Stem Cell Frequently Asked Questions (FAQ)
Latest revision: December 15, 2016
Please note that this information pertains only to how Laith Farjo, M.D. performs stem cell therapy procedures and may not represent the techniques or views of other physicians at Advanced Orthopedic Specialists who may also be performing stem cell procedures.
GENERAL INFORMATION AND SCIENCE:
What is stem cell therapy?
Stem cell therapy has been under intensive study for the last few decades; virtually every field of medicine is exploring its use. Essentially, we are harnessing the power of stem cells – the “building blocks” of all the cells in your body – to regenerate and repair tissue. This field of medicine – regenerative medicine – is revolutionary. Instead of giving you a foreign chemical (i.e. medication) or putting in a plastic-and-metal joint replacement, we are utilizing your body’s fundamental repair mechanisms and directing them to the site that needs the most attention. It is perhaps one of the most “natural” treatments we can provide in Medicine.
Why do you use bone marrow stem cells?
Bone marrow are easily obtained. They can be processed with minimal manipulation, per FDA guidelines. But most importantly, they are closer in cell lineage to cartilage and tendon than fat stem cells. That means they have less to differentiate (change) to become the cells we need them to. Finally, there are many more clinical studies documenting the efficacy of bone marrow derived stem cells as compared to adipose cells.
Where do you get the stem cells from?
We aspirate the stem cells from the iliac crest bone. The reasons for this is that it is rich in stem cells, is safely accessed, and patients typically have minimal pain or activity limitation due to the harvest.
Why not fat stem cells?
The main reason is the superiority of bone marrow stem cells, as noted above. However, the FDA is currently actively scrutinizing the techniques utilized to process adipose derived stem cells and is considering disallowing this practice because it may violate their “minimal manipulation” guidelines.
Why not placenta or umbilical cord stem cells?
While these “younger” stem cells may be more powerful, I am concerned about using another person’s live stem cells in my patients. There is increased risk for disease transmission, unusual tissue growth, or rejection. The vast majority of clinical studies have been performed using a patient’s own cells, primarily from bone marrow.
What about other procedures that I may have heard of, seen on TV, read on the internet?
Dr. Farjo prefers human clinical data for the procedures he performs – he does not believe in “experimenting” on his patients, nor basing treatment recommendations on lab or animal studies alone. As information on the safety and efficacy of new procedures becomes available, he will provide these options to his patients as he feels is appropriate. Dr. Farjo is not currently performing stem cell subchondroplasty because there are very few published studies documenting its efficacy.
Is stem cell therapy FDA approved?
The FDA has established a division to regulate blood products, known as the Center for Biologics Evaluation and Research. Under regulation 21 CFR 1271.15(b), treatment using a patient’s own blood products is allowed by the FDA. Numerous devices that prepare PRP have been FDA cleared. Stem cell therapy, if utilizing a patient’s own stem cells, and if those stem cells are “minimally manipulated” are also allowed by the FDA. The FDA still considers these treatments to be investigational.
Is this surgery?
We offer stem cell treatments in two different ways. Some treatments are a simple procedure performed in the office. Other stem cell therapies are performed in conjunction with minimally invasive surgery, such as arthroscopy. Dr. Farjo will recommend the best treatment for you based on the specifics of your condition.
PLATELET RICH PLASMA (PRP):
Is platelet rich plasma (PRP) part of the stem cell procedure?
Yes. Our system extracts a combination of both stem cells as well as PRP – you have the benefit of both being used to treat your condition. PRP contains numerous growth factors that stimulate stem cell proliferation and migration, as well as decrease joint inflammation.
What is the added benefit of additional PRP injections, after the stem cell therapy?
One PRP injection is performed as part of your stem cell therapy. For patients wishing to maximize the outcome of the stem cell treatment, we have found that two additional PRP treatments, approximately 1 month and 2 months after the stem cell procedure, have been beneficial. The PRP treatments are performed in-office with a simple blood draw. PRP contains many growth factors which act synergistically with the stem cells to encourage their growth and expansion. Think of stem cells like the “seed” and the PRP like adding “fertilizer”.
Why Dr. Farjo and not some other stem cell clinic?
There are many different types of physicians performing musculoskeletal stem cell therapy. Dr. Farjo is a board certified orthopedic surgeon. As an orthopedic surgeon, not only is he an expert on joint and muscle function, but also in the full diagnosis and treatment of musculoskeletal problems. The proper treatment of a patient begins first with an accurate diagnosis. Furthermore, Dr. Farjo can offer the full range of treatment for arthritis and tendon tears, not just injections. Many stem cell treatments work much better when any mechanical joint pathology is corrected at the same time. Orthopedic surgeons are the only ones who can offer such treatment, such as minimally invasive arthroscopy.
