Overview - Cell Therapy | Cellular Healing

Although they may be reported as a miracle cure, the truth is that they are not. Miracles can’t be explained by normal science, but stem cells can easily be explained. Stem cells are special and undifferentiated cells capable of forming new cells required to maintain the normal, healthy function of an organ or system of a living organism. Undifferentiated means these cells have not yet completed their growth into a mature cell with a specific function. Thus, these cells have great potential to morph and change to the immediate needs of the organism. Therefore, they are extraordinary and valuable, but not quite a miracle.

Stem Cells provide our bodies with the ability to develop, restore or regenerate cells in every organ and system in our body. There is a constant balance of death and regeneration of cells within our body and stem cells help keep that balance in favor of restoring and regenerating. Stem cells can change their development and adapt to the constantly changing needs of our bodies. They also help change the environment of the damaged area to conduct the beautiful symphony of the healing process within our bodies. Without stem cells, our organs, joints and physiologic systems would fail very rapidly.

Stem cells can come from other sources such as embryos, amniotic tissue, placental cord blood or cells from another person, but we will only discuss the use of cells taken from the same person to help heal their own body. These are called autologous adult stem cells. The word autologous means the cells come from within the same person (auto = same). These cells are by far the safest and most ethical form of stem cells for use in orthopedic conditions.

Although there are many different types of stem cells, the three type of stem cells within our own body used for common orthopedic conditions include:

Hematopoietic: from your blood.
Mesenchymal Stromal Cells: from your bone but also found in muscles and tendons.
Progenitor Cells: mature stem-like cells from your bone marrow.

Stem cells help conduct the normal, healthy healing process of our bodies. Many other treatments for degenerative diseases work by blocking a biologic pathway, but doing little to stimulate the healing pathway. Stem cells work on both parts of the problem. They help reduce the harmful chemicals in the diseased area, as well as helping cells to properly communicate with each other to mount a reparative response and to restore the normal balance of damage and repair¹. Unlike artificial chemicals or metal or plastic used to treat many degenerative processes, the use of autologous (your own) cells already found in your body means a treatment option which provides a natural restoration of the normal organ function².

There is a constant balancing act within our bodies occurring 24 hours a day. Every minute of the day, cells are dying or are damaged, and every minute, our wonderful bodies repair and/or replace these cells. This balance between constant damage/death and repair/replace within an organism is called homeostasis. However, in many orthopedic conditions, this delicate balance becomes upset, and we can start to experience small shifts or even more damage than what our bodies can repair. When this happens, we have developed a disease state known as a “degenerative disease” because our joints, tendons, bones, and muscles start to slowly breakdown or degenerate³.

One of the reasons why our body shifts from a healthy balance of to one of degeneration, is the fact that the number of stem cells in the specific area of disease slowly decreases over time. Mesenchymal stem cells normally used to help support our musculoskeletal system begin to decrease in numbers from our appendicular (long bones) skeletal system and shift to our central (broad bones) skeletal system. Research in the location and concentration of mesenchymal stem cells reveals that stem cells start to decrease in the bones furthest away from our central core such as our fingers and feet and continues to decrease as we age so by the time we are middle age, we have lost approximately 90% of the stem cells in the heel bone compared to our central pelvic bones⁴. This lack of stem cells allows the finite balance to be shifted towards damage, and the result is a slow, but persistent degenerative process. Stem cell therapy not only provides a source of new cells, but they also provide an optimal environment for cells to communicate with each other. Damaged cells have problems communicating with each other and stem cells help restore these normal lines of communication called paracrine signaling⁵. Stem cell therapy for orthopedics is directed towards restoring the deficiency of stem cells within the degenerative area, and it also helps to reduce the imbalance of harmful chemicals and restores the normal cell to cell communication process⁶. The best way to remember how stem cells work is to memorize, reduce, restore and regenerate. They reduce the bad chemical environment; restore normal cell to cell communication; and regenerate the normal balance of damage and repair.

