The first of its kind, our quality and ongoing safeguarding process is the most important step for the safety and purity of the final (and future) product. No other corporation or academic organization engaged in the banking of mesenchymal adult stem cells does as much quality control or operates in as secure an environment as that deployed by Celltex. This is the leading edge of biosafety applied to regenerative medicine.
Our Banking Process
Significant tests are conducted and practiced rigorously to ensure a completely safe stem cell product. These tests include:
In order to ensure safety of banked cells, there should be no presence of parasites and toxins. Celltex conducts mycoplasma and endotoxin tests multiple times throughout the banking and cell culture process. Cells that are released from our facility our tested and checked to be contaminant free.
Sterility testing is necessary to show that the cells are free from any bacteria or fungi. Virus testing is also conducted during the banking process.
Cell Identification and Purity Tests
We ensure that the cells we deliver are, in fact, mesenchymal stem cells. There are markers on a cell’s surface that determine whether it is a stem cell. Cell differentiation is tested in vitro to positively identify mesenchymal stem cells.
It is imperative that as cells are cultured, or expanded, those markers are maintained. This will prove that the cells in the end product are the same cell type as the beginning material, ensuring they maintain all the characteristics of mesenchymal stem cells.
Cell Culture Analysis
During our process, we look for constant growth rather than inconsistent growth spurts or stops. We also ensure that the cells have the same shape and other characteristics throughout the growth process.
When a physician places an order with us, it is our job to make sure that the prescribed dosage is delivered. The Celltex process involves both manual and machine cell counting to verify the number of cells cultured.
We ensure all cells that are banked are live, active and viable.
Typically, in other procedures such as bone marrow transplants, a Human Leukocyte Antigen (HLA) test is conducted on a donor and recipient to see if they have matching antigens in order to determine if they are a good match for the transplant. We use HLA testing to confirm that the person receiving their cells are in fact receiving their own cells. The first step of the Celltex banking process involves a blood test that measures the patient’s HLA. When the cells are released, the HLA is taken from the cells to confirm the identity of the delivered cells.
To ensure no chromosomal changes, we randomly check samples to ensure that cells are unchanged genetically through growth and replication in the Celltex process.
This quality control test is conducted on random samples and looks to the DNA very intensely to discern any possible changes within the process. We look for and ensure 100% reproducibility. We keep the number of cell multiplication steps very low but are still able to achieve millions of identical stem cells through our patented process.