Within the field of orthopedic surgery, Dr. Farjo has extensive experience in joint preservation – that has been the focus of his practice for over 17 years. As a matter of fact, joint replacement has represented less than 5% of his practice throughout his career. Utilizing minimally invasive surgical techniques, in addition to stem cell therapy, he can obtain better outcomes than with either surgery or injections alone.
What is Dr. Farjo’s experience?
Dr. Farjo has performed hundreds of stem cell procedures. He is a board certified orthopedic surgery with subspecialty fellowship training in Arthroscopy, Sports Medicine, and Shoulder surgery. He has performed tens of thousands of surgical procedures in his 17+ year career. He has received numerous awards including Hour Magazine Top Docs and Castle Connolly Top Doctor (voted on by other physicians) as well as Vitals Patient Choice Awards (voted on by patients).
What are the problems we have successfully treated?
Dr. Farjo has personally used stem cell therapy:
• To treat arthritis of the knee, hip, elbow, ankle, and basilar joint of the thumb
• To improve the healing of rotator cuff tears after surgical repair
• To accelerate soft tissue healing in athletes, such as after repair of a torn labrum or tendon in the hip or shoulder
Can it fix a torn rotator cuff?
No. We do not have any evidence that simply injecting stem cells into a shoulder with a torn rotator cuff will heal the tendon. However, there is excellent evidence to show that using stem cell therapy in conjunction with repairing a torn rotator cuff significantly improves short and long term outcomes.
What makes me a candidate for stem cell therapy?
We base the recommendation for the therapy on multiple factors, including: your exact medical condition, failure of other treatment methods, joint alignment, age, activity level, and overall health.
Which ages can have the procedure? Can older patients benefit from stem cell therapy?
The quantity and quality of stem cells in your body slowly declines as you age. After the age of 70, there is a steeper decline. Dr. Farjo typically, therefore, recommends the treatment for patients aged 75 or younger for the treatment of arthritis. When used to improve healing after rotator cuff repairs, we do not have a specific age cut-off. Please note, that stem cell therapy is not harmful if performed after these ages, it may simply be less effective.
Do you treat out of town patients?
Yes – we routinely do this. Please contact Dr. Farjo’s scheduler at 810-299-8558 to discuss your specifics. Typically, we would have you send in medical information and x-rays/MRIs to determine if you are a candidate for the procedure. If you may require a surgical procedure in addition to the therapy, we would arrange an appointment the day prior to surgery so that Dr. Farjo can personally evaluate you, determine a specific plan, and discuss the procedure to be performed the following day.
If I have severe arthritis will this work?
This depends on many factors, and should be discussed with Dr. Farjo. He will not recommend this procedure if he feels it has a low chance of success.
Can I still have the stem cell procedure if I have had a hip replacement?
Yes, the iliac crest bone, where we obtain the stem cells, is not the bone that was replaced with your replacement surgery. It is relatively distant from your hip joint, anatomically speaking. We would not however, recommend injection of stem cells into the total joint site.
RISKS AND ALTERNATIVES:
Are there alternatives to stem cell therapy?
Yes – these include medications, activity modification, physical therapy, bracing, steroid or other joint injections, arthroscopy, and joint replacement surgery. We may recommend these to you instead of, or in addition to, stem cell therapy based on an individualized care plan developed at the time of your evaluation.
Should I try hyaluronic acid treatments before stem cell therapy?
We have been performing hyaluronic acid injections (eg. Supartz, Synvisc) for arthritis treatment for almost two decades. 70% of patients generally note symptom improvement for 6-12 months after the injections; sometimes we have patients have improvements lasting even longer. The advantage of these injections is that they’re done in-office and may be covered by insurance (for knee arthritis; other joints are not covered). However, they do not actually “treat” the arthritis – they make you feel better but have no capacity to change the course of the arthritis-the arthritis keeps "marching on". Whether you choose this route is dependent on whether you simply want to treat your symptoms until you need a joint replacement or whether you want to be more aggressive in fundamentally treating the arthritis in your joint.
What are the risks? Is it safe?
Numerous studies have shown musculoskeletal stem cell therapy to be safe. The risks of the procedure include infection, stiffness, swelling, or abnormal tissue growth. These risks are very rare. Other risks include swelling at the injection site or bruising at the bone marrow harvest location.
