The short answer is yes, but let me explain the basic science behind this 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.
You may wonder why adult and not embryonic or young adult 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 these 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 adult stem cells, and especially adipose derived stem cell treatments if they are not cultured and/or manipulated. Thus, the one thing adipose derived stem cells will not do is to cause malignant transformations.
The FDA has stated that Adipose Derived Stem Cell therapy is under the "practice of medicine" as long as the cells are harvested from the same person, and they are re-injected into the patient during the same setting with little to no manipulation and or amplification of the cell. This is exactly what we are proposing to do in this procedure.
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. Only about 6 of these are for ADSC for the knee. 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. I have attached a copy of the slide presentation of these studies for your review. The current study we are conducting has already begun enrollment and is a self funded, un-blined, 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 at this link:http://www.clinicaltrials.gov/ct2/show/NCT01739504?term=ageless&rank=1
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. More recent peer reviewed published studies also 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 year)s, 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 reduced their knee pain and increased their overall physical function over a 2 year period and interesting enough, the patients tended to improve more as time progressed. 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 manufactured product of stem cells taken from someone else and injected into knees after a surgery was performed to remove a portion of the patients meniscus (which is a cartilage ring in the knee). The placebo group received a sodium hyaluronate ( Supartz) injection and the invertention 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 Supartz 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?
Patients qualifying for the initial study will have a thorough orthopedic exam and appropriate studies done at our office. A separate institutional review board ( IRB) approved consent will be reviewed and signed. Most patients will not generally require the supervision of an anesthesiologist since the procedure is done through a simple local anesthetic fluid. , Some patients will be administered oral Ativan (muscle relaxer) if necessary within an hour of the procedure. There is no need to start an IV or antibiotics since these will be given by mouth about an hour prior to the procedure. The proper extremity and abdomen will be initialed. The patient will be taken into an OR suite. The abdomen will be sterilely peeped and draped. A scrub nurse will help with the procedure. A small incision will be 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 effect. Excess tumescent fluid is gently rolled out of the remaining tissue and the portal sites. A light dressing is applied. In some patients a circumferential compression dressing is used. During this procedure, four 10cc tubes of blood are taken for preparation of the platelet rich plasma. The entire process takes about 30 minutes. The patient can be taken to the recovery area and eat if they wish. A registered perfusionist, who has received personal training in this procedure, processes the adipose tissue and blood. She will follow the 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. 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). We can also sample the final product and preform cell count and viability studies with the use of a video microscope. The patient can be brought into the pre or post surgical area and injected with this mixture into the corresponding joint. Discharge instructions regarding the care of the liposuction area will be given to the patient prior to the procedure. 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. .
If you are wondering about proper training of the phlebotomist and surgeon, I have already completed an accredited course in May of 2013. We have also had personal supervision of this entire procedure by a trained specialist in November of 2013. The entire process is formatted in standard lab protocols which need to be followed and initialed after each step. The completion of these steps are recorded in the patient chart for latter review if necessary. This laboratory process has been developed by one of the top 25 stem cell specialists in the world. She has been involved in the development of stem cell technology for over the past 10 years and sits on numerous government and academic review boards. An on-line article about her accomplishments can be found at this link: http://finance.yahoo.com/news/biohearts-kristin-comella-named-50-123811154.html
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 hyaluronic 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. If you choose not to proceed with this treatment, we can always discuss other surgical and non-surgical options. Obviously, if you have questions or concerns, please feel free to contact me, I will be more than happy to discuss them. You can contact our office anytime to schedule an appointment.
If you are interested in a personal one-on one evaluation by Dr. Loniewski, please call 248-893-3200 for an appointment.