This week I saw yet another crazy press release. I usually see these from some university claiming a stem cell first that isnt close to a first. Yet now they also seem to be coming from doctors who are claiming firsts that are no where near firsts. This one was from an Orthopedic Sports doctor who claims to be the only orthopedic surgeon in the country using stem cells (we have a few in our network and bone marrow stem cells have been in common use by surgeons for at least a decade). The story was so riddled with inaccuracies (stem cells coming from blood, stem cells not being common practice because of the Bush Embryonic stem cell ban, that there is something unique about a little bedside centrifuge processing bone marrow), that I thought it was time to again differentiate what we do from the wild west of stem cell clinics cropping up.

When we first pioneered orthopedic stem cell therapy in 2005, we were the only physicians in the U.S. doing this type of work. This last few years has seen a bevy of clinics opening up and offering stem cell therapies for pretty much whatever ails you-from arthritis to ALS to COPD to MS. A few of these clinics are legitimately trying to do a good job, but most are not. How can you tell the difference? First, lets look at the clinic types that are popping up:

The Miracle Fat Stem Cell Clinic-These clinics offer treatments for a multitude of diseases that include knee and hip arthritis. They perform a small liposuction to get cells and as such, are usually run by a plastic surgeon who oversees a processing facility that distributes cells to other medical specialists. Some claim to be operating research studies, but when I have investigated these further, most of this is more sales than reality (i.e. one clinic system claimed to have a research IRB approval that turned out to have been rescinded). In addition, on the orthopedics side of the treatments, these are usually blind non-specific injections (without any guidance to ensure accurate placement) somewhere in the vicinity of the painful joint. They frequently will combine these local injections with an IV infusion of fat stem cells, 97% of which will end up in the lungs and never see the joint. As you know from previous blogs, fat stem cells dont work as well as marrow cells for orthopedic purposes, so the orthopedic side of the business seems to be an afterthought to drive revenue.

The Little Bedside Machine Clinic-These clinics are often more focused on orthopedic problems, but use an automated bedside one size fits all machine to process bone marrow cells and platelet rich plasma. Some of these clinics do offer guidance of the injection, but very little effort is placed on tracking patients or reporting outcome data. So the type of treatment registry data that youve read about on this site over the past month isnt going to be reported by these clinics, leaving the patient to fly blind on how well these procedures work or dont work. These machines also produce about 1/10-1/15th of the stem cells per unit volume as a Regenexx-SD procedure (based on our lab studies). They also only isolate one fraction in the bone marrow that contains stem cells and discard the other fraction (not knowing that it has valuable cells).

So what key components should a clinic have so you can feel comfortable?

Treatment Registry Tracking of Patients

Any new therapy that is yet standard of care needs to have data collected, even if it looks very promising from the standpoint of patient experience (i.e. a doctor says it has worked well in other patients). This means that standardized questionnaires are sent to the patient at set time points to see if they have less pain, more function, or had any complications with the procedure. This is a huge commitment on the part of the clinic and the doctor. As an example, right now we have a Clinical Research organization quality customized software to assist us in collecting data on the patients weve treated. We have two full-time employees to collect data, several part time supervisors, and a full time bio statistician to analyze this data. When we want to report the data, we must enlist the help of expensive physicians to call patients who havent responded to their questionnaires as this helps to make sure we have enough data to report. While we have a bio statistician, we must then use more expensive doctor time to help him decide whats clinically meaningful to analyze.

How can you tell if a clinic is doing this? They will have data from their patients that they have collected and reported, usually on an annual basis. As an example, the clinic mentioned above with the little bedside centrifuge that claimed magic, had no data and just began doing this procedure, so you wouldnt expect there to be any. Why is it important to see that clinics data? A procedure like this may produce very different results in a different doctors hands. In addition, the clinic will be able to tell you exactly how it collects its data, who collects it, how often, etc For example, a proper treatment registry collects data at set time points like 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, etc If all you get is a call from a nurse like you would after any common surgery, then this isnt nearly enough.

Guidance of the Injection

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