Seven years ago Dr. David Crane, of Crane Clinic Sports Medicine and Dr. Michael Scarpone, currently the team physician for the Pittsburgh Pirates, started looking at some of the information coming out of Germany in regards to biologics. After doing so, he started using Platelet-rich plasma therapies in his practice.
Now, Dr. Crane has seen 10,000 plus patients, treated 7,500 patients with PRP and many of his patients have been professional and collegiate athletes.
“I tell people basically we are working on the linkages — the connections between tendon and bone, tendon and muscle,” said Dr. Crane. “That’s usually where things tear and have chronic breakdown between tendon and bone and tendon and muscle, or between the meniscus and the bone or the fibers.”
Dr. Crane says sometimes a tear occurs in the middle of the tendon but usually he see’s it where the tendon meets another structure. “Or, they fall apart, they get disease or tendinopathy. Tendinopathy has been the bane of everyone’s existence for over 50 years. There was never a good answer.”
When the PRP procedure started, the FDA approved a table-top machine for the procedure. “You could spin whole cells and you just took peripheral blood and when you spin it down you obtained a platelet concentrate,” Dr. Crane said.
The concentrate has many growth factors and some other adhesion molecules. This was then put on the diseased structure, the tendon or ligament.
“Then the FDA got involved and started putting some handcuffs on some of the technologies you can do in the clinics,” said Dr. Crane. The two terms which are used to define the different practices by the FDA are “minimally manipulated” and “more than minimally manipulated” cell rules. In PRP the cells can’t be culture expanded to get a high number of cells and you can’t put anything in the cells, like human growth hormone.
Dr. Crane has seen success in the procedure with about seventy-five percent to eighty percent of the patients with tendon and muscle injuries having significant improvement. He believes in using guidance for every procedure he handles.
“Instead of going into the clinic and having someone blindly put a needle into, say, your ankle, one of my things is treating regionally not locally,” Dr. Crane said. This means the entire joint structure has to be treated along with making sure the tissue is placed exactly where it is supposed to go. “I care about deploying the grafts right where the tendon or tissue is falling apart, which is generally at the linkage point. Unless you have some way to look under the skin, using something like an ultrasound machine, and actually looking at the tissue itself I don’t think you can find those points very accurately.”
Why did Alex Rodriguez go to Germany for the Orthokine therapy?
Both Dr. Crane and Dr. Cardone agree the United States FDA is more conservative. Often procedures are approved outside the US before they are approved here.
“The procedure Rodriguez had done — what we know about it– it’s called the Orthokine and it’s kind of very similar to PRP,” Dr. Cardone explained. “What this doctor in Germany, what he says that he is doing, is activating this other protein. So, when we talked about growth factors in PRP they are really proteins, so [this doctor] is saying, that he is activating a specific protein of this interleukin-1.”
According to Dr. Cardone, Interleukin -1 is like “an antagonist” to the inflammatory protein. When interleukin-1 is around, whether it is related to injury of the joint, tendon or even arthritis, it can lead to more inflammation and pain.
“So what he’s done in his PRP, assuming this is what he’s done, he’s gotten some activator for this Interleukin – 1 antagonist, to fight or shut off the Interleukin-1. So that it’s no longer pro-inflammatory,” said Dr. Cardone. “It’s almost like taking Advil, Motrin, or Aleve by mouth but now you’re injecting it into that specific area. … So potentially you are injecting this anti-inflammatory into the area and decreasing inflammation, which is part of what PRP is about.”
This other type of PRP, which Rodriguez had injected, Dr. Cardone believes may not have any better healing properties versus any of the pathologic changes but it may offer some anti-inflammatory response. In other words, Rodriguez’s joint may feel better but it does not necessarily mean it is any healthier long term.
The question then becomes, is this procedure (as Dr. Cardone described it) outside the lines of minimally manipulated cells?
“This is something that there is no reason why it couldn’t be done here,” Dr. Cardone said. “This is just a PRP, but potentially it’s like turning on a different protein.”
Dr. Crane agrees: “There’s no reason he couldn’t get this therapy done in the Unites States.”
