How seriously do patients consider stem cell clinical trials?
This is the first in a new series of posts I’m doing in lessons I’ve learned from the ever-increasing number of patients who contact me directly or are readers of this blog who make great comments.
Today’s post is focused on the lack of availability of and exclusions of the vast majority of patients from clinical trials, an issue that I believe many stem cell researchers are largely unaware of at this time.
The standard advice in the stem cell field is to encourage patients to avoid unlicensed stem cell treatments like the plague and opt instead, if possible, for stem cell clinical trials.
An important question remains: just how realistic are the chances for most patients to get into clinical trials?
The answer is that the average patient has at best low odds of getting into a relevant clinical trial for their disease in general and almost zero chance for many individual diseases.
To be clear, I’m not saying I advocate unlicensed stem cell treatments. I don’t. In fact, I advocate against them because I have not seen evidence they are safe and effective.
However, at the same time, we in the stem cell field need to talk more with patients about the realities they face including (A the rarity of and (B) exclusion of most patients from clinical trials.
One can be excluded from clinical trials for countless reasons ranging from one’s age to one’s other conditions to the way the disease in questions manifests in you.
For example, many patients with various diseases contact me and tell me they have tried unsuccessfully to become participants in clinical trials.
Again I’m not saying this makes it logical to get an unlicensed, non-FDA approved stem cell treatment. I think that in fact such treatments have little chance of benefiting patients and many risks. It is somewhat understandable that the designers of clinical trials want to focus on very narrow populations of patients to limit variability in the outcomes.
But we in the stem cell field need to be aware of realities faced by patients. It is so important for all us in the stem cell field to understand as best as possible the obstacles that patients face.
Patients have a lot to teach us just as we can teach them. One lesson from them for me and probably for you too if you are a scientist is that one, as a patient, cannot simply decide to join a clinical trial for one’s particular disease. Trials may not exist and if they do, few patients can join them.
I was diagnosed in 2010 with moderate emphysema. I’ve been on advair and albuterol which is effective up to a certain point. Signed up for a clinical trial and was accepted by that was for a drug study, and by the time they were ready to begin, I was already aware of, and doing research on stem cell therapy, and declined to participate. I would be interested in participating in a stem cell therapeutic study targeted for emphysema if I could find one.
*but that was
Paul, this is an important post on your part. Most will agree with you that CTs are not a very good access point for pts in need. Your point begs for innovation in a new model of stem cell research. The real world of patients is not exclusive of complications. CTs are probably one of the few places where disease processes are narrowly focused. And I understand the reasoning, but patients receiving FDA approved treatments are likely to have other problems. And so it could be argued that CTs should have fewer exclusions so as to reflect scenarios in patient care. I know this makes for difficult CTs, but it would be more representative of the general pt population where these treatments have to work. Thanks again for this good post.
I have put together a table of the known stem cells in ophthalmology clinical trials, including live links to the specific trials. Many are recruiting, so if you fit the criteria (and live close to where the trials are taking place) you might be eligible.
The table includes a list of the fourteen ophthalmic applications and the thirty-four clinical trials completed and underway. To take a look, follow this link: http://tinyurl.com/StemCellClncal
Irv Arons