FAQ for stem cells: What are stem cells? Stem cells, also referred to as progenitor cells, are undifferentiated or unspecialized cells that are defined by their ability to reproduce themselves (capable of self-renewal) and form a number of more specialized cells (capable of multi-lineage differentiation). What is the difference between adult stem cells, embryonic stem cells and induced pluripotent stem cells? Over the course of around seven years, every cell in the human body will die and new ones will replace them. This is made possible by the stem cells that remain in the body throughout one s lifespan known as adult stem cells. These are different from embryonic stem cells that are created through in vitro fertilization techniques or fetal tissue creating controversy and even safety issues. One common type of adult stem cell is the mesenchymal stem/progenitor cell (MSC), which is also known as a perivascular cell (meaning they line the blood-vessels throughout the body). These are found in large numbers in tissues like bone-marrow and adipose (fat). These cells are capable of forming mesodermal lineage tissues that include bone, cartilage, fat, tendon and most other connective tissue types. This capability is what interested researchers originally, however, it has been shown recently that these cells have many other characteristics that make them useful in medical treatments. They have the ability to modulate the immune system and decrease inflammation, coordinate tissue repair through paracrine signaling (cell to adjacent cell communication), and increase proliferation of cells (while decreasing apoptosis, programmed cell death) by secreting trophic factors (growth factors, proliferation signals etc.). Another commonly researched cell type is the induced pluripotent stem cell (ipsc) which is a simple dermal fibroblast (lower layer skin cell) that is taken from a skin biopsy, then cultured with special gene transcription regulating factors that de-differentiate the cell into what is essentially an embryonic stem cell. These have the advantage of avoiding ethical and moral controversy, but still have serious safety risks and are not well enough understood to be used widely in medicine yet. What is regenerative medicine? Regenerative medicine is a relatively new field of medicine focused on using the body s natural healing mechanisms to create drugs, therapies, and devices. It is a fairly general term that has been used in reference to anything from biological drug therapies to immune system replacement. Many regenerative medicine practices are based around the use of platelet-rich plasma (PRP) and stem cell based treatments. Are there cancer-causing risks associated with stem cell transplant? [Currently there is an increased risk of cancerous growth with the use of embryonic and induced pluripotent cells limiting their use in human patients. We do not use either cell type]
While the actual clinical use of adult stem cells in humans is relatively new, there are a good number of cases that have tracked safety data for these treatments (adult stem cell based), and none have shown an increase in cancer rates beyond the normal population risk. In the cases where adult mesenchymal stem cell patients do develop cancer, it has never been directly linked to the treatments (smoking, radiation, obesity and other factors present were much more likely to have increased cancer risk). So, no - current mesenchymal stem cell based treatments do not appear to increase the risk of developing cancer. How are the stem cells harvested? Are there legal and moral issues?? The stem cells are extracted from the patient s own bone-marrow through an extraction procedure that is widely used and a common practice for bone-marrow donations and transplants. Due to the transplant like nature of this procedure, and the fact that there is no donor required (same patient, same procedure) there are no blatant moral or ethical concerns. While you may have heard of the FDA cracking down on stem cell clinics, the legal issues surround adipose stem cell harvest, cultured cells, and allogeneic (donated from another patient) cells. The bone-marrow concentrate procedure used at PSCI avoids these regulatory issues by not introducing anything foreign to the final product, and not changing the characteristics of the cells contained in the concentrate. This minimizes safety concerns and results in the procedure not being considered a drug therapy by the FDA like adipose and cultured products are. Is there a risk of the transplanted cells being rejected? No. The main procedure we perform at PSCI is the extraction of bone-marrow from the patient, then taking the concentrated form of that bone-marrow and injecting it into the same patient during the same procedure. Since it is your own cells being transplanted there is no risk of rejection. It should be noted, that even with some MSC treatments that use donor cells from another patient, the immunemodulatory properties and lack of surface antigens (that signal the immune system to attack) decreases if not eliminates any severe rejection reactions, demonstrating the safety and potential of these cells. What happens during the procedure? For the bone-marrow concentrate based MSC therapy, the patient is given IV fluids and antibiotics to prevent procedural complications. Once in the procedure room, the patient is given mild anesthesia to minimize pain while keeping the patient responsive. A special needle is then inserted into the posterior iliac crest (the large part of the hip bone in your lower back area), and a syringe is attached to the top of the needle through which around 55-60mls of bone marrow is removed. The bone marrow is placed in a specialized sterile centrifuge tube designed to extract all of the good cells from the bone-marrow, which is then spun down in the centrifuge. The cells are then removed into sterile syringe and then injected into the problem area/joint using a special instrument called a fluoroscope or C-arm to ensure accurate needle placement. The process takes around 30 to 45 minutes, followed by an approximately equal time to recover from the sedation. Patients are able to go home shortly after the procedure (with a friend or family member driving).
