Our technology partner is American CryoStem in New Jersey. American CryoStem operates a state-of-the-art, FDA registered, clinical laboratory dedicated to processing, bio-banking, and the manufacturing of cellular applications using autologous (fat) tissue and adipose derived stem cells. The company’s processing and storage services operate in strict conformity with FDA regulation, the PHS act, Current Good Tissue Practice (cGTP), and Current Good manufacturing Practice (cGMP). There are multiple quality management protocols for sterility and cell viability and methodologies ensure a complete proprietary chain of custody monitoring. Samples are barcoded and examined at every stage of processing. This ensures that Cells On Ice clients are protected from the transmission of communicable diseases.
The collection of your adipose tissue is performed by your physician under local anesthesia in most cases. This minimally invasive procedure can be done in less than one half hour in your physician’s office or at a same day surgery facility. It’s simple, quick and the benefits can last a lifetime. The adipose tissue (fat) is compressed and placed into a special transport bag which is placed in a temperature controlled box.
Collected adipose tissue (fat) is transported under sterile conditions to our FDA registered laboratory immediately after it has been collected. Our laboratory utilizes state of the art equipment and methodologies to ensure the highest clinical standards are upheld. Adipose tissue (fat) is processed by enzymatic digestion into either SVF stromal vascular fraction or kept as whole fat for storage. SVF samples are tested for viability (ensuring live cells were collected) and sterility (free of contaminants) before storage, during storage and prior to sample release. For documentation, SVF cells are counted and a summary sheet is made of cells conditions and numbers.
Once processing is complete, the specimen is immediately placed into cryogenic storage at -190 degrees Celsius and safely stored in our cryopreservation tanks. FDA approved cryoprotectant enables adipose tissue and SVF to survive subsequent freezing and thawing. A specialized inventory control system is used to track specimens from collection to storage and future retrieval with a 24/7 FDA compliant monitoring system.