Stem Cell Technology
FDA Approved Stem Cell Lab
Systemic Laboratories operates a state-of-the-art, FDA registered clinical laboratory that serves physicians and is dedicated to tissue processing and bio-banking using a patient’s own tissue (autologous tissue) and adipose (fat) or bone marrow.
Our processing and storage services strictly adhere to FDA regulations, the Public Health Service (PHS) Act, Current Good Tissue Practice (cGTP) and Current Good Manufacturing Practice (cGMP) that are enforced by the FDA. These include multiple quality management protocols regarding sterility, cell viability, and methodologies to ensure protection from the transmission of communicable diseases.
Here is an overview of the technology employed in the processing and storage of stem cells:
Adipose tissue is collected during a mini-liposuction procedure performed by a physician in his/her own office or at a same-day surgery center. This minimally invasive procedure is typically performed under local anesthesia and takes about 30 minutes.
The adipose tissue is then deposited into a special transport bag, which is placed in a temperature-controlled box.
Next, the adipose tissue is immediately transported under sterile conditions to Systemic Laboratories’ FDA-registered facility, where we utilize sophisticated equipment and methodologies to ensure that we maintain the highest clinical standards.
Once the specimen has reached the laboratory, the adipose tissue is processed by a proprietary, compliant protocol into stromal vascular fractions (SVF).
Alternatively, the physician may elect to harvest bone marrow tissue from the patient. This can be uncomfortable compared to the liposuction process sued to extract adipose tissue.
Once processed, SVF is sent to the physician(s) for deployment, and additional samples are placed in cryogenic storage at a temperature of -80 degrees Celsius which can be retrieved from the cryo bank as needed for future use. Samples are tracked from the collection, storage, and future retrieval with compliant inventory control and monitoring system.