An elderly woman in Australia reportedly died shortly after receiving a fat stem cell transplant.
Sheila Drysdale passed away hours after getting an adipose stem cell treatment a few days before Christmas in 2013. That death is now being investigated by the coroner there.
Not only is this death in Sydney distressing in it of itself, but also it raises broader safety concerns across the globe including here in the U.S. because fat stem cell treatments of this kind are so widely administered. Most have not been approved by the various countries’ regulatory agencies including the FDA here in the U.S.
This kind of “liposuction stem-cell therapy” procedure is often marketed by stem cell clinics as safe and effective for a host of conditions.
The AAP article that reported the death provides more details:
“… in July 2013, Mr Drysdale heard an advertisement for Macquarie Stem Cells, whose celebrity patients included the late model Charlotte Dawson and cricket legend Geoff Lawson, and began investigating the possibility that stem-cell therapy could help his wife after reading about encouraging US case studies online.”
This part of the report also highlights how what goes on in the U.S. has global implications for patients and the stem cell field.
Mr. Drysdale, who himself got a stem cell therapy for arthritis, indicated that he recalled the clinic doctor downplaying risks. It is common in the U.S. as well for clinics to indicate that there is little-to-no risk from stem cell treatments, when in fact there are documented potential risks. According to the article:
“He said look, you had it done to you, it’s no big deal,” Mr Drysdale told the inquest on Tuesday of a conversation with the doctor performing the surgery, Ralph Bright.”
Even amongst some academics in the U.S. there has been a growing mantra that adult stem cells such as adipose mesenchymal stem cells (MSC) are by definition always safe, but such a broad assumption should not be made given many factors: (1) the wide range of types of adult stem cells, (2) the often scant stem cell training of practitioners, (3) treatments being given outside the area of physician speciality, (4) the range of laboratory conditions and devices used, and other issues such as differences in patient’s already existing medical conditions and health status.
From a broader view, efforts in the U.S. and elsewhere to weaken stem cell regulatory oversight that covers adult stem cell therapies including fat stem cell treatments could endanger patients both here and around the world as many countries could follow this path. Update: To be clear, given the circumstances I doubt that the actual stem cell product caused the death and it is more likely the procedure itself.
The investigation of the death in Australia, which hopefully will clarify what actually happened and if the experimental stem cell therapy procedure played a role in the outcome, points to just how high the stakes are here. Other deaths and negative outcomes (e.g. here, here, and here) related to stem cell offerings have been reported in recent years as well, further raising concerns more generally.
http://www.dailytelegraph.com.au/newslocal/liverpool-leader/a-liverpool-based-doctor-under-investigation-after-surgery-death/news-story/b98a51f325356cef16cfb31636faea99
No medical treatment is totally safe – all drugs and medical procedures come with risk or death.
It is likely that this was a liposuction event but this is unknown without having the complete facts reported rather a journalistic headline.
To clarify the above comments we have to be careful as to what stem cells we are referring to; are we referring to stromal vascular fraction, autologous MSCs, or allogeneic MSCs this will define the risks of immune activation – a blanket statement of dangerous stem cell clinics is incorrect unless you can clearly define what cells they are using.
Any death is a tragedy to all the people involved but as scientists/doctors we should ask the real question – what is the treatment risk in comparison to the standard medical procedure.
Liposuction risk – FDA website – Some of the studies indicate that the risk of death due to liposuction is as low as 3 deaths for every 100,000 liposuction operations performed (0.00003%). However, other studies indicate that the risk of death is between 20 and 100 deaths per 100,000 liposuction procedures. So it is quite low but it does happen.
Risks for adult stem cell therapy on joints such as knees can be based currently on the literature available. Overall there are greater than 40 scientific publications with over 20 publications for bone-marrow derived cells (3,500 patients); and 20 publications for ASCs and SVF (total 1,500 patients) which puts the number above 5,000 patients (and yes I am able to provide the references for the literature). Lets assume which may be incorrect that the cells or associated procedures caused the death, and then lets throw in the other death Paul mentions for good measure. This is 2 per 5,000 (0.004%) known deaths. It will be argued that there could be unreported deaths – quite possible but I am sure the journalists would have had their fun with it.
As far as I can determine the risk for knee replacement surgery for death is approximately 1 per 400 within 30 days (0.25%), with serious complications less than 1 in 50 (2%). In 2010 there were 244,000 knee replacement surgeries in the US – that makes 610 deaths (1.6 deaths every day). But this is expected deaths in hospitals and are just part of statistical events and not worthy of reporting.
Should the real headline read ” Cell therapy 6x safer than knee replacement surgery for joints.” Safety should of course be discussed with whether it is efficacious or not – this is for another time as space is running out.
