What are stem cells?
A particular set of specialized cells that can transform into other types of cells, that can then regenerate and repair diseased or damaged tissues. These cells are also capable of replacing themselves, making them a renewable resource within the body. These cells are often referred to as “regenerative cells” because of their ability to regenerate tissues.

What are the two main types of stem cells?
Embryonic Stem Cells (ESC): These cells are harvested from the inner cell mass of a blastocyst (an early-stage embryo). Human embryos reach the blastocyst stage five to seven days after fertilization, at which time they consist of 50 to 150 cells. For safety reasons, this type of cell is not used, or even available, in the United States.

ESCs are the only cells that are omnipotent (the ability to become any, and all, types of cells). In other words, when given sufficient and necessary stimulation for a specific cell type, they can develop into each of the more than 200 cells types found in the adult body. With that said, they can also form tumor cells.

Sources of Embryonic Stem Cells: Embryos

Adult Stem Cells: All stem cells harvested after the first week of fertilization are considered adult stem cells. Even a newborn baby has adult stem cells. Adult stem cells are the only type of stem cells in use in the United States.

Adult stem cells produce the different kinds of cells that maintain the body’s tissues and organs, and more importantly, they have the ability to divide and reproduce indefinitely. These cells typically produce the types of tissue in which they are found (i.e. stem cells found in bone marrow want to become orthopedic tissues, such as bone and cartilage, more readily than stem cells found in fat/adipose tissue).

Sources of Adult Stem Cells: Sources of adult stem cells include, but are not limited to fat, bone marrow, blood, liver tissue, and brain tissue.

Why are stem cells important?
Stem cells play a critical role in tissue repair and regeneration. This is a natural process in the human body that science has simply made more efficient. When you sustain an injury, such as a broken bone, it is your stem cells that repair that injury.

Where are stem cells found?
Stems cells are found in various tissues/reservoirs throughout the body. Certain tissues are better reservoirs than others. A good reservoir is somewhere where the stem cells can be easily obtained. Bone marrow and fat are the best reservoirs in the body for stem cells. Cells from both bone marrow and fat can be obtained through a simple aspiration procedure.

What types of adult stem cells can be found in my bone marrow?
Mesenchymal Stem Cells: These cells are capable of transforming into cells that can form tissues such as bone, cartilage, fat, muscle, and other connective tissues.

Hematopoietic Stem Cells: These cells are capable of forming blood and immune type cells. In some instances, these cells are able to transform into the type of cells that form tissues such as bone.

Endothelial Stem Cells: These cells create the cells necessary to form networks of blood vessels to transport nutrients and waste to and from newly formed tissues.

Platelets: While these cells are not capable of forming tissues or tissue-forming cells, they are responsible for the signaling of the regenerative cells that can form such tissue-forming cells. For this reason, platelets play a critical role in tissue regeneration.

Other Supporting Cells: There are many other supporting cells present in bone marrow. All of the stem and supporting cells, in addition to the platelets, create a complex microenvironment and work in harmony to heal and regenerate injured tissues.

Why doesn’t my doctor use stem cells from my fat?
Available systems and devices for concentrating stem cells from fat are rather inexact at how they recapture stem cells from harvested fat. Cell analysis (cell counting and confirmation of cell viability) is not available for fat concentrate. Fat only contains one type of stem cell, and thus is a less complete graft type than marrow-derived cells. Additionally, most fat concentration systems do not meet the FDA’s requirements regarding minimal manipulation and biologics. Your doctor has taken great care to choose a system that adheres to all of the FDA’s requirements and allows for comprehensive cell analysis.

Why doesn’t my doctor use donor stem cells?
While donor stem cells may seem convenient, they have several problems associated with their use:
a) First, these cells do not meet the FDA requirements regarding minimal manipulation, thus the FDA believes that these cells should require further safety testing and perhaps be classified as a drug, which would make their testing for market more rigorous and thorough.
b) Questions have arisen regarding the safety of using donor stem cells. Some sources are concerned about the risk of rejection of these donor cells, much like rejection in organ and tissue transplantation.
c) Methods of sterile processing of donor stem cells significantly and negatively impact cell viability. Additionally, the FDA has recalled some varieties of donor stem cells because of their lack of sterility.
d) For some purposes, donor stem cell formulations from certain donor tissues (such as fat), have not been shown to regenerate tissue for certain purposes such as bone formation for fusion, which defeats the purpose entirely.