How did we select the system we utilize to process the bone marrow?
The system Dr. Farjo utilizes is capable of separating stem cells and platelet rich plasma from other blood products, such as red or white blood cells. These other cells may promote inflammation and counteract some of the beneficial effects of the stem cells. Furthermore, Dr. Farjo has had this system tested by independent scientists who proved that not only did the entire process produce good numbers of stem cells, but it also produced healthy stem cells that were capable of surviving a freeze cycle (see Stem Cell Banking below) and also capable of reproducing after reanimation.
Which company supplies the kits? Are they local?
Dr. Farjo is currently utilizing an Arthrex system. They are an international orthopedic company with local representatives. This may be subject to change at any time, as we always seek out the best and most effective technology.
Why is the bone marrow spun in the machine?
Part of the process of identifying the stem cells is centrifugation – this helps the machine to separate out the various components of your bone marrow to further identify the stem cells.
Should I stop any medications?
We advise you to stop any non-steroidal anti-inflammatory medications 2 weeks prior to the procedure. You may continue to take aspirin if you are taking it for a heart-related condition or preventative purposes. We would suggest taking Tylenol to help any joint pain you have during this time; if you require something stronger, let us know.
Will taking blood thinners impact the outcome?
No. You may have some more bruising at the site of bone marrow harvest, however.
May I have a steroid injection into my joint prior to the procedure?
Yes, as long as it is at least a month prior to the procedure.
Do I need to modify my activities prior to the procedure?
DAY OF THE PROCEDURE:
Does this all happen in one day? How long does it take?
Yes. If you are having an in-office stem cell procedure, the aspiration typically takes about 15 minutes. There is approximately 30 minutes of processing time to allow our team to identify the stem cells and PRP from your bone marrow. The injection thereafter into your diseased joints just takes a minute. If you are having this in conjunction with surgery, it is all performed while you are under anesthesia. To minimize the time you are under, Dr. Farjo typically will harvest the bone marrow early during the procedure so that the team can process it while he is performing the rest of your surgery.
Can I drive myself to the procedure?
We will prescribe you Valium and Norco to take prior to an in-office procedure – this allows for a more comfortable experience. You may not drive for typically 4 hours after taking those medications, or longer if your reflexes and judgment have not returned completely. Similarly, you may not drive home from the surgical facility if you are having the procedure with surgery; you will need to have someone with you during your time there. These medications also impair your judgment – we recommend that you not make any important personal, business, or financial decisions within 24 hours.
Am I awake with the procedure?
We perform the procedure in two different settings. 1) In office – You will be awake, but sleepy for the procedure. We numb the bone marrow aspiration site with lidocaine. 2) In conjunction with surgery – typically you are asleep. We are also able to offer stem cell procedures under deeper sedation in an operating room setting, if that is your preference.
Does it hurt while the procedure is being performed?
For in-office procedures, our patients on average have rated the discomfort an average of 4 on a scale of 0-10, lasting typically less than a minute. If you are having the procedure under anesthesia in the operating room, you will not feel anything.
Symptoms after the procedure?
The most common symptom patients experience is swelling. Some patients will have some mild pain. If you had a surgical procedure along with the stem cell therapy, you may experience additional symptoms, which we will explain to you in your consultation.
Activity modifications afterwards?
You are able to return to activities after 24 hours, but we ask that you refrain from high intensity exercise for 2 weeks. The medications we give you prior to the procedure affects your judgement, so we advise you not to make any important business or personal decisions that day.
Medication limitations afterwards?
We prefer you avoid anti-inflammatory medications (NSAIDs) such as Ibuprofen (Motrin, Advil), Naproxen (Aleve) for a total of 3 months following your procedure. You may take them on occasion, but it is best if you do not take them “around-the-clock”. We recommend you try Tylenol instead, if you don’t have any issues preventing you from taking it (eg. liver disease). You may resume all your other medications immediately.
When can I return to work? Sports? What to expect for recovery?
This is best discussed with Dr. Farjo or one of his physician assistants, because it will depend on the nature of your work or sporting activity, as well as the actual procedure you are having done. If you are only having a stem cell procedure, without additional surgery, return to work is typically the following day. We ask you to “take it easy” with regards to sports for a few weeks after the procedure. This does not mean you cannot be active, but we would prefer you avoid impact activities to the joint that was treated.
Why do I have these limitations?
