Orthobiologics are healing elements that your physician may use to help injuries heal more quickly and more completely. They are used to improve the healing of bones, muscles, tendons, discs and ligaments. These products are made from substances that are found naturally in your body.
Examples of commonly used Orthobiologics includes:
Cells (e.g. stem cells, platelets, immune system cells, progenitor cells, and pericytes)
Molecules (e.g. growth factors, cytokines, chemokines, enzyme inhibitors, proteins, and exosomes)
Regenerative Medicine is a new field of medicine devoted to fully healing damaged tissues by using cells and cellular molecules. It offers hope for people with conditions that previously could only be managed with medication or surgery. It is based on an understanding of the body’s ability to heal itself naturally. Regenerative Medicine physicians utilize this knowledge to offer new treatment options. Clinical trials are ongoing and have helped physicians to inform and treat their patients. The field of Regenerative Medicine is growing exponentially and promises exciting discoveries and life changing possibilities.
Physical Medicine and Rehabilitation (PM&R) physicians, also known as a physiatrist (pronounced, “FIZZ-EYE-A-TRIST), treat a wide variety of orthopedic conditions affecting the joints, discs, ligaments, muscles, nerves and tendons. PM&R physicians are medical doctors who have completed residency training in the specialty of Physical Medicine and Rehabilitation. They are certified by the American Academy of Physical Medicine and Rehabilitation (AAPMR).
PM&R physicians tend to focus treatment on physical function. They have a broad medical expertise, diagnose and treat pain, lead a treatment team, and treat the whole person, not just the painful area.
Most orthopedic injuries can be treated without surgery. Physical Medicine and Rehabilitiation (PM&R) physicians are ideally suited to manage these conditions. They are specialists in the field of physical medicine, physical therapy, interventional spine care, rehabilitation, pain management, diagnostic musculoskeletal imaging, sports medicine and regenerative medicine.
PM&R physicians are expert diagnosticians and have advanced spine, joint and tendon treatment skills. They are able to design comprehensive treatment plans and fully understand the pros and cons of all treatment options.
Physicians who offer “stem cell therapy” without specializing in physical medicine or orthopedics deprive their patients from an accurate diagnosis and they may not have a full understanding of the conventional and complementary treatment options available to their patients.
We treat many sources of musculoskeletal pain including tendon tears, ligament strains, degenerated lumbar intervertebral discs, and degenerated joints. We also treat inflammed tissues such as synovial joints and peripheral nerves. Often times the body will not spontaneously heal these damaged tissues.
Tendons, cartilage and discs have relatively decreased circulation and may not heal completely when injured. Excessive joint inflammation may lead to pain and cartilage degeneration. Insufficient inflammation due to steroid or NSAID use may lead to incomplete tendon healing. Chronically tightened muscles may signify chronic ligament or joint capsule laxity leading to osteoarthritis. Some patients have had repeated injuries or surgery and are left with unhealed tendons or ligaments. We have had success treating all of these conditions.
Our patients often have musculoskeletal conditions that have not responded to conventional medical care. In other cases, patients are hoping to avoid a painful or risky surgery. And many people are looking at treatments that facilitate natural healing, promote quick recovery and minimal down time. This is especially true of our professional athletes who depend on their bodies to make their living.
If you had asked me this question just after I completed my residency training in 1997, I would have said “no”. At that time, the medical community believed that regeneration of these tissues was just not possible. Due to a relatively low cell count and poor circulation these tissues degenerate quickly and heal slowly, if at all. It is difficult to imagine that it would be possible to regenerate them. Even today you will encounter physicians who do not believe that it’s true, but it IS true!
Actually, tissue regeneration is not a new concept. Blood, which is a form of connective tissue, was first regenerated in 1956 when Dr. E. Donnall Thomas of Cooperstown, New York treated leukemia patients with bone marrow transplantation. Early in his career he was mocked by his peers and discouraged from completing his research. He would later receive the Nobel Prize in medicine along with Dr. Joseph E. Murray for pioneering work. Their efforts have saved the lives of thousands of adults and children.
It wasn’t until the 1980’s that scientists discovered and isolated the first human blood stem cells (hematopoietic stem cells). These are the cells responsible for the success of bone marrow transplants. Since then, many other types of stem cells, progenitor cells and pericytes have been discovered to play a significant role in the regeneration of human tissues.
