A recent article in the Denver Post, on April 13, 2010 discussed stem cell therapy for arthritis. I have had a number of patients ask me about this therapy and I wanted to discuss my thoughts on this topic. Before my comments on this procedure I would like to give some general information about osteoarthritis, the FDA and evidence based medicine.

Osteoarthritis is a condition in which the joint surface (articular cartilage) deteriorates and is worn off the bone. The function of articular cartilage is to protect the underlying bone from increased forces. When the cartilage is damaged the underlying bone is subjected to increased loads and this causes pain.  (Articular cartilage and Injury)

Osteoarthritis has become much more prevalent in our society because our population is getting older. Physicians and patients are constantly looking for new solutions to this problem however, we need to be careful that these treatments are safe and effective. Many of the things that you read in the papers and on the Internet are incorrect. In a study a few years ago it was noted that 70% of the information on the Internet concerning medicine was incorrect.  I recommend that when you are evaluating medical conditions that you try and use reputable sources.  Links

The FDA (Food and Drug Administration) is an organization in the government whose mission is to evaluate medical treatments and therapies to make sure that they are safe and effective. In order for drugs, medical devices and implants to be approved in the United States there is a process that they need to go through.  In general the steps involved is that the drug or treatment is evaluated to determine that it is safe (that side effects are documented and known),  that a proper dose is known (dose response) and that it is effective as compared to a control or placebo. This is a very vigorous process and is done to protect us as patients and consumers so that we avoid the days of “snake oil salesmanship”.  In the past the process for approval was not as stringent and because of that there were some drugs and devices that were approved and in follow up were noted to have significant side effects.  Examples of this include some anti-inflammatory drugs (associated with heart attacks) and implants associated with early failure.  It is because of this as well as other problems the FDA has tightened up its process of approval.  It is done for our protection!

In orthopedics we have followed the lead of the FDA and are trying to develop treatments based on evidence.  In the past our treatments were based on our individual or our colleagues experience.  A treatment or a procedure was done and then we would see how that person or group of patients did.  We are now trying to evaluate treatments with studies that look at groups of patients and compare them to a control group (placebo) these types of studies are called prospective randomized.  These are the types of studies that give us as physicians the best evidence that a treatment is effective or not.  This is what we are now trying to base our treatment decisions on.

Concerning the stem-cell therapy for osteoarthritis, I would like to clarify what exactly stem cells are. In adults, stem cells are found in bone marrow.  These cell have the ability to transform and mature into other types of cells and can initiate repair and healing. The hypothesis of the physician in this article is that injecting a concentrated mixture of these cells into an arthritic joint can stimulate a repair process. The procedure involves aspirating blood and bone marrow from the pelvic bone, that mixture is then taken to a lab and the cells are then concentrated. The concentrated mixture is then injected into an arthritic joint to induce a repair response and re-grow cartilage.

Although the treatment the physician in this article has developed is interesting let’s look at the information more closely. The evidence he has to support the procedure is anecdotal and involves the testimony of patients (2 in this article) who have noted improvement. This type of information is the least powerful (scientific) to be able to draw any conclusions as to its effectiveness.  It is noted that from 2006 over 500 people have been treated, it would be beneficial to have some idea how they did however this information was not provided in the article.  I have evaluated additional information on their website and the only the efficacy information are patient testimonials. It is mentioned in the article that the physician did have a study published in a “peer-reviewed” journal, however, it only evaluated safety and not efficacy (does it work).  The study evaluated 227 patients and they noted 10 adverse events (4.4%) and in 45 patients using high-resolution MRIs there were no tumors formed.  The reason that this was evaluated was that although these stem cells are supposed to regenerate cartilage because they have the ability to turn into other types of cells they theoretically have the potential to cause unwanted growths (it is noted in the article that one patient developed cancer). There have been no prospective (looking forward) randomized controlled studies that have evaluated this therapy. These are the types of studies that the FDA requires to get a treatment or drug approved and these are the studies that we as physicians are using to help determine proper treatment guidelines.

In conclusion, this stem-cell therapy is an interesting approach to a very common problem and should require additional evaluation in a controlled prospective fashion to ultimately determine if it is beneficial and safe. In the field of orthopedics there are many centers in the United States and around the world that are evaluating biologic solutions for the treatment of this disorder and I would predict in the next 10 years new treatment options will be available.  The key is that these treatments need to be scientifically evaluated (treatments that are prospective and controlled, and overseen by a review board) and not done and reported in a non-scientific manner.  Treatments based on this non-scientific approach have a greater potential to be ineffective and cause harm.

If you would like to view a program that discusses the scientifically supported treatment options for osteoarthritis click on this link.