How do the stem cells know what to do? As discussed in an earlier question, these MSCs have the ability to home-in on sites of inflammation by interacting with the inflammatory signals and by-products in their environment. This allows them to move to the areas of greatest damage where they counter-balance the inflammatory signals to bring down inflammation. They then secrete damage repair signals and growth factors to coordinate the remaining cells to repair the damage and regain normal structure. The cells have appropriately been likened to the general contractor of a construction project. They hire others to perform specific functions in the process, they manage the budget, and they provide materials for the process. The MSCs manage damaged areas in the body much in the same way by communicating with other cells and providing the proper materials and signals to finish the job. The special regulatory properties of MSCs make them ideal for this, because other biologics and drugs do not have the ability to directly respond to environmental changes like the cells do, preventing scar tissue formation and poorer healing outcomes. Are there any medical issues that may prevent me from receiving stem cell therapy? Yes. However, whether a given condition will completely eliminate you as a candidate depends largely on your medical history, and all concerns should be addressed with a doctor prior to receiving treatment. Patients with active uncontrolled cancers, HIV or Hepatitis infection, and pregnant woman should typically avoid stem cell treatment. Allergies to anything used in the procedure can cause complications as well, but can typically be mitigated through proper communication with the doctor about your specific allergies so things that might trigger them can be avoided. Some conditions are not adequately treated by MSC injections also. In the spine specifically, conditions that cause instability and nerve root compression (recent herniations, stenosis, spondylolisthesis, etc ) are not properly treated with stem cell injections, and may cause complications. In general, for most orthopedic treatments, acute conditions like fractures and tendon/ligament tears require time and sometimes surgical repair before stem cells can be used. In minor tendon/ligament tears and inflammatory injuries like tenniselbow that do not require surgical reattachment or repair, stem cells can be effective at promoting proper healing though. Who performs the procedure? One of our pioneering and experienced physicians will actually be removing and re-injecting the bonemarrow, and our efficient and professional support staff will be present to ensure everything goes smoothly and no issue goes over-looked. As one of the original regenerative medicine clinics, and an active research institution we are able to stay on the cutting edge, while contributing to the improvement and optimization of these treatments. We take pride in our product, which is improving the lives of our patients in a comfortable and safe environment, and as such, only accept the best from our doctors and staff. Is this procedure covered by insurance?
Currently it is not. It is a long process to get new treatments (even FDA approved ones) covered by insurance due to the companies need to minimize risk to maintain the bottom-line. In the future, however, all signs seem to indicate that this procedure will eventually be covered because evidence for safety and cost effectiveness (much cheaper than open-surgery or total joint replacements) is piling up gradually. That is not, however, a directive to try and wait until it is covered, because the process is agonizingly slow and could take years still. We try to keep track of data for all our patients in an effort to speed up the process by providing more and more evidence of the procedures success. In the meantime, we offer different payment strategies to make this procedure available to those who need it. How do I know if I am a good candidate? Typically, for orthopedic stem cell treatments, it is very helpful to have MRI and X-ray images that the doctors can analyze to determine whether the treatment is a good idea or not. These can be provided by mail, email, fax or other means, after which the doctor will view them and call to discuss your options. Ideally, for those who are local to our area, an in office consultation where the doctor can do a physical examination of your condition is the best way to determine candidacy. If you are not a good candidate for the procedure, our doctors are all experienced and trained orthopedic specialists who can offer their guidance on other treatment options available to you. Before the procedure, what should I plan for? If you decide to schedule a procedure, we ask that you arrange to be picked-up afterwards, and plan for around 2 hours for prep-time, the procedure, and recovery time. We ask that you avoid antiinflammatory medications, supplements etc. for a week prior to the procedure. If you take any bloodthinning medications (anticoagulants like aspirin, warfarin, heparin, xarelto, fish oil etc.) please make arrangements with the prescribing doctor to give you plan to stop these at least a few days before and after the procedure to avoid bleeding risks. You should make a list of all the medications and supplements you are taking so the doctor can adequately advise you on interaction risks during the procedure [NOTE: Providing a complete list is VERY IMPORTANT. If you