are better for blood-borne diseases like lymphomas, whereas adipose-derived stem cells seems to be much more effective than marrow for structural issues. The concentration of adipose cells per gram of source material is actually 500-1000x greater than bone marrow from same patient. They have the ability to differentiate into a multitude of other cells including chondrocytes. This has incredible potential for how doctors treat sports injuries and aging issues.
Anthony set the stage for the importance of the research,”Most sports or age injuries are due to ligament or cartilage damage to the extent that most of them are bone on bone. So what if we could take Mrs. Smith who’s 55 and played tennis most of her life but can’t play anymore and doesn’t want to have knee replacement surgery. We can take cells out of the fat in her own body, attach them to a scaffold to induce chondrocytes, insert them into the meniscal cartilage area, and as time goes by with normal rehabilitation, her body regrows cartilage in her knees and her pain is gone.”
Anthony is excited about the implications for creating tissue for repairs, wound healing, burns, tendon injury, etc., all coming out of cells taken from adipose tissue.
They hold the US patent for clinical grade cell culture media for these types of cells. It’s gotten them recognition within the physician network as the gold standard, but there are still some who want to extend American CryoStem’s capabilities beyond what is regulatorily sound. Anthony understands,”The FDA is overwhelmed and this business is moving way faster than they have the ability to keep up with. They sometimes drag their feet, but it’s important because it’s peoples’ lives.”
He goes on to say that the science of using your own cells on yourself does make it difficult to fit into the FDA drug approval process. What they’ve found is that every person is different: their cell count, cellular rate of growth, historical and familial disease tendencies, etc. There can be so many differences with growing a cellular sample. The cells themselves are easy enough to obtain and work with when you have the expertise, but 99% of the work is still at the bench, using research grade materials, and not ready for prime time. American CryoStem is still ahead of the game by a few years, though, as not many others have tried to commercialize a GMP-compliant method with the FDA
They can do this all in their own lab, but confirming the results in the laboratory that did the original work is not going to help them build a master file for the FDA. Once the master file is created, it can be used for all kinds of applications in the pipeline: clinical trials for multiple sclerosis, joint relief, osteoarthritis, pain relief, symptomatic treatments, repairs for ligaments, tendon, cartilage, bone, muscle, skin, and because these particular cells really are the structural repair cells in your body, even heart muscle.
Anthony described the attention American CryoStem’s gotten from researchers Rutgers, University of Washington, and the NIH, “We’re getting to the point as a company that we’re going slower but we’re doing it right. Science Exchange is a godsend. We get access to highly qualified core-tested technology without having to buy the equipment, do the verification or validation of unique testing we need, especially when it’s been done in other places. Part of our master file will be results from Science Exchange. We can then go to the FDA without a shadow of a doubt.”
About American CryoStem:
American CryoStem Corporation, a leading strategic developer, marketer and global licensor of patented adipose tissue based cellular technologies for the Regenerative and Personalized Medicine industry.
[about_box image=”https://d3l0iz7q6gnphu.cloudfront.net/assets/about/team/brianne-50bbf4c5982c228860a0aebe7b65590c.png”] Brianne is dedicated to customer support and development for Science Exchange. She is a formally trained biologist with a M.S. in Biotechnology whose past experience at Charles River Laboratories sparked a flame for building client relationships.[/about_box]