Stem Cell Enhancement Therapy
Posted on April 17, 2016
You’ll be pleased to know that not only are we experts in the standard treatments for sports & musculoskeletal injuries but also in the newest treatment methods, such as stem Cell Enhancement Therapy. One of the most exciting recent developments in the treatment of chronic musculoskeletal conditions is harvesting the power of adult stem cells.
Dr. Tortland was the first in New England to offer this treatment, and he remains the region’s leader in office-based stem cell treatment for musculoskeletal conditions. In fact, he was the first person in the United States board certified in Regenerative Medicine by the American Academy and Board of Regenerative Medicine. He sees patients from all over New England and beyond.
An Important Word About “Stem Cell Treatments.”
Unless being performed as part of a specially approved study, NO practice in this country legally can provide “stem cell” treatments, according to both the FDA and the FTC (Federal Trade Commission). This is because the term “stem cell treatment” very specifically refers to a treatment that consists entirely of stem cells. The problem is that there is no currently approved method that can be used by physicians in practice that completely isolates and concentrates stem cells.
As noted below, stem cells can be obtained from bone marrow and from fat. But what’s harvested from the marrow or fat is NOT pure stem cells – they both contain a mixture of many different cell types, including stem cells, other blood cells, as well as proteins, enzymes, etc. While stem cells may be a major component of these products, they are not allowed to be called “stem cell treatments.”
Nevertheless, these products still are very powerful and natural initiators of the tissue repair and healing process.
Now, here’s another fascinating – and shocking – reality. Only 1-2% of the stem cells that are injected actually differentiate into new tissue! In reality the injected cells actually trigger or stimulate the local resident stem cells in the target area to “activate” and differentiate into new tissue. The injected cells also release signals that attract stem cells from other parts of the body to the target area.
This is why we call these “Stem Cell Enhancement” treatments.
What are Adult Stem Cells?
Stem Cells are undifferentiated cells that have the potential to become other, more specialized types of cells. Stem cells are broadly categorized as either “embryonic” or “adult.” As the name implies, embryonic stem cells are derived from human fetuses, whereas adult stem cells are obtained from, well, adults!
Currently there are many proven therapies using adult stem cells, while there are none using embryonic stem cells. This is in part because scientists have had tremendous difficulty controlling how embryonic stem cells differentiate; they have a nasty habit of causing tumor formation, including teratomas. Adult stem cells, on the other hand, do not suffer from this pitfall.
Stem Cells are multipotent cells that can differentiate into a variety of cell types, including:osteoblasts (bone cells), chondrocytes (cartilage cells) and adipocytes (fat cells). This has been demonstrated in ex vivo cultures and in vitro or in vivo. Stem cells are obtained from the bone marrow, most commonly the back of the iliac crest (the “hip bone”), and from subcutaneous fat.
Stem Cells can differentiate into many different cell types, as indicated in the diagram below.
How Are Stem Cells Obtained?
Harvesting Stem Cells for injection therapy is done right in the office. As noted above, the most common sources are bone marrow and subcutaneous fat.
The skin is numbed first with a little Novocain. Next, the hip bone is numbed with more Novocain. A special needle is then passed through the cortex of the bone into the marrow cavity. This is a painlessprocedure in most cases. The liquid marrow is then very slowly drawn into a syringe. Once an adequate amount of liquid marrow is obtained, the needle is removed and a bandage applied. (Click here to see an animated video of how this is done.)
Stem cells can also be obtained from subcutaneous (beneath the skin) fat. The fat layer is gently numbed with an anesthetic solution using a gentle and minimally invasive technique. Once the fat layer is sufficiently numbed a small amount (about 2-4 tablespoons worth) of fat is aspirated using a gentle, almost pain-free liposuction technique. The fat is then processed on our office-based lab while you wait. The processing washes the fat to get rid of the oil and blood contaminants and then breaks up the fat into microscopic sized particles. This allows the various components of the fat – stem cells, pericytes, cytokine proteins, etc – to be liberated and available to perform healing and regenerative work. (Click here to see an animated video of the procedure.)