We can think of stem cell therapy as redistribution of cells from areas of abundance to areas of deficiency. Stem cell therapy for orthopedics should also be thought of as a method of rescuing the degenerative area from a losing battle with mother nature and facilitating the normal, natural function of this area of the body. This theory does not claim that autologous stem cell therapy will regenerate a new joint, tendon, muscle or even a single hair. Rather, this theory promotes the hypothesis that autologous stem cell therapy can reduce the harmful effects of a destructive chemical environment; restore cell to cell communication; and regenerate the normal balance of damage and repair. Oddly enough, the regeneration of tissue has little connection to the relief of pain and the restoration of function⁷. New tissue can be regenerated with autologous stem cell therapy for orthopedics⁸, but the real benefits of this therapy lies in the restoration of the normal balance of damage and repair⁹. The ability of this therapy to accomplish these steps is not solely related to the stem cells found within the bone marrow, but it is the natural combination of important healing proteins and growth factors extracted from this bone marrow in the correct ratios and concentrations¹⁰.

The effect of the restoration of homeostasis (balance of damage and repair) through autologous stem cell therapy has long term effects lasting over 30 years in some studies¹¹. This is unlike any other treatment we have for common orthopedic condition. Because this is a natural treatment without the need for an artificial joint or harmful drugs, patients tend to prefer this treatment. In one study, 70% of the patients who received a stem cell therapy to one knee and a traditional knee replacement to the other knee, preferred the stem cell therapy knee over the replaced knee¹².

In summary, adult autologous bone marrow derived stem cell therapy for orthopedics helps correct a known deficiency in the degenerative area of your body and it also restores a natural balance of damage and repair so you can return to a lifestyle with less pain and more function with lower complication rates and higher patient satisfaction¹³.

There are two major reasons to use bone marrow as the source of stem cells:

This is the only source of stem cells allowed by the FDA
This is the most comprehensive stem cell treatment

The FDA ruled on the use of cell based therapies in November of 2017 and autologous bone marrow-derived stem cells were determined to be both homologous and minimally manipulated and thus allowed for use in conditions such as arthritis. Click here to read the FDA report. What this means in plain English is that the cells taken from your own bone marrow are safe because they are not changed or manipulated in a dangerous manner, and they are placed back into an environment which is like the place they were taken (homologous). Only bone marrow cells can lay this claim. Cells taken from fat or from other humans or placental tissue are deemed to be in violation of the FDA regulations. This is because they are manipulated and changed as well as being placed in an area where they are not naturally found in the human body.

The other reason why we use bone marrow cells is because it provides the complete package for restoring the normal balance between damage and repair. This is not just stem cells. Bone marrow provides important plasma proteins and growth factors. One of the most important components of the cell based therapy are the proteins which help prep the area for cell health. Bone marrow or plasma contains these important proteins which help reduce harmful chemicals and encourage cell growth. Bone marrow also contains many of the growth factors found in platelet rich plasma but in higher concentrations.¹⁴ These growth factors help fertilize the field so the native stem cells can function properly. Thus, bone marrow or platelet rich plasma therapy is the only compressive and legal cell therapy providing all the right stuff.

Before we talk about the actual results of these studies, we should discuss how the bone marrow derived stem cell therapy is produced. Although there are some wide variations on how this is produced, many follow the basic procedure of taking bone marrow from the pelvic bone using a special bone marrow needle called a Jamshidi needle. The technique used to harvest (remove) the bone marrow is important because there can be a 300% difference in the number of stem cell colonies based on how the bone marrow is removed¹⁵. Most of the time, the larger amounts of bone marrow are concentrated using a centrifuge (a device which spins at a fast rate) to separate the cells into specific layers. The layers align based on the specific gravity (weight) of each cell. Most, but not all, of the important stem cells, proteins and growth factors end up in the middle layer of this process called the “buffy coat.”. This rich layer is just like the juicy layer of a parfait and it is removed carefully. The red cells such as your hemoglobin which carry the oxygen throughout your body are the heaviest cells and they are the bottom layer. The lighter yellow layer is what was once known as the platelet poor plasma layer. This thinner, lighter platelet poor layer was thought to be worthless, and was discarded in the biohazard trash. However, recent research indicates that this layer can be concentrated into what is known as General Fluid Concentrate (GFC) with rich supplies of important proteins such as Interleukin 1- beta receptor antagonist or Alpha-2- Macroglobulin used to help damaged joints¹⁶. Sometimes, extra bone marrow is harvested in very small batches under high suction to provide a bone marrow aspirate to inject into the area of damage without processing. This process is allowed because the ratio of stem cells and proteins to red blood cells is favorable for growth and prevention of inflammation.