lie about, or neglect to inform the doctor of all current treatments and medications you are taking, there can be life-threatening complications all information provided is strictly confidential] As is standard for patients receiving anesthesia of any kind, please refrain from eating or drinking anything besides water for 8 hours prior to the appointment. We will provide a supportive brace for you following the treatment to help aid the process. What should I expect after the treatment? While we have had many patients report feeling much better immediately following the procedure, this varies from patient to patient. We recommend you keep active, but restrict activities to light low-impact activities for around two weeks following the treatment. This is because the fluid volume is increased in the injected area for several days following the procedure, and there can be residual inflammation as well. You may feel like there is a bruise (pain and swelling) at the site of bone marrow extraction, and many patients report a full feeling in the injected area for a few days after the injection. These dissipate fairly rapidly (if you have lasting pain, fever, abnormal redness, itching, heat or swelling near
the injection site, please let the doctor know right away). Longer term recovery is a little more variable based on the nature and severity of the issue being treated, and our general recommendation is to avoid activities that reproduce your original pain or aggravate the treated area(s). We do recommend a structured exercise program, and suggest physical therapy to maximize the results from your injection, as with all orthopedic injuries it is helpful to strengthen and exercise the surrounding joints and muscles (this could include core-strengthening for low-back treatments, and quad and hamstring strengthening for knee and hip injuries). Generally, most patients see the most results in the first 3-6 months, especially those that take an active role in their recovery plans. How effective are these treatments? Based on our research, and studies on similar treatments, patients typically improve on their pain and functional scale scores by 60 to 80% (on average, some have no pain or 100% improvement, while some see less). For those wishing to avoid surgical treatment, we typically see greater than 80% of patients avoid surgery through 2 years post-procedure (and in one study, of those that did choose to have surgery, only 20% saw improvement following the surgery). How often do I need to receive injections? For the majority of our patients, a single injection tends to have lasting results, and is therefore the only procedure necessary. There are some patients, though, that may have lower cell counts at the time of the procedure that do not see optimal results. In many of these patients we have offered re-injection at a discounted rate, and the results following the second injection are usually greater than the first. So you can reasonably expect to only need one treatment, and in rarer cases two, to see full results. What happens if I re-injure the area, or develop a condition that aggravates the area I had treated? We have had a few patients that have gotten in accidents, had injuries, or developed other conditions that cause joint pain. For example, one patient had a bone cyst grow in a spinal level adjacent to the treated level that caused similar pain to the originally treated condition, and a growth like that typically needs to be removed surgically. Depending on the injury or condition, it may be again treatable by stem cell injection, however the process essentially starts from the beginning in that, your injury would need to be evaluated to see if it is treatable, and some cases may necessitate other treatments as well (like a broken bone or torn ligament). Fortunately these types of events are no more common than they are in the general population, and can typically be avoided. Other than orthopedic problems, what conditions can be treated by stem cell injections? We recently (a little over a year ago) began to offer adjunctive IV stem cell therapy for our orthopedic patients, and began to see unexpected benefits for those with other conditions in addition to the orthopedic issue. The treatments for these other conditions are still in the early stages, but there are numerous pre-clinical (lab and animal based) studies showing the potential of systemic stem cell therapy in several of them. For some, there is even some early (phase I) human clinical trials that have demonstrated the relative safety and efficacy of these treatments. These potential therapeutic targets
for stem cell injection include Parkinson s Disease, Multiple Sclerosis, Crohn s disease, systemic lupus erythematosus (SLE), fibromyalgia, and rheumatoid arthritis. One common element to these conditions is the presence of an auto-inflammatory component where the body s immune system unnecessarily attacks its own tissues. Many of the preclinical studies on MSCs have shown they are able to minimize this immune response, potentially decreasing symptoms and progression in the above diseases. We are currently working on starting formal clinical trials to test these applications in order to better describe the potential benefits one might see. We currently can not make any statements to the efficacy of these treatments, but we do have several patients who have received IV treatment with their joint injections that have reported benefits.