Which source is chosen – bone marrow or fat – depends on a number of factors, including the intended purpose of the treatment and the age of the patient.
Important note about SVF: Regarding fat, you may encounter various practices that advertise the use of fat-derived “SVF.” SVF is the Stromal Vascular Fraction of fat – what remains after the actual fat is removed by enzymatic digestion.
There are 2 problems with SVF. First, the FDA has made it abundantly clear that it is illegal for physicians and practices to digest fat to create SVF, in spite of what these clinics will say. Those that are using SVF are doing so at great peril. Second, digesting the fat with enzymes to create the SVF destroys some of the most important biological features of fat! So rather than being a better source of regenerative cells, it’s actually less effective!
How Are Stem Cell Injections Given?
All of our injections are given under direct ultrasound guidance. We first numb the skin with a little Novocain. Then, using ultrasound, we guide the needle to the precise location and inject the regenerative solution. The ultrasound guidance insures both accurate and safe injections. (Dr. Tortland is nationally-recognized expert in musculoskeletal ultrasound.)
What Are Patients Saying?
Here are some unsolicited testimonials from patients . . .
“Hi Dr. Tortland; my stem cell therapy from early November [3 months ago] seems to be working. My knee feels much better and I can walk and stand for longer periods of time without additional pain and swelling. Thanks for doing such a great job! I am back with Greater Boston Track club running 200m and 400m events”
What Conditions Might Benefit From Stem Cell Enhancement Injections?
Stem cell injections are most commonly used for the treatment of conditions that have failed or responded incompletely to other more conservative treatments. Conditions include, but are not limited to:
- Osteoarthritis of the joints
- Chronic partial Rotator Cuff tears
- Persistent partial tendon tears, such as tennis elbow, plantar fasciitis, quadriceps and patellar tendon tears.
- Partial muscle tears
- Meniscal (cartilage) tears in the knee
- Chondromalacia patella (patellofemoral syndrome)
Are There Risks Associated With Stem Cell Treatment?
Any injection is potentially at-risk for causing infection, bleeding, nerve damage. Risks will also vary depending on the structure(s) being injected. However, because we are using your own cells, you cannot be allergic to the treatment! Also, because the injections are done under ultrasound guidance, the risks of damaging surrounding structures, or of injecting the wrong location, are almost completely eliminated. Your doctor will review the complete risks of treatment with you. Nonetheless, the risks of treatment are extremely low.
Are Stem Cell Treatments Covered by Insurance?
Currently stem cell injections are still considered experimental. Most insurance plans, including Medicare, do NOT pay for stem cell injections.
When Can I Expect to See Improvement?
On average, most patients start to see signs of improvement approximately 6-8 weeks after the completion of the complete treatment protocol. This can be less overall pain, an ability to do more activity before pain sets in, and/or faster recovery from pain.
What is the Success Rate?
Studies suggest an improvement rate as high as 80-85%, though some arthritic joints, namely the hip, do not respond as well. Some patients experience complete relief of their pain. In the case of tendon and ligament injuries the results are generally permanent. In the case of joint arthritis, how long the treatment lasts depends partly on the severity of the condition. Mild arthritis may not need another round of treatments. More advanced arthritis, on the other hand, typically requires a repeat course of treatment, usually in 1-3 years.
The anecdotal experience in our office closely mirrors that of published studies. Regarding arthritis, our experience is that knees and shoulders respond the best, with 80-90% of patients experiencing improvement. 60-70% of patients with hip arthritis have a positive response.
In our office the vast majority of stem cell treatments are done for arthritis, with far fewer being done for tendon injuries. (Tendon and ligament injuries respond so well to the much less expensive PRP treatments that stem cell treatments are rarely necessary.)
See “What Does the Research Show?” below for more data on success.
