Bone marrow (30 ml) is aspirated under local anesthesia from the iliac crest of the patient and shipped to the cell therapy manufacturing center.
The German blood transfusion (DRK) in Ulm has standardized the production of clinical grade MSCs by using human derived platelet lysate in place of the standard fetal calf serum. Thus, xenobiotic substances are now avoided in the production of MSCs for patient safety.
The French Blood Institute (EFS) has also implemented the production of clinical grade MSCs in the EFS Cell Therapy laboratories. A closed system production process based on results from the French Society for Bone Marrow Grafts and Cell Therapy (SFGM-TC) was developed by the EFS in partnership with the company Macopharma in 2004. The process that was approved by the French regulatory agency (ANSM) is used for the production of clinical-grade MSCs in compliance with GMPs.
The production of MSCs is performed according to Good Manufacturing Practices (GMP) in well-defined culture media that does not contain xenogenic substances such as fetal calf serum (FCS). The European Cell Production facilities (DRK, EFS) have developed and validated a two step standardized procedure for producing hundreds of millions of MSC in 15 days by using human blood derivative (plasma lysate platelet, PLP) in place of FCS.
After quality controls, the cultured expanded autologous MSCs are packaged in a locked syringe. The syringe is then shipped to the clinical center. Autologous cells are seeded on the synthetic bone substitutes for a minimum of 60 minutes in the surgery room prior to implantation in the patient.