After the cells are harvested and/or processed properly, we can deliver these to the area of damage or degeneration usually within 30 to 40 minutes. In some cases, the injection is done under ultrasound or x-ray guidance. However, if the area is large enough and easy to reach with a normal needle, there is no need for ultrasound or x-ray.

Within 5-10 minutes after receiving the injected cells, you can get up and walk usually without any assistance and you can return to your work and normal activities the next day. Simple non-stressful exercises such as a stationary bike and walking are resumed in a few days.

In some cases, the bone marrow stem cells are delivered into specific areas of the bone on either side of the knee or into the knee cap. This is usually recommended if there are areas of acute bone marrow inflammation found during an MRI of the knee. If this is recommended, it is normally delivered under the comfort and control of a surgical suite setting. A special bone marrow needle is carefully introduced near the damaged or inflamed bone. The damaged bone marrow cells are removed by suction and the good cells are slowly infused into the bone. It is a simple “out with the bad and in with the good” concept. Sometimes, this is combined with an arthroscopic (tiny fiber optic camera) procedure within your joint to remove tears of the meniscus (cushion pad) or loose pieces of cartilage. In this case, you may be asked to use a walker or crutches for one week.

To see the entire process, watch the following video of the in-office procedure.

This is a question many patients ask and it is something we take very seriously. We try to reduce the discomfort of this procedure as much as possible and offer many different modalities and options. Personally, I have had this procedure done twice and can testify to the safety, comfort and efficacy of this treatment. Every patient has different pain thresholds and different concerns about a medical procedure. Thus, we offer a variety of options to experience this procedure. Most patients choose to have this done in our office under some oral sedatives, narcotics and a local anesthetic. Many have found this multimodal method of pain reduction to be very tolerable. However, if you would prefer to be unconscious for this procedure, this can be done under the care of a board-certified anesthesiologist at a local surgical center for a very reasonable extra cost.

With both procedures, most patients do not notice substantial improvement for approximately three (3) months. In our clinical experience, there is a progressive and step-wise reduction of pain and restoration of function. Every patient is unique and the recovery can vary. However, our clinical experience is that most patients start to notice improvement around the three (3) month period with progressive improvement at six (6) months and even more is seen at (12) months or longer. Peer reviewed research studies have shown that adult autologous bone marrow derived stem cell therapy has resulted in sustained relief for periods lasting over 12 years or more¹⁷.

Adult Autologous Bone Marrow Derived Stem Cell Therapy has been used for numerous orthopedic conditions in and around the knee with excellent safety and efficacy through peer reviewed published studies. We will review just a few of these studies and we will provide you with the references to these studies so you can read and evaluate them yourself. These studies are intended to provide you with a body of scientific knowledge since this is not generally accepted standard of treatment for most board certified orthopedic surgeons. You must consider that we are providing you with a one- sided review of these results. We do not provide you with studies that have a negative or neutral result. The reason is that we are not trying to hide information from the public, but rather to focus the review on the potential positive benefits of this therapy. In addition, new supporting and conflicting studies may appear daily, and we are only presenting from the body of literature at the time of the development of this web site. It is suggested you may want to perform your own review of the scientific literature. Click here to visit Published Medical Central, a website used by most researchers and physicians. Simply type the desired keyword in the search bar to read over 28 million citations from the Medline database. This way, you keep all of us honest in our review.

