Stem Cell Experts Launch Site Warning Against Unregulated Clinics (video)

The ISSCR is trying to keep patients away from unregulated stem cell therapies.

The International Society for Stem Cell Research (ISSCR) is looking to grab the reins of the conversation about controversial stem cell clinics. They have just launched “A Closer Look At Stem Cell Treatments” a website that offers to inform potential patients about the known scientific facts surrounding stem cell therapies being offered today. Formed from leading scientists around the world, the ISSCR urges individuals to talk with trusted medical professionals before undergoing treatments which they paint as unregulated, unproven, and perhaps unsafe. While the site is framed as informing the public, the online statements from prominent members (see the videos below) leave little doubt that the ISSCR is actually trying to persuade the public to have patience and wait for stem cell treatments to make their way through established regulatory channels like the US FDA or the European EMA. I agree with the sentiment, but I doubt it will work.

As I discussed earlier, stem cell therapies are becoming a larger draw for the medical tourism industry, a field which handles millions of patients and generates billions of dollars in revenue each year. Many of the clinics which will provide stem cell treatments are located outside the heavy (and slow moving) regulation of the US and Europe, though a few (such as XCell in Germany and Regenexx in Colorado) operate within them. Essentially this means that most stem cell therapies a patient could receive have not undergone the rigorous peer-review and clinical trial process that characterizes western medical practice. That’s something that Irving Weissman, Sean Morrison, George Daley, and Elena Cattaneo of the ISSCR are clearly uncomfortable with:

[Each of the following videos covers similar topics. Feel free to skip around or jump ahead once you get the drift.]

[More ISSCR videos can be found on their YouTube channel]

These testimonials from prominent stem cell researchers are just one aspect of the ISSCR’s new site. “A Closer Look at Stem Cell Treatments” also provides readers with a list of helpful questions to ask their prospective stem cell providers, explanations of the scientific/clinical trial process, and information about stem cells in general.

The ISSCR plans on reviewing those clinics around the world which offer stem cell therapies to their patients. Their review process will be dependent on visitors to “A Closer Look…” You may submit the name of a clinic for review via an online form. ISSCR officials will then contact that clinic, asking them to provide information on the efficacy of their treatments, the ethical overview they used for protection of their patients, and what (if any) regulatory approval they’ve earned. Eventually this information will be posted on the site as a guide to the clinics, but the ISSCR says there is likely to be a four to five month turn around between submission and results (to allow clinics the time to respond).

It’s unclear how useful this information will be to those interested in pursuing stem cell therapies. As stated in their disclaimer page, the ISSCR will not be endorsing or condemning any clinic, only reporting on their response to the ISSCR inquiry. There will be no inspections or visits to the clinic, the ISSCR will be completely dependent on the information each facility provides (including any associated peer-reviewed publications).

Essentially then, I can only see “A Closer Look…” as fulfilling one purpose: to stop US and European patients from pursuing unregulated stem cell therapies abroad. I think that purpose is clear from the general structure of the site, the attitudes in the expert videos, and the previous recommendations of the ISSCR. Looking at the disclaimer, the site will not be reviewing clinics using “bone marrow… to treat damaged blood forming or immune systems” – in other words, the bone marrow transplants used to treat cancers and other diseases for decades. Clearly the site is aimed squarely at the newest and most controversial stem cell therapies.

I totally understand the ISSCR’s point of view. As amazing as the anecdotal evidence is for many of these clinics, the vast majority simply do not have the rigorous scientific data to back up their claims. That means the risks associated with these treatments are largely unknown. Patients could be paying tens of thousands of dollars for therapies which may not only fail, but also harm them irrevocably. The ISSCR is trying to keep patients safe by keeping them away from therapies they see as untested and unproven. Again, totally reasonable. And, as we’ve seen with recent closings in Costa Rica, ISSCR isn’t the only group interested in tightening the noose on unregulated stem cell clinics.

But I don’t think it will work. People willing to travel thousands of miles to get an experimental treatment are not your average patient. These are individuals that have suffered (are continuing to suffer) from debilitating conditions and that often have tried almost all other possible solutions to their problems. They are willing to wager their funds and their lives based on anecdotal evidence. Urging them to be cautious and patient is simply not going to work. Most are literally sick and tired from waiting for well-regulated medicine. Some simply do not have any more time to wait. As long as there are patients willing to travel, there will be clinics waiting for their arrival. The recently closed clinic in Costa Rica more or less moved to Panama.

And I must admit, that one or two (really no more than that) of these ‘unproven’ stem clinics seem legitimate to me. I have pointed a few friends to orthopedic stem cell treatments because a) they have a successful history of use in large animals and b) the people pursuing them are doing so with scientific rigor. I would be very cautious before subjecting myself or anyone I love to these therapies, but I can’t rule out the possibility of their use altogether.

For better or for worse, stem cell based medical tourism is going to continue. I applaud the ISSCR for trying to inject some scientific perspective and sanity into the discussion, but I will be surprised if “A Closer Look…” dramatically affects stem cell clinics around the world.

You have two competing forces at work here, the voice of scientific caution, and unbridled hope in miracle cures. The winner is clear. ISSCR isn’t alone in urging the public to have patience with the emergence of regulated stem cell therapies, but they are outmatched by the hope in the potential for these technologies. People want these treatments now.

The irony is that the day is quickly coming when proven stem cell therapies will be available. Clinical trials for stem cell therapies are underway and progressing quickly. It may only be a few years before some of these treatments are actually available to the public. Until that time arrives, I think the efforts by the ISSCR serve a valuable purpose. It’s an uncertain time for stem cells, and anyone who is trying to help clarify the situation is doing a service, even if they are heavy-handed. They may not stop people from trying experimental procedures, but may they help them do so cautiously and while avoiding the outright frauds in the field.

Man, I can’t wait for a time, maybe in the next decade or so, when all of this worry and controversy has faded away….It will go away, won’t it?

[image credit: ISSCR]

[source: ISSCR