@admin – “Stem cell clinics here in the U.S. and elsewhere often state that there is little if any risk from the procedures that they do and market…” Could you please share the information that led you to this conclusion? Otherwise it’s nothing more than mere speculation. Regarding the risk of less regulation, we don’t have to rely on your “belief”. We can just watch Japan, which has already implemented a system for bringing stem cell treatments to market after preliminary safety studies are completed. There is no need for speculation.
“Our technology allows us to complete the entire procedure in the same day…and what is more important TOTAL SAFETY” (www.startstemcells.com/stem-cells-treatment-procedure.html) (their emphasis)
“Because we only use cells that come from your body, the risks of allergic reactions and rejection are eliminated.” http://celltexbank.com/en/therapies/ (I guess there is no such thing as an autoimmune disorder in Texas!)
Took me 2 minutes to find these. There are many such statements from stem cell tourism clinics and all are generic, misappropriated and misleading.
The Celltex statement is true. Your body does not reject its own cells. So you found 1 in two minutes. Thanks for got definition of “often”.
“Your” not “got” and I wasn’t asking you. I was asking @admin.
That’s incorrect Bill. In autoimmune diseases, like diabetes, lupus, psoriasis, and many others, the body does attacks its own cells – hence AUTO-immune. This is a consequence of the failure of immune tolerance. More relevant to stem cell therapy is innate immune activation due to injection of damaged stem cells, which the body interprets as a wound.
There are clear reports of immune activation after autologous stem cell treatment.
The body does not reject mesenchymal stem cells, even allogeneic ones.
That’s what unregulated stem cell clinics say too, but published data demonstrates that MSCs can be rejected by the immune system.
“…recent studies describing generation of antibodies against, and immune rejection of, allogeneic donor MSCs suggest that MSCs may not be immune privileged.” Ankrum JA, Nature Biotech 32:252–260 (2014)
“..the majority of studies has documented specific T-cell and B-cell immune responses against donor antigens following administration of non-manipulated, interferon-γ-activated and differentiated allo-MSCs”, Griffin MD. Immunol Cell Biol 91:40-51 (2013)
@Jon,
Thanks for tackling that myth that MSCs are never rejected. There are a number of other myths such as that MSCs are always safe and can never cause tumors. Such absolute statements just don’t work in an area where there are so many variables.
I agree that there are places, like one of the two you cite, that should not be making claims that are obviously untrue or grossly exaggerated.
I think that it is important to note here that providing information based on an interview is misleading (as it is only a one-sided interview). It is unfortunate that a person of your standing within the community is scaremongering people. By doing so,you are actually coming across as being arrogant and taking advantage of a situation for the benefit of trying making headlines for your followers. As a follower of your blog I am not only disgusted but also appalled that you are capable of such doings. Your ethical conduct is one that should be questioned!!
@Shelly,
A lady died right after getting a dubious stem cell treatment. That’s a fact and very serious. I addressed this situation in a sober manner and placed it in the proper broader context of people today pushing for less regulation of stem cell treatments at a global level, which I believe would be very risky. I don’t see the scaremongering. I also indicated that the coroner would hopefully determine the cause of death. Stem cell clinics here in the U.S. and elsewhere often state that there is little if any risk from the procedures that they do and market, which is a big selling point. This kind of news story provides important context for evaluating such claims.
http://www.abc.net.au/7.30/content/2014/s4089015.htm
It was probably the lipo.
That’s was my first thought as you may have noticed in my comment. Someone in her condition should not have been having an invasive procedure in my opinion. Medical malpractice undoubtedly.
@Paul,
In all fairness, you should mention that it could very well be that this death was related to the surgical procedure not the stem cells:
“After Mrs Drysdale was returned to Warriewood, the inquest heard, there were three telephone conversations between nurse Sharleen Zvatongwa and Dr Bright in which Mrs Drysdale’s vitals were relayed to the doctor.
“He said she was recovering, just let her sleep and she’ll be all right in the morning, and on that basis I left,” Mr Drysdale said.
But about 15 minutes after Mr Drysdale left the aged care facility, Mrs Drysdale had no pulse.
Mrs Drysdale’s surgery dressings were later found to be soaked with blood.
Mr Drysdale said in the moments after he learned of his wife’s death he called Dr Bright.”
For sure there there is no solid evidence that adipose derived SVF could have helped with patient’s dementia, I’ll give you that. In the article, there is no mention of how the cells were administered. However, this is no indication that adult stem cells are not safe if properly purified and administered. The problem is there are no standards on the processes used to extract, purify and insure viability of stem cells.
@WST & others,
Yes, could be the procedure. I can’t recall the # of times I’ve heard those doing stem cell treatments with adipose cells tell me that microlipo is basically “zero risk”.
Paul
Are they exhuming the body? The coroner must have quite a backlog since this happened in 2013 or is her husband suing the doctor? This story lacks detail which is needed to comment properly. It sounds like it may be a medical malpractice case to me. The liposuction procedure is invasive, especially if someone is elderly and frail.
I agree.