Stem cell clinic firm US Stem Cell has just had a major paper retracted. Two of the notable authors on that paper are US Stem Cell leader Kristin Comella and stem cell researcher Thomas Ichim, who was senior author. It’s not clear to me if Comella currently has a role in the firm or not.
Retraction Watch first posted about the retraction so a hat tip to them. You can also read the actual retraction notice for the stem cell paper from the Journal of Translational Medicine.
The retracted paper’s title was, “Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis.”
A reader on Retraction Watch pointed out that Ichim has had another retraction of a stem cell paper from the same journal.
Stem cell clinics & their data
Over the 11+ years I’ve been writing here on The Niche there have been times when I challenged unproven stem cell clinics to show their data if they had any. Sometimes they would present data that seemed pretty iffy. I even saw in some cases their best ‘data’ seemed to be hand scrawled on scratch paper.
In rare cases they could point to published papers, which should in theory be a lot better. But I’d never heard of some of the journals publishing results from stem cell clinics. I also couldn’t tell if they did a normal peer review. What would keep the quality of papers high at such journals?
US Stem Cell was one of the few clinics that published data.
US Stem Cell Retraction
In this new retraction, the issue at hand seemed to be related to the research and ethics approval timing.
From the Editor-In-Chief of the Journal of Translation Medicine in the retraction notice:
“The Editor-in-Chief has retracted this article [1] due to a number of concerns that have come to light after publication. The clinical trial registry [2] for this study states that the study start date is 12 February 2012. However, documentation regarding the ethical approval provided by the corresponding author shows that the authors applied for ethics approval on 18 February 2012, and that the ethics committee approved the study on 17 September 2012. Additionally, the time stamp on Fig. 4a is 11 September 2012 and on Fig. 4b it’s 27 February 2010, which suggests the research was conducted before ethics approval was obtained. The Editor-in-Chief therefore no longer has confidence in the reliability of the data reported in the article.”
This particular paper was important for stem cell clinics. It argued that the use of fat stem cells (aka adipose stem cells or stromal vascular fraction (SVF)) in this kind of situation was safe and probably helpful for arthritis. Most other clinics selling similar offerings never published data.
Looking ahead
This retraction just adds further doubt for many of us about the use of SVF for arthritis.
In terms of the future for US Stem Cell as a business, we are awaiting the outcome of their appeal of their loss in federal district court.
To the best of my knowledge this clinic firm still has an injunction against it, which prevents it from injecting SVF into patients. I’m very curious to see how the appeal goes.
Um, no you didn’t.
Steven
This piece highlights a retracted article. Paul did not retract this, the journal editors and publisher did. So, Paul is not policing anyone, just highlighting the continued challenges in this field.
I think what Paul and I endorse are high-quality randomized trials to support claims that different cell-based therapies are actually effective for patients. To my knowledge, there is little such evidence like this to demonstrate efficacy of SVF and similar cellular agents. Indeed, probably the only quality randomized trial from Mayo clinic demonstrated saline injected knees improved patient symptoms the same as cell-injected knees. So, no benefit to cell-based therapies.
Anecdotal evidence does no good to support claims of benefits from cell-based therapies for joint pain and such. Unless practitioners in this field decide it is finally time to do quality trials, there is no way this area will advance in meaningful way.
Paul. This study is about a decade old. Is digging up something like this really valuable? While you’ve positioned yourself as the police force unelected for the stem cell industry privileging the work of your friends and condemning others, this seems almost desperate. Remember that for many years, you only would support embryonic and fetal research. Do you still think those are the only good sources of stem cells? Data changes with new discoveries and being open-minded makes us more agile and improves the field much quicker. That in turn can bring real relief to many who suffer and would benefit with stem cell treatment. Many forward thinkers see the broken Three Phase Clinical Trial model is broken: Do you really have to ignore efficacy results from Phase 1 when doing Phase 11? Are there smarter and more efficacious ways of going about clinical research than a many decades old model that was created before the internet and cloud computing? Antiquated and arrogant thinking inhibits innovation.
I had 10 million embryonic stem cells injected into my knees in March 2019. Positive results lasted into mid May of 2019. I got a certificate with my injections of authenticity. I would do it again but too costly most places.