For discussions on studies on the use of cell therapy for specific conditions click on the following:

We should not discuss a procedure unless we have evidence that the treatment has far greater benefits than the potential risks. This follows the principle of “do no harm.” Luckily, bone marrow concentrate and stem cells coming from the same patient without any manipulation has a very good safety record. A large study called the Safe Cell study evaluated numerous stem cell studies with over 1012 patients treated for a variety of serious medical conditions and concluded: “Based on the current clinical trials, MSC appears safe.”¹⁸ Phillipe Hernigou from the University of Paris has been using bone marrow derived stem cell treatments for orthopedic conditions for over 30 years and followed over 1873 patients for an average of 12.5 years with over 7,306 MRI’s and 54,430 x-rays and no tumor formation was found¹⁹.

We will try to find the best treatment option for your specific condition and situation. Our goal is to ensure you receive this optimal option because nobody benefits when every patient is offered the same treatment. We normally customize our treatment options for each patient based on their specific needs. We call this CTC (Customized Treatment Combinations) and you can visit our CTC webpage to see just a few examples of these options. If we believe you will not benefit from cell based therapy, we will be honest and tell you right away. Our goal is to only recommend a treatment which we feel will meet your goals and desires. Nobody benefits when a treatment is not meeting your goals and desires.

Although this is not a complete list, it is a general guideline to help you understand whom may be the ideal candidate for this procedure. You and your surgeon will always find exceptions since not every patient responds the same to each treatment. Our goal is to recommend the best form or treatment for you based on numerous factors. Here are some factors we evaluate to find the best treatment for your specific and special condition:

Stable joint without frequent giving away or locking. If your joint feels unstable or gives away or locks more than two (2) times per week, you may require an additional procedure such as an arthroscopic procedure to fix a tear or remove loose cartilage and the stem cell therapy can be performed at the same time.
Lack of severe bowing of the joint. This normally means less than 10 degrees of bowing in either direction. Cell based therapies do not correct structural deformities and when the joint becomes so deformed that it impairs its normal function, cell-based therapy may not be your best solution.
Lack of frequent severe joint swelling requiring needle aspirations. If you have water removed from your joint more than four (4) times per year, stem cell therapy may not be recommended. Frequent and severe swelling of the joint may indicate that the cell based therapy may not be able to reduce this inflammation enough to provide substantial and long lasting relief.
Lack of severe stiffness of the joint. If your joint has lost more than 20 degrees of normal motion, you may not be a stem cell candidate. Normal healing of a joint requires close to normal range of motion. Joint fluid requires this range of motion to circulate within the joint and if this circulation is severely impaired, cell-based therapy may not be your best option.
Willing to participate in additional therapies to improve the health of the joint. Stem cell therapy has a higher rate of success when patients participate in frequent, simple, home based therapy exercises; help reduce their weight; and adapt healthy diets.

Although there is substantial evidence that Bone Marrow Derived Stem Cell Therapy is safe and effective, there is not a Medicare procedure code for this treatment. Thus, no standard insurance carrier covers this procedure because they require a procedure code. Even if you have very expensive insurance policy just like our congressmen, there is no way to bill standard insurance for the harvesting, processing and delivery of these cells because there is no accepted code for this procedure. Other surgeries used to treat the knee, such as arthroscopic meniscal removal or loose body removal, are covered benefits because they have a standard accepted procedure code. However, cell-based therapies are not. If you have a health sharing plan such as Medi-share™, stem cell therapy may be covered since the cost of this procedure is much lower than a joint replacement. Most health sharing plans are affiliated with a religious organization and you must choose this rather than Affordable Care Act (ACA) sanctioned plan. Also, if you have a health spending account, the expenses associated with this procedure may be offset by these accounts. We are constantly looking for methods to reduce the cost while improving the outcomes of this procedure and overall, our costs have been reduced substantially over the past few years. We also realize that not all patients are the same, and some may be able to benefit from lower cost harvesting and processing devices. Furthermore, some patients are requesting comprehensive treatment packages including exercise, nutrition and adjunctive health promoting therapies. Thus, we offer a wide variety of options to fit every patient’s arthritic condition and desires for additional, adjunctive proven therapies. We can review these options with you one-on-one to find the best fit based on your condition and desires. However, we have very effective bone marrow stem cell therapies starting around $2,950. If you would like to learn more about these plans, please review our patient services in the website menu or contact us for an immediate consultation.

