We were happy to have our treatment results for moderate arthritis accepted for presentation at the annual meeting of the most prestigious international stem cell conference dealing with adipose (fat) tissue (the richest readily available source of stem cells). In our series over 90% of eligible patients were able to avoid joint replacement surgery for a period of two years after treatment. Many are still doing well at longer follow up. Degrees of improvement varied. Some patients were pain free, some had residual pain but at a low enough level to avoid joint replacement surgery. All patients had discontinuance of pain killing and anti-inflammatory drugs except occasional Tylenol.
The treatment takes place in the office with minimal discomfort such that only local anesthesia is used. No sedation is used or needed. There is significant knee soreness for 3 days beginning on the evening of the procedure. Patients avoid exercising the knee for 1 week, but then may participate in any activities that do not cause pain.
Happily, results have been long lived. Of the 27 successfully treated patients in the series only one patient had return of pain requiring knee replacement, and this was 4.5 years after treatment. We have been offering the treatment for five years. There were no serious adverse events of any kind in any patient. The treatment is not covered by medicare or any insurance plan, but the cost is substantially less than the cost of joint replacement surgery.
The treatment is “immunomodulatory”. There is no regrowth of cartilage but growth factors in the stem cells help heal the cartilage that remains, and anti-inflammatory cytokines quell inflammation and pain. Even arthritic joints can heal to a degree and that is the purpose of the treatment. Joint replacement has a significant failure rate, and complications, such as infection, occur in some patients. It is also irrevocable, i.e. once the joint is replaced no other treatments are generally effective if it fails except re-replacement. However if stem cell treatment fails, joint replacement can always be performed at a later time. While good results have been obtained with moderate arthritis, results are not as good for severe or bone on bone arthritis. About half of such patients have had good results in our hands.
However, studies have shown that injecting a greater number of stem cells produces better results. Numerous papers have been published using this more advanced technique. There have been no reported adverse results in any patient, and all studies have shown efficacy. However, FDA regulations preclude us from performing this procedure, in which fat is digested with an enzyme called collagenase, removing lipids and fibrous tissue and thus allowing concentration and injection of a greater number of stem cells.
To allow our patients the benefit of this safe and more effective procedure we partnered with a leading clinic in Nassau Bahamas where their stem cell ethics committee allows proven safe procedures such as this to be performed after appropriate approval. Since November 2019 we have been making this more effective stem cell treatment available to our patients who can be treated by taking a 30’ plane trip to Nassau. Patients fly in the day before and may fly back the day after treatment – although many choose to stay to enjoy the ambiance in Nassau. These have been patients with severe arthritis for whom we recommended this more advanced procedure rather than the one we presented at Marseilles. There is also evidence that injecting these stem cells intravenously can help so called inflammatory arthritides such as rheumatoid arthritis, lupus arthritis, crohn’s arthritis and psoriatic arthritis. Our preliminary results have been good.
All stem cell patients are part of our ongoing research study. All are evaluated before treatment and then at 6 months, 1 year and each year thereafter. This allows us to generate scientifically valid publishable data – such as we presented at Marseilles – so that we are practicing true evidence based medicine. In emerging fields such as stem cell treatment this is necessary to properly inform patients of the likely benefits of treatment. We are one of the few centers who does this. This is because it is very expensive to do and time consuming. However our research foundation, the foundation for Orthopaedics and Regenerative Medicine (TheFOREM.org), has an excellent staff of researchers operating under my direction, who call each patient and calculate rating scores from validated rating instruments, to each patient – generating data that is published in leading medical journals. This foundation has been funded by me personally until now, however we are seeking outside support to allow us to continue to expand our studies.
The most important take away message is that a majority of patients that I see who are joint replacement candidates, often as second opinions, are able to successfully avoid joint replacement surgery for a period of years: and indefinitely in many I believe. As these stem cell techniques evolve these results will continue to improve. Our data from a spectrum of stem cell treatments is critical in allowing evaluation of relative efficacies of these procedures.