Recently we blogged about the proliferation of clinics offering an expensive, unproven stem cell treatment for arthritic and damaged knees.
In the current edition of the Clinical Journal of Sport Medicine, the Australasian College of Sports Physicians (ACSP) published a position paper on the use of mesenchymal stem cell therapies in sports and exercise medicine. You can find the full paper here. It’s well worth reading if you are thinking about spending thousands of dollars for such a treatment or know someone who is.
Mesenchymal stem cells are commonly extracted from adipose (fat) tissue, skeletal muscle, umbilical cord blood, placenta, and bone marrow. In our blog post we dealt mainly with a same-day treatment known as the BMAC (bone marrow aspirate concentrate) procedure. It involves extracting the mesenchymal stem cells from a patient’s pelvis, running them through a centrifuge to concentrate them, and then re-injecting them into the bad knee to reduce inflammation and repair damage. The ACSP, which represents sports physicians in Australia and New Zealand, also considered a treatment in which cells are extracted via liposuction from fat tissue and then put through the centrifuge — a procedure the U.S. Food and Drug Administration is cracking down on.
The paper suggests technology is running ahead of scientific knowledge: “A contemporary development in manufacturing techniques uses far shorter preparation times (often less than two hours) at far less cost, producing a non-expanded mixed cell population. However, mesenchymal stem cell numbers are low in these preparations and the presence of multiple cell types raises questions about the efficacy of these techniques. Although the progress in biotechnology has resulted in commercially attractive outcomes, the science substantiating their effectiveness has lagged behind … No published randomized controlled trials for ‘same-day bone marrow stem cell concentrates’ are available as of 2015.”
This is not to say such treatments don’t work, but that much more study is needed. And it needs to meet the gold standard of a double-blind, randomized, placebo-controlled clinical trial in which some patients get the mesenchymal stem cells and others get a placebo treatment. The ACSP found only one such trial has been done and it did not involve BMAC. Rather, it demonstrated no difference in outcomes between the treatment group who received adipose-derived mesenchymal stem cells and those who got a saline injection. The full study has yet to be published.
According to the ACSP, using stem cells to treat damaged knees should be initiated under only two conditions:
- As part of a rigorous clinical research trial.
- As an individualized innovative therapy where there is a commitment to the transparent collection of data for analysis by a research body external to the clinic.
“Innovative therapy” refers to a treatment undertaken by a physician in the hope it will help the patient, though its effectiveness has yet to be proven. The upside is that this is how medical practice improves: doctors try something and it works. The downside, as the ACSP notes, is that such treatments may become adopted practices with no proof they actually do any good. The worst case scenario is that an unproven treatment actually does harm.
Randomized, placebo-controlled clinical trials can take years and cost hundreds of thousands of dollars. To someone with arthritic or damaged knees — or hips or shoulders for that matter — it’s cold comfort to hear that more study is needed before such stem cell treatments get the thumbs up or thumbs down. In the meantime, we don’t know.