3 November 2015
Comments: Comments Off on Safety of Orthopedic Stem Cell Therapies
Category: Blog, Treatment Options
3 November 2015, Comments: Comments Off on Safety of Orthopedic Stem Cell Therapies

Looking for some information on the internet I stumbled into a page, put up by an organization called the International Society for Stem Cell Research, entitled: “Nine things to know about stem cell treatments.” The first statement on that list reads like an ominous warning: “Currently, very few stem cell treatments have been proven to be safe” and further down the list I found this other statement: “Cells from your own body are not automatically safe when used in treatments.” Those statements are highly misleading, and the first one is factually wrong, but, they raise an important question about the safety of stem cell treatments. A question I am being asked almost on a daily basis by patients who are looking for alternatives to the current orthopedic treatments, which are either ineffective, or that can have potential catastrophic side effects. For that reason I think it is imperative that we address those concerns about safety.

Stem cell therapies are relatively new, and, they are being offered as a treatment for an increasing variety of ailments ranging from autism, to Parkinson’s, to lung disease, to baldness, to erectile dysfunction. I will not try to explain the safety record of stem cell treatments for all conditions, but, will limit the discussion of this topic to what we do: applications of stem cell therapies for orthopedic disorders.

First, the use of stem cell treatments derived from the bone marrow is not new. It is called bone marrow transplant, and it has a long and excellent safety track record. The use of those bone marrow-derived stem cells for the treatment of musculoskeletal and orthopedic conditions is much newer, but it too, has already an excellent track record for safety. Several large case series have already been published, including thousands of patients, with minimal, or no serious side effects reported. Recently, a systematic review of the literature for intraarticular stem cell injections was published. This literature review included an analysis of 844 treatments with a mean follow up of almost 2 years. It found an extremely low incidence of reported adverse effects (only one infection) related to these procedures. The conclusions of the authors of this literature review concluded that the application of intraarticular injections with bone marrow derived stem cells appeared to be safe.

A common question from our patients is regarding the possibility of stem cell therapies promoting cancer. Some academics have warned that these problems could occur years after a stem cell treatment is done. Dr. Phillippe Hernigou from France, considered the pioneer in the use of stem cell therapies for orthopedic conditions, addressed this issue with this massive review of 1873 patients with a mean follow up of over 12 years. His groups found no increased cancer risk in patients after application of autologous stem cell therapy.

That second statement: “Cells from your own body are not automatically safe when used in treatments.” is technically correct, but misleading. This relates mostly to stem cells that are cultured and expanded in labs and then re-injected. I would be concerned about having stem cells that were grown and expanded in a lab overseas, where quality control is unknown, injected back into my body. Another concern is that the longer the stem cells are grown in the lab, the higher the probability of having cell mutations that could lead to unwanted side effects when those cells are re-injected. But, again, this applies to stem cells grown and expanded in a lab, something that you cannot do in the United States for clinical purposes (not research). All stem cell procedures done clinically in the United States require that stem cells are re-injected the same day they are harvested and with minimal manipulation. Under those conditions cell from your body are safe when used in treatments, as discussed previously. Stem cells injections are not 100% safe. No medical procedure is. But, they are not more dangerous (most probably less dangerous) than having foreign chemicals, like corticosteroids and hyaluronic acid, injected into our bodies.

This brings us to the next thing to consider related to the safety of stem cell procedures for orthopedic conditions: What are the alternatives for treatment? Are the other alternatives safe? As our population is getting older, more obese, and less active, we are seeing a tremendous increase in the prevalence of chronic musculoskeletal pain. Low back pain is one of the most common reasons for American patients to visit a doctor. Joint pain is not far behind. More and more patients want an answer for their chronic pain complaints, and that answer used to be an almost indiscriminate use of non-steroidal anti-inflammatory medications. As discussed in a previous blog, the use of this medications is associated with significant risks. These medications, which are now available over the counter, used to kill more Americans than any other class of medications. Use of NSAID’s results in over 14,000 deaths, and 100,000 hospitalizations each year. And that is just in the USA. Since the mid-1990’s, when doctors became more liberal in prescribing opioid medications for non-malignant chronic pain, the number of deaths related to use of opioids have been steadily increasing, and now opioids are the most common cause of drug related deaths in the USA, at over 16,000/year. Even the use of the relatively innocuous Acetaminophen results in over 1,000 deaths/year in the USA.

The other common alternative for the treatment of chronic back and joint pain is surgery. This alternative is becoming more and more prevalent as the rate of joint and spine elective surgeries has skyrocketed in the USA during the past decade. Surgeries are associated with significant morbidity and mortality. The most common complications of these surgeries are infections, bleeding, and blood clots. But, joint surgeries have also been associated with increased incidences of strokes and heart attacks. Spine surgeries can lead to nerve damage, bowel and/or bowel incontinence, paralysis, or even death.

In summary: as we are entering the age of biologics and regenerative therapies in the field of orthopedic medicine, the safety of autologous (from your own body) stem cells for orthopedic applications has been established, and continues to be established in the medical literature. Reports that stem cell therapies are potentially dangerous are outdated and do not reflect the best evidence available at this moment. Reported adverse effects related to stem cell therapies for orthopedic disorders are extremely rare and minor. There are no immune rejection issues, no communicable disease issues, and no carcinogenic issues. Stem cell injections are certainly safer than the current alternative treatments, including medications associated with the death of more than 30,000 Americans per year, and surgeries which carry significant risks of serious complications.


To learn more about non-surgical alternatives to joint replacement or spine surgeries go to: www.dontoperate.com .