How do stem cells work?
Stem cells, especially in combination with platelets, can recognize tissue injury and have the ability to form tissue-forming cells that can regenerate tissues to heal the injury. Stem cells receive signals from other stem and supporting cells to direct what types of tissue they can form.

How does my doctor obtain my stem cells?
Your physician will obtain your adult stem cells through a simple bone marrow aspiration procedure. This procedure is simple and safe and typically takes between five and ten minutes. This small volume (≈2 fluid ounces) type of bone marrow aspiration is relatively painless and can be performed with just local anesthetic. Bone marrow aspiration does not weaken the patient’s bone or the immune system. Many patients do not have any discomfort at the aspiration site following the bone marrow aspiration procedure.

How does my doctor guide the aspiration and injection procedures?
Your physician will use ultrasound, X-ray, and/or CT scanning to guide the aspiration and injection procedures. Imaging guidance is important to ensure the exactness of the aspiration and injection procedures, and it also promotes the safety of this type of procedure.

What applications does my doctor use my stem cells for?
Your physician may use your adult stem cells in many ways. These cells are very versatile. Adult bone marrow derived stem cells are commonly used for the following applications:

  • Graft for Spine Fusion
  • Graft for Orthopedic Fusion
  • Injection Treatment for Nonunion
  • Injection Treatment for Avascular Necrosis
  • Injection to Augment Traditional Orthopedic Surgery
  • Injection Treatment of Degenerative Disc Disease
  • Injection Treatment of Mild to Moderate Orthopedic Injury

Why is it important to concentrate my bone marrow cells?
Literature and clinical practice have proven that cells must be concentrated to achieve a per ml cell load sufficient enough to achieve tissue regeneration. Before marrow is concentrated, it does not achieve this necessary minimum per ml cell load. Concentration is the only way to achieve cell concentrations high enough to induce meaningful tissue regeneration. Additionally, concentration of marrow is necessary to reduce marrow volume for clinical use.

What is removed when my bone marrow is concentrated?
Concentration removes anything that would otherwise dilute the stem cells and platelets. Platelet poor plasma, which is essentially water, is removed along with aged red blood cells. The resulting concentrate is a small volume that is rich in regenerative cells and platelets.

Why can’t my doctor just culture (grow in a lab) my cells?
Cell culture is not allowed in the United States due to FDA concerns about safety. FDA restrictions on minimal manipulation mandate that bone marrow and other adult stem cells must be processed and used during the same point of care procedure. These cells cannot be taken out of the patient’s procedure room, let alone cultured in a lab setting for a few hours, days, or even weeks. Additionally, harvested cells cannot be stored for a future procedure.

Why can’t my doctor just draw and concentrate my blood?
While blood does contain some stem cells, the concentration of those stem cells is quite low (3 million per ml) whereas bone marrow is significantly richer in stem cells (12-30 million per ml). It is important to capture these cells from a reservoir where they are most concentrated and then concentrate them even further using as specialized device. Additionally, the type of stem cells found in blood is different than the type of stem cells found in bone marrow. Most tissue-forming cells are found in the bone marrow, whereas the blood simply has blood- and immune-forming cells.

How long does a stem cell injection procedure take?
Most regenerative cell injection procedures take 30-45 minutes. Bone marrow aspiration takes five to ten minutes. Cell concentration takes about 15 minutes. Your doctor can prepare the injection site while the cells are being concentrated. Injection of your concentrated cells takes only a couple of minutes.

What is the recovery like following a stem cell injection?
Some patients experience a flare in their pain symptoms following a stem cell injection. This flare typically subsides in less than three days, is intermittent in nature, and can be easily treated with an ice pack and perhaps a low dose of pain medication. After the flare, if any, the patient’s pain returns to their baseline before the treatment. Patients should then experience a steady and significant decrease in their pain and disability during the next 12 weeks with the maximum improvement attained at six to 12 months post-procedure.

Will insurance cover a stem cell procedure?
Insurance will cover your use of your own stem cells when it is part of a procedure requiring graft (i.e. spine fusion, orthopedic fusion, treatment for avascular necrosis) and when the procedure is done at a hospital. Insurance does not yet cover regenerative cell injection procedures. Injection procedures are cash pay and are typically done at an outpatient facility such as a surgery center or in an advanced office setting. Alternatively, your insurance will most likely cover your initial exam and imaging studies used to define a stem cell injection as a viable option for treating your condition.

