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From the Doc...
Stem Cell Therapy for Injured Joints... Fact, Fiction or Still Star Trek?
If Dr. Bones from Star Trek was an orthopedic surgeon in 2014, he might say "Damn it Jim, I'm a doctor not a cell biologist." Orthopedic surgery is definitely on a new frontier where cell biologists have actually been for about the past 10-15 years. But that new frontier means that orthopedic surgeons have to go back to their basic cell biology text books. Cell biology has totally changed the way we think about healing the human body. For the past 80-90 years, orthopedic surgeons have always believed that the best way to get the body to heal was to add more metal. It was like we were part of an SNL skit repeating that "I have a fever and the only cure is more metal!" However, over the past 9-10 years, there has been a that gentle nudge to shift the paradigm from steel to growth factors and from screws to mesenchymal stem cells.
So, let me explain the basic science behind this stem cell therapy and what it will and more importantly, what it won't do. Stem cells can be found in any tissue in the human body and we constantly use them to stimulate a regenerative process in our tissues every minute of the day. Stem cells can be harvested from many sites including bone marrow, synovial tissue, blood, skin, and fat.
It really does not matter where you harvest the cells from since adult stem cells are multipotent and can differentiate into a subclass of cells such as skin, cartilage, bone, and muscle. However, it does matter when we talk about the yield from the source of the stem cells. The higher the number of cells collected, the more potent the response for the regenerative process. Thus, it is a question of quantity. In adults, the highest concentrations of stem cells are found in abdominal adipose tissue. In fact, your abdominal fat contains 50 times more stem cells than your bone marrow per gram of tissue. In addition, your bone marrow has a steady decrease in the number and viability of stem cells as we age. Adipose tissue has a significantly higher density of cells that do not seem to decrease in density as fast as bone marrow with age. Finally, abdominal fat is plentiful; easily accessible with little morbidity; and is a source that continues to replenish itself as I can attest.
You may wonder why adult and not embryonic or allograft cells? Beside the fact that there is a huge moral and ethical issue with these cells, they also lead to malignant transformation with multiple replications. In fact, after 10 billion US government funded or backed dollars in research on embryonic stem cell lines, the best researchers can come up with is a teratoma that is a benign tumor of mixed cells. To date, there have not been any reported malignant transformations with autologous ( meaning from your own body) adult stem cells, and especially adipose derived stem cell (ADSC) treatments if they are not cultured and/or manipulated. Thus, the one thing autologous adipose derived stem cells will not do is to cause malignant transformations.
Now this brings up the question of efficacy. Do we have any evidence that this treatment is effective for arthritis of the knee? There are currently over 60 Institutional Review Board (IRB) open or completed studies utilizing adipose derived stem cells (ADSC) of arthritis registered at clinical trials .gov. Only about 6 of these are for ADSC for the knee arthritis. Other ADSC studies for CHF ( congestive heart failure), COPD ( chronic obstructive pulmonary disease) , erectile dysfunction, diabetes and ischemic limbs have all had positive results with no adverse outcomes directly related to the treatment. A current study sponsored by Ageless Regenerative Institute in Florida has already begun enrollment. This is a self funded ( meaning you have to pay), un-blinded, non-randomized, uncontrolled study evaluating the safety and efficacy of one single injection of the ADSC mixed with the patients own platelet rich plasma for a degenerative arthritic knee. This is sometimes known as a safety and efficacy trial. The outline of the study along with the inclusion and exclusion criteria can be found here: Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis (a neat article, even if the title is a bit of a mouthful!)
The preliminary results of this study look promising without any reported adverse events. However, the data pool is small and no conclusions can be made at this time. This study used the Visual Analog Scale (VAS), Short Form McGill (SF-MPQ) , and Present Pain Inventory (PPI). All of these questionnaires are standard forms used to evaluate the efficacy of different treatments for arthritis. The VAS had 103 patients showing an average 75% reduction in pain after 6 months. Both the PPI and SF-MPQ had a much smaller group of 18 showing a 75% and 60% improvement respectively.
