The Cells=Drugs Argument Has Suffered A Significant Blow


The Regenexx blog site has a fascinating article on tow approaches to reducing transplantation rejection. Osiris Corporation has tried to market a stem product that is a kind of one-size-fits-all stem cell approach for regenerative medicine. This takes mesenchymal stem cells from the bone marrow of young patients and concentrated them in a vial for use. Unfortunately, once these stem cells differentiate into other cell types, they are rejected by the patient’s immune system. While using mesenchymal stem cells from a different person can provide regeneration under particular circumstances, the transplants that use a patient’s own stem cells are always the best from the perspective of the immune system.

A study from Northwestern showed that kidney transplant patients who were also given transplants of bone marrow from the kidney donor did not require any immunosuppressive drugs to prevent the immune system from rejecting their new kidney. This shows that instead of stem cells in a vial (a one-size-fits-all approach to regenerative medicine), an individualized approach seems to be far superior. However, the stem cells = drugs dictum of the FDA argues for the stem cells in a vial approach. Unfortunately, in a Phase III clinical trial, Osiris’ Prochymal product spectacularly failed to provide relief to patients suffering from “Graft versus Host Disease (GVHD). Therefore the stem cells in a vial approach failed, but the individualized worked. This shows that the stem cells = drugs ideology is not one that is tied to reality.

To read Regenexx’s fascinating blog post, go here.