What is MLB’s stance on Platelet-rich plasma therapies?
The Commissioner’s Office of Major League Baseball acknowledges PRP as an evolving therapy and one where the indications are still being developed.
“MLB is aware of these therapies,” MLB spokesman Pat Courtney said. “It is the decision of MLB Clubs, based on the advice of their medical staff, whether to allow players to undergo platelet-rich plasma therapy as treatment for an injury. Like any treatment, the views of the medical community are varied on the efficacy of any treatment. The Commissioner’s Office does not regulate player’s medical treatment unless such treatment violates our drug programs.”
Platelet-rich plasma therapies are not banned under MLB’s drug program unless the player receives a Prohibited Substance, like HGH, in connection with the treatment.
“The Commissioner’s Office has no official position on platelet-rich plasma therapy from a medical perspective,” Courtney said.
The success of any athlete is attributed to their ability to execute perfect muscle memory. While baseball players are not necessarily more susceptible to micro-trauma injuries than other professional sports there may be more of a need in baseball to find a way to stop the body from breaking down due to the amount of games played and the very limited rest and recovery time during the season.
“They are always going to look for that magic pill to prolong their career,” Dr. Cardone said. “Who knows what it’s going to be; synthetic medication, synthetic injection or this blood craze will turn out to be something. Maybe it’s true, maybe we are on the right track and we just need to turn on the right healing factor.”
The complications with PRP therapy
One of the difficulties in evaluating PRP therapy is defining exactly what has been done by each doctor performing the procedure. There are many different types and forms of PRP and one doctor does not necessarily know what procedure the other is using.
“Classically, for 50 years we’ve had steroids and all you had to do is draw it up,” Dr. Crane explained. “It didn’t matter if you shook it, or you did something to it. You could stick it in the joint and it obviously blocked the body’s response to pain and inflammation, but it also blocked the body’s response to healing. So steroids were a double edge sword: it helped block your body’s pain response for generally three months, the problem was it hastened joint degeneration or tissue degeneration.
“The nice thing about biologics is as far as we know, based on the seven years we’ve experienced, they don’t lead to further degeneration. They actually block the degenerative potential of the steroids even if you use them with steroids.”
Dr. Cardone and Dr. Crane both agree the PRP is a very safe procedure but they disagree on the results they are seeing. The biggest complaint Dr. Crane receives about PRP is patients experience some pain for anywhere between three days to a week after the procedure.
“The biggest issue right now is that people want to find the magic bullet,” Dr. Crane said. “You can’t put a patent on your own cells, so if you want to develop something that is going to be the next blockbuster drug you have to find the molecule that is going to do magic and then you patent it.”
Dr. Crane believes this is causing little disclosure by the doctors in regards to exactly what process they are using and a broad stoke nomenclature to describe the PRP methods.
With the procedure Dr. Cranes uses his clients have seen great success with PRP. According to Dr. Crane, a key element for successful PRP is not to take the body’s system apart. “Once you do that the whole thing falls apart,” he said. “The body works as an orchestra — not as a solo — for the whole entire regeneration potential.”
Both Dr. Cardone and Dr. Crane would like to see more studies with a large group of patients and have a placebo injection put up against PRP. “Most of the studies have been very limited against the placebo,” said Dr. Cardone. “Or, even just using a dry needle and poking the tendon in and out with a dry needle.”
According to Dr. Crane the difficulty in procuring more studies on PRP is finding the funding to do so and finding a good placebo.
There are many challenges to finding a safe, legal, and effective procedure for expediting the healing process of the body.
The fact remains athletes will continue to push the threshold of what the human body is capable of doing, and as a result they will need to unlock the door to rapid healing. The question remains: will they need to go to Germany to do this?
“I hear about the guys going over to Europe for specific treatments and the question is: did they have to go to Europe for a specific treatment?” Dr. Crane said. “Ninety percent of the time the answer is no.”
Editors note: post updated 11:00AM December 31, 2011
Anna McDonald contributes to ESPN’s Page 2 and her ESPN archive can be found here. You can follow her on Twitter: Anna__McDonald.