March 22 Ft. Worth TX

March 28 Syracuse NY

Please contact your Zimmer representattive to attend.

One of the ongoing issues has been the dose. Like any drug, it sure helps if the doctor knows the right amount to give. Older technologies that simply use a centrifuge to prepare PRP have no indication of (a) the patient’s present platelet count and (b) the amount of concentrate produced. If you know both numbers, it is possible to calculate the amount of “growth factors’ that are being introduced. It is only by these type of measurements that we can advance the field and produce improved results for our patients.

The cell counter picture here solves these problems. A small portion of the patient’s blood is pre-tested to determine platelet count and white blood cell count. After concentration, the test is repeated with a tiny sample from the PRP concentrate.  By comparing these values, we can (1) know what we are administering and (2) adjust the Angel machine sensors to either increase or decrease the white cell population.

The last comment is very important as we get to “stem cell” purification.  The advantage of advanced analytics is that we can select out the correct cell population, for example from bone marrow, and establish a reproducible “dose” for the patient. This after all is the essence of quality assurance- verification.

The hype of new kinds of cell therapy will only be realized when the science catches up with the potential…

For example, I saw on 60 minutes Jan 8.2012 yet another medical scam based upon stem cells. Desperate diseases demand desperate measures, I know, but that does not prevent quacks from taking people’s money, and to no avail for the patient. If patients are to inform their choice by using the internet, they had better do their own diligence- a very similar concept to a financial transaction.  Caveat Emptor.

Look for the following: publications in a well respected journal,  presentations at national meetings, animal models with favorable results, clinical trials sanctioned by the FDA; these will at least tell you that the concept is taken seriously.  And always remember the words of Judge Judy, “if it doesn’t sound right, it isn’t true”.

The use of PRP for “regenerative” purposes has been well documented elsewhere for as diverse purposes as cosmesis, hair growth, tendinopathy, heart disease and many other health problems. Scientific evidence in well controlled studies for improved outcomes has yet to be produced for most of these issues. One area in which we will soon seen some early outcome studies is the use of PRP for osteoarthritis, an indication that I have been exploring for about two years.

When investigating a disease as manifold as osteoarthritis (OA), it is important to set the ground rules appropriately. First, the patients need to have IMO mild or moderate disease, not the end stage bone-on bone disease with associated abnormalities- like crookedness and looseness- that cannot reasonably be expected to be helped by injections. If you include these severe cases in a sample, it is a guarantee the results will not be comforting. The film on the right is still acceptable for PRP treatment.

Second, one has to spend time on investigating the precise PRP that is being used- how concentrated is the product- and this varies widely depending upon the manufacturer. To some extent, it may also vary according to the patient’s native platelet count- more on this later. Once we know the dose per injection, then we have to determine the right dosing schedule- how many injections?  In other words, if PRP is to be accepted in the long term, we need to establish a dose-response relationship, as with pharmaceuticals.

Finally, it would helpful to compare PRP with other available injectables. Even though commonly used, I will rule out cortisone as a comparator because of the obvious side effect upon cartilage. Patient’s experience excellent short term results with cortisone injection, but I have seen some of the worst cartilage damage in those joints subject to repeat injections.  I seldom recommend cortisone for that reason.

A reasonable comparator would be hyaluronic acid (HA), now available under many brand names for injection (and also used for cosmetic injections, and for eye surgery).  I have about 10 years experience with HA, and it is effective in pain relief for OA in about 2/3 of patients who try it. The effect can be months or even longer. HA is composed of large, viscous molecules and does not contain growth factors.

A study comparing HA to PRP for OA of the knee is being performed at Rush Medical  at the present time, and we eagerly await the results. Early indications appear favorable for PRP, but this study has not yet been published in a reviewed journal. A similar study performed in Italy has shown excellent medium term results with PRP.

In my opinion, high concentrates (12-14x) of PRP are effective for pain relief due to OA if given to appropriately selected patients. The regimen requires (2) injections over a 2-3 week period. The response rate is approximately 85%, a definite improvement over HA.  The duration of symptom relief is variable, but appears to be in the 6-12 month range.

I look forward to learning more about PRP in 2012 as new studies become available and better analytics allow us to better quantify precisely the dose we are administering.

Call it a Holiday story, because at the time of this writing you see her here hiking in Israel, pain free.

She came to me about 6 months ago with chronic symptoms of pain that defied all sorts of treatment, including prodigious exercise therapy and nutritional supplements. She is fit and enjoys working out.

The MRI revealed a full thickness loss of cartilage about the size of a quarter

located on the condyle of the femur,  directly on a weight bearing surface. Once the location was confirmed by arthroscopy, a Denovo NT repair was carried out through a small incision. This was performed as an outpatient, and since the patient was visiting from another country she stayed in a local hotel for a few days and then convalesced with family in another state. After a couple of weeks she then flew to her home country and carried out her rehab there. We communicated frequently by email, and the therapist was great at that as well.

In the photo the patient is hiking up a steep hill, pain free.

This result is fairly typical for patients with isolated cartilage lesions. Note how this patient is an excellent rehab candidate, highly motivated, slim in stature and- as with all my Denovo NT candidates- has no arthritis in her knee.

Happy Holidays!

Currently, new medical devices or pharmaceuticals or put through extensive, costly, and often large “comparative” trials in which one group of patients is treated with an old method; the purpose is to both assess safety and efficacy of the new method/drug as compared to the old.

This procedure is already inappropriate for many “orphan” diseases, or situations in which no comparator exists.

In the future, as specific diseases are matched to the patient’s genome- and we find, for example, that cancers are really different in differing patients – establishing such large groups as we have done in the past may no longer be possible.  In effect, each patient may become his/her own control.

Please read the entire thread in SCIENCE if you are interested in differing opinions on this topic.

Click here for Dr. Marcus’ letter.

Chondrofix Implanted In Medial Condyle

The implant appears flush with the bone, the matrix layer intact with slight signs of wear. There is no discoloration of the surrounding tissues, and no loose fragments. We will continue to assess durability of these implants over time. At present, I am considering the use of Chondrofix for accessible lesions

in patients who cannot or will not adhere to using crutches for 4 weeks post-op ( see Denovo NT).

Another potential indication for Chondrofix could be those cases of partial knee replacement where a “satellite” lesion is encountered next to the implant. Chondrofix has a shelf life of 24 months and for the latter situation it could therefore be available off the shelf- rather than pre-ordered, which is the case for Denovo NT.