Description
ULSC Conditioned Medium (UCM) is produced aseptically from cultures of Umbilical Cord Lining Stem Cells (ULSC). UCM is a cell‐free product; it is spent medium harvested from the ULSC cultures and sterile‐filtered. As such, it contains exosomes, metabolites such as amino acids and nucleosides, growth factors, extracellular matrix proteins such as collagen, and proteoglycans such as hyaluronic acid.
The cells that are used to produce UCM are human adult mesenchymal stem cells derived from a segment of umbilical cord tissue from a single donor in accordance with Good Tissue Practices (GTP) and with informed consent. Donor eligibility was determined per 21 CFR Part 1271 Subpart C with screening and testing for HIV‐1 and 2, HBV, HCV, HTLV, Syphilis, WNV, CMV, and Chagas. No risk factor was detected in the donor, and donor testing was completed with FDA‐cleared assays in a CLIA‐certified laboratory. All test results were non‐reactive.
Additional safety tests have included cGMP tests of the ULSC line at later passages and have established that these cells are free of mycoplasma and of adventitious agents or viruses. Mycoplasma testing has been completed with assay qualification (mycoplasmastasis test) of cells and harvest media; results show that no mycoplasma is detected, and no inhibition (no interference with the assay) is detected. The in vitro adventitious agent assay (culture test) and PCR assays for human adventitious viruses (HAV, HBV, HCV, Parvovirus B19, CMV, EBV, HHV6, HHV7, HHV8, Enterovirus, Polyomavirus JC and BK, HPV‐16, and HPV‐18) have all shown no detectable adventitious agent or virus. All cGMP safety tests have been completed at a third party, FDA‐registered testing laboratory.
PROPERTIES AND DIRECTIONS FOR USE
STERILITY:
UCM is sterile‐filtered (0.2 µm) and aseptically filled in sterile vials, stoppered, and sealed.
QUALITY:
This product is Quality Control (QC) tested for Sterility, Endotoxin, Mycoplasmas, and Container Closure Integrity in accordance with specifications set by TheBioBox, LLC Quality Assurance (QA). QC testing is conducted at a third‐party lab in compliance with current Good Manufacturing Practices (cGMP). All test results must meet release criteria set by TheBioBox, LLC Quality System. UCM is supplied with a Lot‐specific Certificate of Analysis.
STORAGE:
Store at ‐20oC or below.
DIRECTIONS FOR USE:
UCM is for research use only. UCM may be supplied to manufacturers of cosmetic topical products that have signed the Restem Supply Agreement and have agreed to its terms. Manufacturers become responsible for downstream production, which may include any of the following: further processing, formulating with other components, additional testing, and/or labeling of final product. The intended use of UCM is as a raw material or as a final product for topical cosmetic use only and in compliance with current Good Manufacturing Practices (GMP) for Cosmetics.
LIMITATIONS OF USE:
THIS PRODUCT IS NOT INTENDED FOR INTERNAL USE, NOT INTENDED FOR INJECTION,
AND NOT INTENDED FOR HUMAN OR VETERINARY DIAGNOSTIC OR THERAPEUTIC USE.
