Stem Cell Injection Therapy

You’ll be pleased to know that our doctors are experts in not only the standard treatments for sports & musculoskeletal injuries but also in the newest treatment methods, such as stem Cell injection therapy.  One of the most exciting recent developments in the treatment of chronic musculoskeletal conditions is the use of adult mesenchymal stem cells (MSCs).

Drs. Tortland & Kozar were the first in New England to offer this treatment, and they remain the region's leaders in office-based stem cell treatment for musculoskeletal conditions.  They see patients from all over New England and beyond. 

Please contact us to schedule an appointment. Our doctors can evaluate your injury and see if you are a candidate for stem cell injection therapy.


What are Adult Mesenchymal 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 over 70 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.

Mesenchymal stem cells
, or MSCs, are multipotent stem 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. MSCs are obtained from the bone marrow, most commonly the back of the iliac crest (the "hip bone").




MSCs can differentiate into many different cell types, as indicated in the diagram below.





How Are MSCs Obtained?

Harvesting MSCs for injection therapy is done right in the office. In most cases the stem cells are obtained from the bone marrow (they can also be obtained from fat; see below).  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 painless procedure 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.

The syringe containing the liquid marrow next is placed in a special centrifuge. The marrow is spun and the stem cells are highly concentrated and passed into a new syringe from which the injection(s) are given.

The entire procedure takes about an hour and is minimally uncomfortable.

How Are Stem Cell Injections Given?

All of our stem cell, PRP, and prolotherapy 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 stem cells. The ultrasound guidance insures both accurate and safe injections. (Drs. Tortland & Kozar are nationally-recognized experts in musculoskeletal ultrasound.)

Following injection, for weight bearing joints (ankles/feet, knees, hip) patients need to avoid bearing weight for 24-48 hours. But it is critical that the joint NOT be immobilized. Gentle protected movement is critical to stimulate healing. For non-weight bearing joints, gentle protected movement is generally encouraged, but forceful or aggressive activity, such as sports, is prohibited. Your doctor will give you more specific post-injection activity guidelines.

Treatment Protocol

In our office, in cases where the stem cells will be injected into a joint, we prefer to perform a dextrose Prolotherapy treatment first, 3-4 days before the stem cell procedure. The prolotherapy helps prepare the joint biologically for the healing process generated by the stem cells.

About 2 weeks after the stem cell procedure, a PRP injection is commonly given. This helps keeps the stem cells active. Another PRP treatment may then be given about 2 months later.

How Often are Injections Given?

In most cases, patients respond very well to just one round of treatment. However, 2-3 treatments may be needed in very severe cases. Treatments are never given more frequently than every 6-12 months.

What Conditions Might Benefit From Stem Cell 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.

Will Stem Cells Regrow New Cartilage In My Joint?

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.

Will Stem Cell Treatment Help Me Avoid A Joint Replacement?

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.

What Does Stem Cell Treatment Cost?

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 treatment (for arthritic joints only): $200-$400
  • Stem cell treatment: $3000
  • Post-stem cell PRP treatment (for arthritic joints only): $700-$900
  • Total Cost: $3900-$4300

Fat Grafting

In the case of moderate-to-large tendon and muscle tears, such as rotator cuff, tennis elbow, and Achilles, stem cell treatment alone may be less effective because the liquid stem cell solution has less tendency to stay in the tear; it leaks out. In order to combat this we often will combine stem cells with fat concentrate to create a gel that fills the defect and promotes more effective healing.

Likewise with more advanced joint arthritis, the fat acts a matrix to help hold the platelets in place and also helps activate them to release their growth factors more effectively. Think of a garden trellis that helps hold a growing vine in place. In fact, for moderate-to-advanced arthritis, our standard treatment is to combine the stem cell solution with the fat due to the fact that it seems to work that much better than stem cells alone alone.

The fat is harvested from the patient's belly, buttocks, "love handles," or hips using a gentle liposuction technique. (The amount harvested generally is NOT enough to have a cosmetic effect.) The fat is concentrated via centrifuge, and the resulting fat concentrate is subsequently mixed with the stem cells to create a gel. The gel fills the tear in the case of tendons/muscles, and helps maintain more constant contact with the joint surfaces in the case of arthritis.

Fat grafting adds an additional $1000 to the cost of treatment.

What Does the Research Show?

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.)

KNEE ARTHRITIS

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.)

ROTATOR CUFF:

The are currently no published studies that have looked at the use of stem cells alone for the treatment of rotator cuff.  There are several studies that looked at including 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.

ACHILLES TENDON:

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).

It is important to note that, unlike studies published in respectable peer-reviewed journals, Regenexx will not divulge specifics of their treatment protocols or bone marrow preparation methods, making meaningful comparison of their findings to other studies difficult.  For example, in the TOBI presentation, they present their protocol as involving a pre-stem cell injection consisting of a "pro-inflammatory" agent (not specified), a stem cell injection containing "proprietary BMC isolation technique with two different types of platelet mixes and FDA approved adjuvants" (again, none specified), then a post stem cell injection containing "two different types of platelet mixes and FDA approved adjuvants" (not specified).  Such a cryptic presentation eliminates the ability to compare their approach with other more transparent published protocols.