A few recent peer reviewed studies have some promising results. Yong-Gon Koh and his colleagues in S. Korea published an article entitled : “Clinical results and second-look arthroscopic findings after treatment with adipose-derived stem cells for knee osteoarthritis” in the Journal of Knee Surgery, Sports , Traumatology and Arthroscopy, December 2013 issue. Dr. Koh treated thirty elderly patients, suffering from osteoarthritis of the knee with the same ADSC procedure and followed them closely for 2 years. He also took a second look of the knee through an arthroscopy in 16 of these patients. His published findings were the following: “Almost all patients showed significant improvement in all clinical outcomes at the final follow-up examination. All clinical results significantly improved at 2-year follow-up compared to 12-month follow-up (P\ 0.05). Among elderly patients aged (65 years), only five patients demonstrated worsening of Kellgren–Lawrence grade. On second-look arthroscopy, 87.5 % of elderly patients (14/16) improved or maintained cartilage status at least 2 years postoperatively. Moreover, none of the patients underwent total knee arthroplasty during this 2-year period. “ In plain English this means that almost all the people in the study had reduction of their knee pain and increased their overall physical function over a 2 year period. Interesting enough, the patients tended to improve more as time progressed. Meaning there seems to be progressive improvement rather than a tapering off effect. Best of all, none of the participants had their knee replaced! Another study published in the prestigious Journal of Bone and Joint Surgery ( JBJS) , January 14, 2014, Vol 96-A, No.2 by C. Thomas Vangsness Jr, MD entitiled “Adult Human Mesenchymall Stem Cells Delivered via Intra- Articular Injection to the Knee Following Partial Medial Meniscectomy” introduced some interesting findings. This was a nicely designed double blinded, placebo controlled, randomized trial of the use of a manufactured stem cell product taken from someone else (allograft) and injected into knees after a surgery was performed to remove a portion of the meniscus (which is a cartilage ring in the knee). The placebo group received a sodium hyaluronate (trade names Supartz, Hylagan or Synvisc ) injection and the intervention groups received different doses of the stem cells along with the sodium hyaluronate. Everyone was followed up with MRI’s and exams at six weeks, six months, one and two years. The MRI’s of the stem cell treatment groups revealed both an increase in the volume of regenerated meniscus tissue as well as a reduction of pain as compared to just the hyaluronate injection over a two year period without any adverse side effects. Although, this is a different technique, this study does reveal that stem cell injections can increase tissue growth of the meniscus and reduce pain in arthritis of the knee.
How is this procedure performed?
The procedure is done through a simple out patient procedure under a local anesthetic . A small incision is made on either side of the abdomen for entry of the local anesthetic. The abdominal area is numbed with a specially prepared fluid called tumescent fluid. A small liposuction tool called a Mercedes cannula is inserted. The liposuction is carefully performed in a fan wise motion on one side of the umbilicus removing only 30 to 60 cc of fatty tissue form each side of the abdomen to ensure even sculpting. However, the procedure is not designed to provide any aesthetic or cosmetic effect. During this procedure, four 10cc tubes of blood are taken for preparation of the platelet rich plasma. This platelet rich plasma is full of growth factors from the patient's own blood to act as a fertilizer for the stem cells. A registered perfusionist or laboratory tech, who has received special training in this procedure, processes the adipose tissue and blood. They follow a strict lab protocol washing the fat cells and spinning these down to produce the fractionated stromal layer containing the stem cells. Approximately 9-10 million stem cells will be harvested with most having around 90% viability. During this process, the platelet rich plasma is also prepared yielding between 4-5 cc of the special fertilizing fluid. The two are mixed together for the final process. The entire process is completed in one setting using a sterile hood; strict sterile technique; and a Current Good Manufacturing Process (cGMP). The patient is injected with this mixture into the corresponding joint. The entire process will take between 2-3 hours. Most patients take it easy with no heavy lifting for about 1 week to protect the abdomen but the joint can be used normally in 24 hrs. Most patients start to notice some improvement in symptoms in the 2-3 weeks and continue to improve over time.
In summary, this procedure appears to have a very good safety record and potentially more effective in the treatment of degenerative arthritis than standard treatments such as steroid or hyluronic injections. There is absolutely no guarantee that this procedure will eliminate arthritis pain, but the trends in current study populations appear to show some promise.
You may not be transported via the teleporter in your life time to fight Klingons, but you should experience the tremendous benefits of harvesting and using your own stem cells to restore function and reduce pain in your life time. The best part of this treatment, is that your own body produces this treatment rather than a drug company. It appears that God knew what he was doing with the human body way before Hippocrates, Jonas Sulk or even Captain Kirk were born.
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