¹ THE MSC: AN INJURY DRUGSTORE. CAPLAN AI, CORREA D.Cell stem cell. 2011 Jul 8; 9(1): 11-15 PMC [article] PMCID:PMC3144500 PMID: 21726829 DOI: 10.1016/j.stem.2011.06.008

² MSCs: The Sentinel and Safe-Guards of Injury. Caplan AI. J Cell Physiol. 2016 Jul;231(7):1413-6. doi: 10.1002/jcp.25255. Epub 2015 Nov 26. Review. PubMed [citation]PMID: 26565391

³ Homeostatic Mechanisms in Articular Cartilage and Role of Inflammation in Osteoarthritis. Houard X, Goldring MB, Berenbaum F. Current rheumatology reports. 2013 Nov; 15(11): 375 PMC [article] PMCID: PMC3989071 PMID:24072604 DOI:10.1007/s11926-013-0375-6

⁴ Reduced levels of mesenchymal stem cells at the tendon-bone interface tuberosity in patients with symptomatic rotator cuff tear. Hernigou P, Merouse G, Duffiet P, Chevalier N, Rouard H. Int Orthop. 2015 Jun;39(6):1219-25. doi: 10.1007/s00264-015-2724-8. Epub 2015 Mar 12. PubMed [citation]PMID:25757411.

⁵ Paracrine mechanisms of mesenchymal stem cell-based therapy: current status and perspectives. Liang X, Ding Y, Zhang Y, Tse HF, Lian Q. Cell Transplant. 2014;23(9):1045-59. doi: 10.3727/096368913X667709. Review. PubMed [citation] PMID:23676629

⁶ Mesenchymal Stem Cells: Time to Change the Name! Caplan AI. Stem Cells Transl Med. 2017 Jun;6(6):1445-1451. doi: 10.1002/sctm.17-0051. Epub 2017 Apr 28. PubMed [citation]PMID:28452204 PMCID: PMC5689741)

⁷ Long-term outcomes after first-generation autologous chondrocyte implantation for cartilage defects of the knee. Niemeyer P, Porichis S, Steinwachs M, Erggelet C, Kreuz PC, Schmal H, Uhl M, Ghanem N, Südkamp NP, Salzmann G. Am J Sports Med. 2014 Jan;42(1):150-7. doi: 10.1177/0363546513506593. Epub 2013 Oct 21.PubMed [citation] PMID:24145948

⁸ Subchondral stem cell therapy versus contralateral total knee arthroplasty for osteoarthritis following secondary osteonecrosis of the knee. Hernigou P, Auregan JC, Dubory A, Flouzat-Lachaniette CH, Chevallier N, Rouard H. Int Orthop. 2018 Mar 27. doi: 10.1007/s00264-018-3916-9. PMID: 29589086

⁹ Mesenchymal Stem Cells: Time to Change the Name! Caplan AI. Stem Cells Transl Med. 2017 Jun;6(6):1445-1451. doi: 10.1002/sctm.17-0051. Epub 2017 Apr 28. PubMed [citation] PMID: 28452204 PMCID: PMC5689741)

¹⁰ Inflammatory licensed equine MSCs are chondroprotective and exhibit enhanced immunomodulation in an inflammatory environment. Cassano JM, Schnabel LV, Goodale MB, Fortier LA. Stem Cell Research & Therapy. 2018 Apr 3; 9: 8 PMC [article] PMCID:PMC5883371PMID:29615127 DOI:0.1186/s13287-018-0840-2

¹¹ Osteonecrosis repair with bone marrow cell therapies: state of the clinical art. Hernigou P, Flouzat-Lachaniette CH, Delambre J, Poignard A, Allain J, Chevallier N, Rouard H. Bone. 2015 Jan;70:102-9. doi: 10.1016/j.bone.2014.04.034. Epub 2014 Jul 10. Review.PMID:25016964.)

