To Registry, or Not to Registry? That Is the Question…
On LinkedIn in the Biologic Orthopedic Society, we’ve been discussing whether providers offering stem cell therapy should be required or should require themselves to track every patient in a stem cell treatment registry. Given the explosion of physicians taking weekend stem cell courses and the investigational nature of these therapies, do providers have an ethical responsibility to make a good-faith effort to track every possible treated patient, or is this a waste of time and money?
What Is a Registry?
A registry is a mechanism whereby a single medical provider or a large group can track patients for complications and outcomes over time. Validated measurements are taken before a procedure and then sent to patients at set time points after the procedure. These days, usually an electronic system pings patients, and then a staff member follows up when they aren’t responding.
For example, for knee patients in the Regenexx Registry (now the Interventional Orthopedics Foundation Registry) the patient fills out an International Knee Documentation Committee Form (IKDC), a Lower Extremity Functional Scale (LEFS), a Numeric Pain Scale (NPS), and a subjective score of percentage improvement. Patients are also asked tickler questions about whether their procedure led to any complications or side effects. These are filled out before the procedure and then sent at one month, three months, six months, and annually. The patient is pinged twice by the electronic system, and then two phone calls are made and a letter sent via the mail. If the patient can’t be reached, that time point is dropped and he or she is picked up at the next one. If any complications are reported, these are adjudicated by the treating physician as to relatedness or severity.
Registries like this are used to track the success of orthopedic devices, in cancer care, and in many other areas of medicine. While registry data always suffers from patients who fail to respond, the large numbers of patients being tracked allows for segmenting data in ways that smaller randomized controlled trials can’t. Hence, registry data is often used to plan which therapies or treatment strategies might be best for further research.
What Isn’t a Registry?
Calling patients once or twice after their treatment isn’t a registry. Asking doctors to fill out a form about whether patients had any complications isn’t a registry. In essence, anything that doesn’t involve a prospective attempt to collect data in a large population at set time points isn’t a registry.
The Ethics of Investigational Care
As a concept, care that’s new and different that poses mostly quantifiable risks isn’t new in medicine. For example, if it weren’t for physicians trying novel ways to attempt to save wounded soldiers during the Korean and Vietnam Wars, we wouldn’t have modern emergency trauma care. When care meets this definition, it’s known as investigational.
Using stem cells in 2016 for things like wound care and orthopedic, neurologic, urologic, endocrine, ophthalmic, cardiac, vascular, or other chronic diseases represents investigational care. While in some areas the outcomes are somewhat defined and in others very ill defined and the risks mostly quantifiable, none of these types of care are standard or traditional.
When faced with investigational care, it’s every practitioner’s responsibility to contribute to quantifying outcomes and risks. This doesn’t mean that everyone needs to be a research scientist, nor does it mean that every practice has to employ a clinical research coordinator. However, one way for each practice to contribute is to join a registry.
How Would 100% Registry Participation Make This Field Better and Safer?
We have many big unknowns in stem cell medicine. Who is likely to respond, and who isn’t likely to respond? Who is at a higher risk for a complication? Are all stem cells equal? Will some cell types do a better job for certain diseases? What are the exact risks by procedure type? A stem cell treatment registry would begin to answer many of these unknowns.
Take for example the concept of candidacy grading. Right now, outside of our network, a physician using data to tell a patient that he or she is either a good or poor candidate for a stem cell procedure is rare. It seems like many clinics use the concept that if a patient has a disease and if the doctor has some sense that the treatment could help, the patient is a good candidate. However, given the expense and not fully quantifiable risk of these procedures, is that the most ethical stance? Isn’t it more ethical to have data that can be used to make these kinds of candidacy determinations?
In addition, it’s often said that patients need unfettered access to stem cell investigational care. I agree with that statement, but which world serves patients the best? The one where there is limited data and a Wild West mentality or the one where everyone is required to collect and report data so that patients can make informed decisions?
Are There Enough Funds for a Stem Cell Treatment Registry?
It’s often argued that physicians using stem cells don’t have the pharma or government backing needed to collect data. Our own experience would seem to be prima facie evidence that this position is not correct. We were easily able to self-fund a registry from 2005–2015 until it was turned over to a nonprofit to run. So the idea that funds are what’s holding back registry compliance doesn’t hold water.
The Registry Pledge
Recently on LinkedIn, I asked providers to take “The Registry Pledge.” Basically, the idea was that educators teaching weekend courses and the physicians taking these courses and already using stem cells would refuse to teach or treat additional patients until a good-faith effort was made to track every possible patient in a registry. In addition, all of that data would be made periodically available online for patients, physicians, academics, and regulators to review. It was a bold plan, but I was surprised by the number of physicians who thought that this was good idea. While there were notable holdouts who by their silence seemed to give the idea a big thumbs-down, it’s a nice start.
How Do We Do This?
The world’s oldest and largest orthopedic stem cell treatment registry is ours. It’s now run by a nonprofit and open for any provider to use who treats orthopedic patients with FDA-compliant stem cell therapies. So for physicians in that space, for very little expense, all treated patients can now be tracked.
Next, we have several large companies involved in giving weekend stem cell courses that are doing quite well financially given my review of their SEC 10-K statements. I would call on these organizations to fund their own registries or come together to fund one that can track patients in many different kinds of care. Some adipose stem cell groups have stated that they are collecting data, so if that’s true, they should make all of their data available annually on their websites. Finally, the medical-device companies selling bedside centrifuges should also kick in to an existing registry or start their own.
What Will Happen if We Don’t Do This?
Nature abhors a vacuum and so do regulators. Given that regulators have no practical way to quantify the risks and benefits that these therapies pose, they have begun to regulate with a heavy hand. While I’m no fan of this approach and recognize that there are multiple agendas in play, can we really take the high ground on this argument without at least registry data to provide a foundation for that lofty perch?
The upshot? We’re at a crossroads in investigational care with stem cells. We need to herd the cats and make sure that everyone gets on board with the idea that data must be collected on every patient willing to provide it. This is more than just completing a few small studies or having doctors fill out a sheet, trying to guess if patients have had complications; we require full-on prospective data collection that only a well-run stem cell treatment registry can supply!