I was first introduced to the possibility of tendon regeneration in 2006, when I read an article by Dr. Alan Mishra who was using blood platelets to treat patients with tennis elbow. His success with platelet rich plasma (PRP) encouraged me to use it in my own patients. I chose to treat patients who had not healed after months of medical care and were considering surgery for their pain. When I saw the positive results in my own patients, I knew immediately that orthobiologics would be the future of orthopedic care.
I have treated hundreds of patients with tendon, joint and spine injuries using innovative orthobiologics. Most of the time, these are people who have been suffering with pain for months or years. They have not responded to excellent traditional nonsurgical care. In some cases, patients have come to me after having had surgery that did not relieve their pain.
I have been tracking our clinical outcomes for several years and can report that 75-92% of our patients successfully respond to orthobiologic therapy, depending upon the medical condition that we are treating.
Stem cells are unique from other cells in the body in that they have the capacity to self renew and transform (differentiate) into another type of cell. These cells have the potential to create all the cells in every organ of your body.
The adult human body consists of more than 37 trillion cells with more than 220 different cell types. Each cell has a defined life span. Platelets live for only one week, whereas red blood cells live for about 4 months. Bone and muscle cells live about 25 years, and brain cells can live for your entire lifetime. Because your cells can become damaged or diseased they must be continually renewed. Stem cells are the source of these new cells. Physicians will use stem cells for the treatment of a host of difficult to treat medical conditions such as arthritis, diabetes and retinal blindness.
Adult mesenchymal stem cells (MSC) are different from embryonic stem cells, because they are more limited in their capacity to differentiate. They have been found in virtually every part of the body. But they can only differentiate into bone, cartilage, fat, tendon, liver, nerve or muscle cells. Molecules released from injured tissues stimulates these cells to transform into different cells types. The environment of tissue damage influences which types of cells need to be formed.
Embryonic stem cells exist during the first few days of embryonic development, however when grown in the lab they are immortal and can grow indefinitely. Embryonic stem cells have the capacity to become every type of cell in the body. Although used extensively in basic science research, the use of embryonic stem cells in medicine is prohibited. We do NOT use embryonic stem cells in our clinic.
Stem cells have been identified in the placenta, umbilical cord and amniotic fluid of newborns, but they more closely resemble adult stem cells because they can only become a limited number of different cell types. The Food and Drug Administration (FDA) does not permit the use of fetal tissue cells in patients at this time. Furthermore, the amniotic fluid products used do not contain viable stem cells as they are killed in the sterilization process. We do NOT use fetal tissue or amniotic fluid stem cells in our clinic.
The term “stem cell” first appears in the scientific literature in 1868 in the works of the German biologist and artist Ernst Haeckel. Haeckel, a major supporter of Darwin’s theory of evolution, mapped a genealogical tree relating all animal life to represent the evolution of organisms by descent from common ancestors. He called these trees “Stammbäume” which is the German word for family trees or “stem trees”. Haeckel used the term “Stammzelle”, which is German for stem cell, to describe the unicellular organism from which he believed all multicellular organisms evolved.
(Ramalho-Santos, “On the Origin of the term Stem Cell”; Stem Cell, Volume 1, Issue 1, June 2007).
In the early 1960s, James Till and Ernest McCulloch began analyzing the bone marrow of mice to find out which components were responsible for regenerating blood. They were the first to describe a method for detecting and counting pluripotent stem cells which is based on the ability of such stem cells to multiply and differentiate to form localized colonies in the spleen.
In doing so, they defined what remain as the two hallmarks of a hematopoietic stem cell (HSC): it can renew itself and it can produce cells that give rise to all the different types of blood cells. In 1963, they collaborated with molecular biologist Lou Siminovitch, and obtained the evidence that these same marrow cells were capable of self-renewal.