¹² Subchondral stem cell therapy versus contralateral total knee arthroplasty for osteoarthritis following secondary osteonecrosis of the knee. Hernigou P, Auregan JC, Dubory A, Flouzat-Lachaniette CH, Chevallier N, Rouard H. Int Orthop. 2018 Mar 27. doi: 10.1007/s00264-018-3916-9. PubMed [citation] PMID: 29589086

¹³ Subchondral stem cell therapy versus contralateral total knee arthroplasty for osteoarthritis following secondary osteonecrosis of the knee. Hernigou P, Auregan JC, Dubory A, Flouzat-Lachaniette CH, Chevallier N, Rouard H. Int Orthop. 2018 Mar 27. doi: 10.1007/s00264-018-3916-9. [Epub ahead of print] PubMed [citation] PMID: 29589086

¹⁴ Bone marrow concentrate and platelet-rich plasma differ in cell distribution and interleukin 1 receptor antagonist protein concentration. Cassano JM, Kennedy JG, Ross KA, Fraser EJ, Goodale MB, Fortier LA.Knee Surg Sports Traumatol Arthrosc. 2018 Jan;26(1):333-342. doi: 10.1007/s00167-016-3981-9. Epub 2016 Feb 1.PubMed [citation] PMID:26831858

¹⁵ Benefits of small volume and small syringe for bone marrow aspirations of mesenchymal stem cells. Hernigou P, Homma Y, Flouzat Lachaniette CH, Poignard A, Allain J, Chevallier N, Rouard H. Int Orthop. 2013 Nov;37(11):2279-87. doi: 10.1007/s00264-013-2017-z. Epub 2013 Jul 24.PubMed [citation] PMID: 23881064 PMCID: PMC382489.

¹⁶ Autologous conditioned serum for the treatment of osteoarthritis and other possible applications in musculoskeletal disorders. Frizziero A, Giannotti E, Oliva F, Masiero S, Maffulli N. Br Med Bull. 2013;105:169-84. doi: 10.1093/bmb/lds016. Epub 2012 Jul 4. Review. PubMed [citation]PMID:22763153

¹⁷ Subchondral stem cell therapy versus contralateral total knee arthroplasty for osteoarthritis following secondary osteonecrosis of the knee. Hernigou P, Auregan JC, Dubory A, Flouzat-Lachaniette CH, Chevallier N, Rouard H. Int Orthop. 2018 Mar 27. doi: 10.1007/s00264-018-3916-9. [Epub ahead of print] PubMed [citation] PMID: 29589086)

¹⁸ Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell): A Systematic Review and Meta-Analysis of Clinical Trials. Lalu MM, McIntyre L, Pugliese C, Fergusson D, Winston BW, Marshall JC, Granton J, Stewart DJ, Canadian Critical Care Trials Group. PLoS ONE. 2012 Oct 25; 7(10): e47559 PMC [article] PMCID: PMC3485008 PMID: 23133515 DOI: 10.1371/journal.pone.0047559)

¹⁹ Cancer risk is not increased in patients treated for orthopaedic diseases with autologous bone marrow cell concentrate. Hernigou P, Homma Y, Flouzat-Lachaniette CH, Poignard A, Chevallier N, Rouard H. J Bone Joint Surg Am. 2013 Dec 18;95(24):2215-21. doi: 10.2106/JBJS.M.00261. PubMed [citation] PMID:24352775.

Stem Cell Therapy Overview

Stem Cell Therapy by Cellular Healing

What are stem cells?

Why use stem cells?

Why use bone marrow?

How do you get the cells?

How are the cells delivered?

How much pain would I experience?

How long before I notice any improvement?

Is there evidence that this works?

Is bone marrow safe?

Who is a candidate for stem cell therapy?

How much does this cost?

Footnotes

What Are Stem Cells?

Why Use Stem Cells?

Why Use Bone marrow?

How Do You Get The Cells?

How Are The Cells Delivered?

How Much Pain Would I experience?

How Long Before I Notice Any Improvement?

Is There Evidence That This Works?

Is Bone Marrow Safe?

Who Is A Candidate For Stem Cell Therapy?

How Much Does This Cost?

Footnotes

READY FOR HEALING?