SCIENCE OF STEM CELLS
Stem Cell Safety
Is adult stem cell therapy safe?
>> DR. MARC PENN: As a clinician scientist who’s been involved in the stem cell space, adult stem cell space, for the last 20 years and has participated in dozens of clinical trials, there is clear evidence that adult stem cell therapy is safe when done by competent clinicians well trained in the techniques necessary to treat patients with stem cells.
The risk is associated really with the procedure of delivering the stem cells: catheterizing the heart, injecting a joint, things of that nature. But the adult stem cells themselves — there’s no evidence they add a significant hazard or risk on top of that procedure.
Is SVF safe?
>> DR. PENN: Stromal vascular fraction, like all other adult stem cells, is similarly associated with a good safety record. The risk to SVF is the liposuction, which is done hundreds of times a day, and that risk is ultimately associated with the wound that gets caused for the liposuction itself. Remember, lots of people have liposuction, not for stem cells, but for cosmetic reasons. So, liposuction is deemed a safe procedure, but that’s really the risk with SVF.
Why is it important that the treating physician is a specialist?
>> DR. PENN: Studies done by others have shown that in stem cell clinics in the United States that treat heart failure, over 90% of them have no cardiologist on staff. Over 50% of them treating orthopedic conditions have no orthopedic surgeon on staff. So, you need to have people who are expert at the organ or the body part present to be able to make sure not only are you treated safely, but are the stem cells effectively delivered to the organ that needs to be repaired.
As a practicing cardiologist, I can send my patients to a cardiac catheterization lab to get a stent for a blockage in their heart, but if I don’t have an expert interventional cardiologist delivering that stent, the stent’s not going to work on its own.
That’s true for stem cells as well, and patients are spending too much time thinking about ‘what stem cell type I want’ versus thinking about who’s going to treat me with those stem cells. Both are critical, but we certainly know for sure that you need an expert clinician.
How important is safety at Okyanos?
>> DR. PENN: At Okyanos, we take safety very seriously. The only complications we’ve seen in a minority of patients, less than 1%, has been associated with the liposuction itself and some infection or cellulitis around the liposuction site. We have a concierge physician who follows every patient for 30 days after treatment so that we’re able to assess the patient – not for benefit per se, because it’s early in their course – but really about the safety of the procedure. A group expert at taking care of patients who have been treated with stem cell therapy is available to every patient so that they can get treatment if they need it.