A new meta study has analyzed the safety of mesenchymal stromal cells (MSCs) from 1,012 patients in 36 studies from 14 countries around the world, with both adults and children and on a wide variety of diseases and conditions. The systematic study used both randomized as well as nonrandomized control trials and it appears to show the complete safety of these mesenchymal stromal cells, with the most common occurring reaction being transient fever.
The study is titled Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell): A Systematic Review and Meta-Analysis of Clinical Trials, and it indicates that mesenchymal stromal cells are in no way linked to dangerous diseases or fatal infections.
It confidently states that researchers were not able to identify any association between MSC treatment and any possible development of disease or abnormality, specifically “acute infusional toxicity, organ system complications, infection, death, or malignancy”. But there was a significant association between very short-lived fever after MSC had been administered.
Having systematically reviewed the randomized control trials (RCT) and non-RCTs, these results were confirmed by the researchers. They found that six out of seven RCTs and all the non-RCTs participating in the study described equal or fewer deaths with MSC treatment compared to the control treatment given. However it appears that the “completeness of adverse event reporting” in the study that were included was variable.
What is particularly encouraging is that apart from this transient fever, these current clinical trials suggest very strongly that the administration of MSCs is safe.
The cells used for the research study came from a wide variety of sources, both autologous as well as allogeneic. Sixteen of the studies used autologous MSCs, five used matched allogeneic and eight used unmatched allogeneic MSCs, while seven of the studies used a combination of matched and unmatched cells.
This is extremely significant for a number of reasons. Besides providing us with a much better understanding of the mechanisms of action of the MSCs in the body, and meaningful insight into how they appear to have limited cellular differentiation ability, the meta study shows how the MSCs home to inflammation sites. What makes this even more meaningful is the fact that more and more research is showing how inflammation is at the root of a number of diseases.
In addition to this, there are several other important findings that have been revealed by the study:
- The use of unmatched MSCs supports the contention of a number of other researchers that they are “immune-privileged”.
- It appears that the way they work is via immunomodulatory and paracrine mechanisms.
- They secrete bioactive molecules that make them especially effective when it comes to treating inflammation-based diseases.
- There was no association shown between MSCs and the formation of tumors.
This is a very exciting meta study that demonstrates what a number of researchers and clinicians have claimed over the past years. It strongly supports my own personal belief that stem cells are the foundation of a new multi-billion dollar industry that is going to transform medicine, cosmetics and new anti-aging technologies in the 21st century.