The PSC stem cell program is designed so that a one-time harvest of a small fat sample can provide the raw material to make a lifetime of stem cells doses. Stem cells can be grown in the laboratory so that this small collection can be multiplied into many billions of cells. This is one of the great characteristics of stem cells, that they can continue to grow and produce many cells. This is how they work in your body. We just use this quality to make your personal stem cell medicine chest, kind of like a compounding pharmacy.

In this review, we will highlight the stem cell manufacturing process that Personalized Stem Cells (PSC) uses with their mesenchymal stem cell (MSC) based therapies so you can get a glimpse of the very high quality standards for handling your cells.

PSC has established many stringent procedures and protocols to be able to multiple the number of stem cells for the culture expansion of your MSCs. These have been developed and optimized over 20 years of research and development. The steps include thawing frozen stored cells, plating these cells in special culture vessels, providing the best growth food for the cells, and then overseeing their growth and quality. The last step is freezing these stem cells in a special solution to protect them during the freezing and storing process.

We grow your stem cells under highly controlled and monitored conditions because, to be approved by the FDA for use in human trials, stem cells must be grown using what is known as Good Manufacturing Practice (GMP) standards. Setting up consistent and robust scalable manufacturing to meet regulatory compliance is an enormous challenge, but we have been able to do so successfully as a result of our decades of experience in stem cell manufacturing.

Under GMP standards, a cultured cell line has to be manufactured so that your cells are grown in an identical, repeatable, and sterile environment. We have incorporated consistent GMP manufacturing of MSCs starting with the initial harvest of your fat tissue, the raw material from which we make your stem cell doses. Cells are processed in a closed system of manufacturing that controls for potential exposure to outside contaminants. This way we can safely characterize and perform functional testing, quality control, and safety testing before releasing the cells for use. This ensures that each batch of your stem cells have the same dose and other properties, so that you receive an equivalent treatment each and every time.

A key part of this process is the Quality System. This includes staff with the purpose of overseeing the process, the cleaning, the records, and the testing. Audits are performed regularly as well as very extensive environmental monitoring to assure that the manufacturing facilities and equipment meet GMP standards. Every employee in the manufacturing facility is specifically trained on standard operating procedures and this training is documented and updated to assure the technicians are performing the procedures properly. Your tissue is identified and tracked at every step of the process from the fat harvest in the clinic, through shipping, all throughout the manufacturing and storage, and finally in the shipping to your doctor for your treatments.

Personalized Stem Cells – this means your cells for your treatment. GMP assures the highest quality in manufacturing of your cells. Check out this video!