When we use stem cell therapy to treat arthritic conditions, we are trying to grow new cartilage. Think of it like trying to grow a new grass lawn. You would not want to go run out on the newly sprouting grass right away. We do like the joint to see some “stress” – i.e. from everyday activities such as walking, or light activities such as biking – but we don’t want to “overburden” the healing cartilage.
What is the cost?
Our stem cell procedures start at $3500. There are discounts available for multiple joints performed in one day. Please note that these prices are subject to change – please call our office at 810-299-8558 for the latest pricing.
Is the procedure payable by health savings account?
Typically, yes. You should check with your plan administrator for more information and requirements.
Do we offer a payment plan?
Yes. Please contact our office for more details.
Does insurance cover the procedure? No. At this point, we are unaware of any insurers covering this procedure for musculoskeletal treatment, including workers compensation and auto insurers. Insurers typically do not pay for procedures that are still considered investigational, nor will they pay until specific payment codes (CPT codes) are developed for that procedure.
When will insurance pay?
We do not anticipate insurance companies to pay for stem cell procedures in the foreseeable future (e.g.. several years).
Will you submit a claim anyway for me?
Unfortunately, we already spend an inordinate amount of time and effort to obtain contractual payment from insurance companies for procedures that are covered and have learned that it is fruitless for us to pursue payment for non-covered procedures. Furthermore, it may be a violation of some of our insurance-provider contracts. You are welcome to contact your own insurer to determine your coverage and options.
How much pain is there at the harvest site afterwards?
Very little. Most patients report a bruised feeling for a few days that does not affect their activity or function. Most patients do not feel they have to take even over-the-counter medications for this discomfort.
What is the success rate?
The success rate varies widely depending on many factors – for example, your age, severity of joint problem, weight, and overall health. Generally speaking, on average, we are noting that 70-80% of our patients see meaningful improvements with the procedure.
How long do the benefits last?
We are hoping for a long term benefit. Because this is such a new procedure, there are very few studies with outcomes with the treatment of arthritis that have more than a 2 year follow-up. However, because we believe that we are fundamentally changing the diseased joint, we have good reason to believe the good results will last years beyond that. In the treatment of rotator cuff tears/repairs, we have an excellent study showing persistence of the stem cell treatment benefit 10 years after the initial procedure.
How long until I feel better?
This is highly variable depending on your diagnosis, recommended treatment, your overall health and fitness, activity level, age, and perhaps most importantly, whether you are having a surgical procedure along with the stem cell therapy. Please ask Dr. Farjo or his Physician Assistants regarding your specific case. We do note that patients will see improvements for up to 6 months to a year after a stem cell procedure. The initial recovery is related to the surgery, if any, that was performed. The later recovery is due to the actions of the stem cells.
Will I have to redo the procedure?
We do not routinely schedule repeat stem cell injections. However, if you received a partial response, or a good response that “wore off” over time, then we would consider a repeat treatment.
How often can I have it done?
At this point, there does not seem to be any benefit to treating the same joint any sooner than every 6 months.
STEM CELL BANKING:
What is stem cell banking?
Stem cell banking is storing your stem cells for future use. As you age, your stem cells decline in function and number – storing them while you are younger is essentially creating a “backup” of yourself at this point in time. Studies have shown that these cells, when frozen in the proper environment, can be thawed 25 years or more later and still function as well as the day they were frozen. This will give you the opportunity to use your younger, more vital stem cells, later in life when you need them more. Furthermore, it will allow you to utilize these more youthful cells in newer stem cell and regenerative medicine technologies that will become available in future years.
Can I bank my stem cells at the same time as my stem cell therapy procedure?
Yes. Dr. Farjo has partnered with Forever Labs (http://www.foreverlabs.co) to store your cells, if you so desire. He also serves as their Chief Medical Officer. There are additional costs for banking, that will be billed directly by Forever Labs. There is a discount if the banking is performed at the same time as a stem cell therapy procedure is being performed.
How do I arrange for stem cell banking?
Please go to the Forever Labs website at http://www.foreverlabs.co (note, it is .CO, not .COM), call them directly at (888) 344-8463, or email them at firstname.lastname@example.org.
Should I bank my stem cells if I am planning on using them for another procedure in the upcoming year?
No. The banking is a long-term storage option. Also, currently the FDA does not allow us to re-inject previously frozen stem cells for musculoskeletal problems. We anticipate that this will change in the future.
© Laith Farjo, M.D. and Advanced Orthopedic Specialists, P.C., 2016. No part of this document may be reproduced or published without our express written consent. All rights reserved.