The goal of treatment is to reduce pain and to improve function. While there is some weak evidence that treatment occasionally does result in increased cartilage thickness, the important point to keep in mind is that the cartilage lining the joint surfaces has no pain fibers! For example, often we see patients with knee or hip arthritis where the joint that does NOT hurt has WORSE arthritis on x-ray! Pain from arthritis is very complex and involves far more than just how thick the cartilage is.
This is a frequently asked question. In the case of mild arthritis,stem cell treatment may halt the development of further arthritic decay. However, in advanced arthritis, as noted above the goal of treatment is to reduce pain and improve function. In some cases the arthritis is so severe that stem cell treatment is not a viable option. In severe or advanced osteoarthritis stem cell treatment may help delay the eventual need for a joint replacement, but it is rarely a treatment that eliminates the need for it. Some patients are not surgical candidates because of other medical conditions. Other patients simply do not want joint replacement surgery under any circumstance. In these cases stem cell treatment may be a viable treatment option, but it is not a permanent solution in these specific situations–treatments will need to be repeated periodically (typically every 2-3 years). However, at the very least, research suggests that the improvement in symptoms seen with stem cell treatments roughly equals that seen with joint replacement.
At Valley Sports Physicians the cost of stem cell treatment is based on the level of complexity involved in treating a given area(s). In addition, the cost of the stem cell treatment reflects the cost of the complete treatment protocol, as outlined below:
- Pre-stem cell prolotherapy or Prolozone treatment (for arthritic joints only): $200-$400
- Stem cell treatment: $3500
- Post-stem cell PRP treatment (for arthritic joints only): $700-$900
What Does the Research Show?
As of June 2014 there were over 400 studies in various stages of development investigating the use of MSCs (and over 4450 studies on “stem cells”), according to the web site www.clinicaltrials.gov.
The clinical use of stem cells is far outpacing the research support of such use. That doesn’t mean that stem cells are not helpful. Rather it means that the research has not yet caught up to the use; stem cells are being used for many conditions for which stem cells have not yet been studied. By far, the most research on the use of stem cells for orthopedic conditions has been on the knee. The problem is that many studies look at the use of stem cells combined with surgery, vs. the use of stem cells by themselves.
The following is a brief, and certainly not exhaustive, review of some of the research regarding the use of autologous adult stem cells injections for the treatment of various orthopedic conditions.
(For an excellent review article on the use of mesenchymal stem cells in arthritic disease, click here.)
In a 2013 study by Koh et al, 18 middle-aged men & women underwent a single injection into an arthritic knee (Kellgren grade 3 or 4 arthritis) using fat-derived stem cells combined with PRP. Patients were evaluated at 3, 12, and 24 months after injection. There was a significant improvement in pain and function scores. In addition, repeat MRI at 24 months showed an increase in cartilage thickness compared to pre-treatment MRI. (Koh et al. Mesenchymal stem cell injections improve symptoms of knee osteoarthritis. Arthroscopy. 29(4);2013:748-755.)
Kim et al in 2014 looked at patients suffering from Grade 1-4 knee arthritis. Subjects were treated with bone marrow derived MSC combined with fat grafting. There was a significant improvement in pain and function. The severity of the arthritis made a difference – those with more severe disease did not respond as well.
Jo & colleagues injected the knees of 18 subjects suffering from arthritis pain using high-dose adipose-derived stem cells. They measured pain & function before & after treatment. They also performed a second-look arthroscopy to look at the actual effects of treatment on the cartilage. The results showed improved function and pain of the knee joint without causing adverse events, and reduced cartilage defects by regeneration of hyaline-like articular cartilage. (Jo et al. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis: a proof-of-concept clinical trial. Stem Cells. 2014; 32(5):1254-1266.)