How much does a cash pay stem cell injection procedure cost?
Prices vary depending on where you live and what is being treated. Depending on procedures, insurance, and diagnoses, the cost can range from $1,000 to $5,000. Patients should also factor in the amount of downtime they should take following this procedure. In some cases, your doctor may prescribe a three-week period of bed rest following the procedure.

Will I ever need another stem cell injection treatment?
The notion that you will need a retreatment at some point in your lifetime is very likely. When that time is will vary from patient to patient. Retreatments prior to the six to 12 month mark are not recommended, as transplanted cells are still proliferative during that time. Nothing about this treatment stops the natural aging process of the transplanted cells nor the tissues into which they are injected. Additionally, nothing about this procedure prevents injury that can be sustained during accidents, whether recreational, vehicular, etc.

Does this procedure work for people with bone on bone osteoarthritis (OA)?
Those patients who have bone on bone OA are not likely to achieve as much improvement in their cartilage as patients who have less advanced OA. However, this procedure acts like a “surface paving” and has the potential to fill in cracks and other defects in the bone and remaining soft tissue, which can decrease the patient’s pain and disability from their disease, delaying their need for further interventions such as surgery, including total joint replacement.

How do the different cells in BMAC know what type of tissue to become? For example, how do the cells know not to make bone in the disc space?
These cells are very smart. They receive signals from the tissue cells around them and begin to build tissues to match. There are no literature references showing that adult autologous stem cells, especially those from bone marrow, form unintended tissues in their injection site.

When should a patient seek treatment using stem cells?
Simply, the sooner the better. This type of treatment is MOST effective for patients with mild to moderate degeneration. Patients with more severe degeneration have reported some significant improvements, but are unlikely to experience the degree of positive outcomes as patients with mild or moderate degeneration or injury. Lastly, this is an elective procedure. In no way is this procedure considered emergency treatment.

What is the best resource for finding a stem cell research study?
www.clinicaltrials.gov

Do I need a referral to see a Doctor about stem cell treatment?
This depends on your insurance; in many cases, the answer is no.

What are the best sources for finding GOOD literature about stem cell treatments?
Certainly check with your doctor first. He or she will have a supply of appropriate, accurate, and reputable papers. If you would like more literature, they can certainly contact the Director of Training & Development at Progenicare. If you still want to search for papers on your own, some reputable sites are listed below. Please note that not all papers are free.

www.pubmed.gov
www.scholar.google.com
www.thespinejournalonline.com
www.jbjs.org

Is the procedure painful?
Many patients report mild to moderate discomfort lasting less than five minutes during the aspiration portion of the procedure. Discomfort at the aspiration site subsides as soon as the aspiration procedure is complete. Most patients report mild discomfort at their injection site consistent with what they would feel after any routine shot or injection. Specific procedures, such as injections into the disc in the spine can cause intermittent increased discomfort that patients report as moderate and is well treated with an ice pack and/or oral pain medications. This discomfort typically lasts less than three days.

Is bone marrow aspiration painful?
Your physician has received specialty training in this small volume type of bone marrow aspiration. Most patients report mild to moderate pain lasting less than five minutes during the aspiration portion of the procedure. Most patients report that this pain is “manageable” and give it a rating of 3-5/10 on the typical 1-10 pain scale.

Is the stem cell injection procedure painful?
Most patient report relief of their painful symptoms following their procedure. Most patients report mild discomfort at their injection site consistent with what they would feel after any routine shot or injection. Specific procedures, such as injections into the disc in the spine, can cause intermittent increased discomfort that patients report as moderate and is well treated with an ice pack and/or oral pain medications. This discomfort typically lasts less than three days.

When should I expect to see improvement?
Most patients report some initial improvements in their pain within a few days of the procedure. Studies show that most patients experience a significant decrease in their pain and improvements in their disability within the first couple weeks and months following treatment. These improvements should continue through the six-month mark. Improvements in pain and disability happen as your adult regenerative cells begin to influence tissue healing at your injury site. Improvements are typically cumulative in nature. Improvements may be visible on MRI around the one-year mark.

How much will the procedure cost?
Procedure costs vary depending on what is being treated. Insurance may cover this type of treatment under some very specific circumstances. In most cases, this procedure is not yet covered by insurance. Please work with your physician regarding options for payment for this treatment.