This past week a court ordered US Stem Cell to destroy the patient stem cell samples it has stored in cryopreservation. This is a very big deal for reasons that most people likely don’t yet fully comprehend. Why? US Stem Cell and others have long had culture expansion and banking services that were operating illegally in the US. There are many doctors and patients that have been using these stem cell storage services who are now in a tough spot. Let me explain.
Stem Cell Culture Expansion and Banking 101
Fat and bone marrow both contain mesenchymal stem cells (MSCs). These can be concentrated using both tissues through various lab processes. The process to isolate those cells from fat is illegal in the US without FDA approval. The process to isolate cells from bone marrow and use them in the same surgical procedure currently doesn’t require FDA approval.
When the stem cell faction of these tissues is isolated, they can be frozen down at that point and saved in cryopreservation. That means they can be stored (usually -150C) almost indefinitely and properly thawed using specialized lab technology. Once recovered from freezing, the cells can be used at a future date. This is very much like a bank where you make a deposit and later a withdrawal, hence the name.
The same thing can be done if the decision is made to grow the cells in culture after they are isolated. In that process, the cells are grown to bigger numbers first, usually over about two weeks and then frozen down. The only difference here is that you get many more stem cells to store.
There’s just one problem, freezing the cells and then using them clinically, regardless of which tissue is used or how that’s done is not legal without an FDA cell drug approval. However, that hasn’t dissuaded a number of companies from pursuing this stem cell storage business model. Only one of the many was US Stem Cell.
US Stem Cell and Cell Surgical Network and Culture Expansion
I identified a few years ago that both US Stem Cell and Cell Surgical Network were culturing MSCs and storing them in cryopreservation. Here are various blogs on that topic: American Cryostem FDA action (the group used by Cell Surgical Network), www.mystemcellusa.com , off-shore clinics offering culture expansion and banking, and US Stem Cell and SCIA ). Hence, these two clinic chains and others were part of a vast network of clinics that were using these services.
I have also identified a number of companies offering bone marrow stem cell banking. These companies were not culture expanding the cells but had the same regulatory issues. Meaning, the idea was that you would bank your cells now and use them in the future. However, from a U.S. regulatory standpoint, the ability to use those cells was in serious doubt because you would need a cell drug approval for each clinical indication for which the cells were used.
US Stem Cell Is Ordered to Destroy Patient Stem Cells
I have been warning doctors and patients for years not to get involved with these US-based stem cell culture and banking businesses. My concern was always that, once the FDA caught up with these companies, the patients would never be able to use these stem cells as advertised. Meaning, this would be like making an expensive cash deposit in a US bank that could never be withdrawn. However, what actually happened was so much worse than even I anticipated!
This week a federal court ordered that the patient samples that US Stem Cell has stored must be destroyed within 30 days. That means these patients made an expensive deposit in a US bank and not only can they never make a withdrawal, but the court just ordered that their deposit be wiped out.
What Does this Mean if You Are a Medical Provider or Patient that Fell for the Stem Cell Culture and Banking Song and Dance?
First, realize that my comments here only apply to these stem cell storage services that are operating in the U.S. Meaning, there are several countries out there that allow autologous stem cell culture and banking to occur. Hence, if you have cells banked in one of those countries, this doesn’t apply to you.
Second, there are at least 50-100 doctors who have recommended to hundreds (possibly thousands) of patients to have their stem cells banked. To these patients, I will say again, IT IS VERY UNLIKELY THAT YOU WILL EVER BE ABLE TO USE THESE CELLS! The same goes for doctors who are convincing patients to do this, please STOP!
The upshot? I have predicted this mess for many years, so I hate to say I told you so, but I just did. Do not fall for the sales pitch that you can legally grow or store your stem cells for future use in the United States. While that is possible in countries that allow that to happen, it is NOT legal here.