In 2013 Orozco et al performed a single bone marrow stem cell injection into the arthritic knees of 12 patients who had failed conservative treatment. Patients exhibited rapid and progressive improvement that approached 65% to 78% by 1 year. Additionally, MRI re-evaluation at 1 year demonstrated a highly significant decrease of poor cartilage areas (on average, 27%), with improvement of cartilage quality in 11 of the 12 patients. (Orozco et al. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: A pilot study. Transplantation. 2013; 95(12):1535-1541.)
KNEE MENISCAL CARTILAGE:
Vangsness looked at stem cell injections for meniscus regeneration in 55 patients in 2014 compared to an injection of hyaluronic acid (HA). Patients underwent arthroscopic menisectomy. 7-10 days after surgery each received a single injection of MSCs. Patients were followed to evaluate safety, meniscus regeneration, the overall condition of the knee joint, and clinical outcomes at intervals through two years. Evaluations included sequential magnetic resonance imaging (MRI). There was evidence of meniscus regeneration and improvement in knee pain following treatment with the mesenchymal stem cells. in addition, patients with osteoarthritic changes who received MSCs experienced a significant reduction in pain compared with those who received the HA. These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects. (Vangsness CT, et al. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8.)
The are currently no published studies that have looked at the use of stem cells alone for the treatment of rotator cuff in humans. There are several studies that looked at the inclusion of stem cells in the surgical repair of cuff tears. Moon et al presented their data at the 2010 meeting of the American Academy of Orthopedic Surgeons. They showed that incorporating bone marrow-derived MSCs in surgical cuff repair resulted in faster healing & recovery than surgery alone.
In data presented at the 4th annual Orthobiologic Institute symposium (TOBI 2014, Las Vegas, NV) John Schulz MD of Regenexx showed that, in their experience, approximately 70% of patients with rotator cuff and/or labral injuries treated with same-day bone marrow stem cells experienced an average 70% improvement at 14.8 months.
In 2013 Huang et al looked at the use of MSCs to augment Achilles tendon surgical repair in rats. The results showed increased tendon strength.
OTHER ARTHRITIS DATA:
In a lecture given at the 4th annual Orthobiologic Institute symposium (TOBI 2014, Las Vegas, NV) John Schulz MD of Regenexx/Centeno-Schultz Clinic shared their data on the treatment of 1400 patients from 2005-2014 using same-day bone marrow stem cells for various orthopedic conditions.
According to them: For knee osteoarthritis (OA) they found that 80% of patients treated experienced an average 80% improvement, irrespective of arthritis severity, body weight, or age. Hip, shoulder, and ankle arthritis did not fare as well in their experience. 70% of patients with shoulder OA had slightly better than 50% improvement at 1 year. Barely 60% of patients with hip arthritis saw meaningful improvement, with older patients faring more poorly than younger. 60% of those with foot/ankle OA saw about a 45% improvement at 17 months. Patients with severe hand/wrist OA saw an average 40% improvement at 10 months (they did not indicate what percentage of hand/wrist patients overall had a positive response).
Steve Sampson DO, of the Orthohealing Center, also presented the results of their experience at the same TOBI meeting noted above. According to their data, they saw the following results in response to bone marrow-derived stem cell treatments (all percentages are averages): Both knees, 80% improvement; one knee only, 67% improvement; shoulder, 63% improvement; Hip, 50% improvement; Ankle, 44% improvement; All other joints, 70% improvement.
Autologous stem cell enhancement treatment can be a safe and excellent option for persons suffering from painful arthritis, chronic tendon & ligament tears, and other painful musculoskeletal conditions. However, as noted above, the field of Stem Cell research is still very new; in many ways it is still the “Wild West” out there! Patients are therefore encouraged to choose providers who:
- Have experience and a proven track record
- Perform injections under guidance (either ultrasound or fluoroscopy, and are experienced in these techniques as well)
Finally, do not choose a provider based solely on the cost of a procedure. The most expensive procedure isn’t necessarily the best one, and the least expensive one isn’t necessarily the least effective!