E. Donnall Thomas MD performed the first successful bone marrow transplantation for the treatment of leukemia using healthy bone marrow from an identical twin in Cooperstown, New York. In 1957, Dr. Thomas’ paper on bone marrow transplantation was published in The New England Journal of Medicine. It would take almost 20 years later for the procedure to become an accepted therapy. During that time most medical professionals dismissed the idea. According to Dr. Thomas, “in the 1960s in particular and even into the 1970s, there were very responsible physicians who said this would never work”. In 1990, he and Dr. Joseph Murray would receive the Nobel Prize in Physiology or Medicine for their discoveries in organ and cell transplantation in the treatment of human disease.
Today, the bone marrow transplant procedure that they developed are a proven success for treating leukemia and other cancers. Dr. Thomas is responsible for saving the lives of hundreds of thousands of people around the world. His groundbreaking work is among the great medical success stories in the treatment of cancer. Bone marrow transplantations have had worldwide impact, boosting survival rates from nearly zero to up to 90 percent for some blood cancers. Approximately 60,000 bone marrow transplants are performed worldwide each year.
The first human embryonic stem cell would not be discovered until 1998 when James Thompson from the University of Wisconsin successfully isolated and grew pluripotent stem cells from the inner cell mass of early human embryos that had been created in the lab using in vitro fertilization techniques.
In 2002, Jong-Hoon Kim and Jonathan Auerbach demonstrated that embryonic stem cells can generate neurons in a mouse that have the capacity to produce dopamine, grow axons and form functional synapses with the brain. This work reaffirmed the promise that stem cells play a role in Regenerative Medicine for treatment of Parkinson’s disease.
Our understanding of what stem cells are and how they function has been increasing almost daily ever since.
Dr. Arnold Caplan at Case Western Reserve University was the first to observe that certain kinds of cells could differentiate into cartilage, tendon or bone. He coined the term, mesenchymal stem cells (MSC) to describe their potential to repair skeletal tissues. For years, scientists believed that this process also occurred in the human body, and indeed it does.
However, now there is mounting evidence that MSCs have a more important role. They communicate with neighboring cells by secreting proteins that modulate cellular activity. These “paracrine” effects influence local cells to awaken from senesence, proliferate and differentiate into other cell types. The cells are reprogrammed to produce proteoglycans, collagen and other cell proteins essential for healthy tissue function. These cells stimulate the formation of new blood vessels and modulate inflammation in the body. All of these effects account for the healing effects that have been observed.
This issue has not yet been resolved. Every tissue in your body, including your brain has stem cells which have the capacity to generate new cells. And every blood vessel in your body is surrounded by pericyte cells which can induce other cells to multiply and differentiate into new cell types. Each cell has the capacity to secrete a host of different proteins (secretome) that can influence healing. And each cell behaves differently when placed in different tissues (cell niches).
Adipose (fat) tissue is easy to obtain from a patient and contains more mesenchymal stem cells than most other tissues. The number of cells will decline with age, but less so than that of bone marrow. This may benefit patients who suffer from inflammatory conditions such as knee osteoarthritis. It is easy to harvest adipose stem cells with a minor lipoaspiration procedure, which is even more simple than liposuction.
However, bone marrow contains hematopoeitic stem cells and immune cells not found in adipose tissue. These cells may be more beneficial for the treatment of tendon, bone or disc injuries. Your physician can determine which treatment options are most likely to help you with your specific condition.
Currently there are no FDA approved treatments that would involve implanting one person’s stem cells into another person. In the future, this is sure to change as my last search on ClinicalTrials.gov produced more than 1600 ongoing studies.
Any company striving to provide “stem cells in a bottle” would need to demonstrate safety and efficacy. This has not yet occurred. Embryonic stem cells provide even further difficulties in that they may form tumors or induce an immune reaction in the patient.
At San Diego Orthobiologics Medical Group we only provide treatments that use your own stem cells. This form of therapy is termed “autologous” stem cell therapy. We do not use embryonic stem cells and we do not use other people’s stem cells.
There is evidence that stem cell therapy is safe. A recent study followed more than 2,300 people who had received bone marrow stem cell therapy with an average followup time of 2.2 years. Adverse events such as procedure discomfort (less than 3%) and vascular or nerve injury (0.6%) were the most commonly cited events. These events were attributed to the actual procedure and not the stem cells.
The annual cancer rate for these patients was 0.14% which is lower than the adult national average according to the National Cancer Institute (0.78% for adults). These new cancers were unrelated to the procedure as none of these occured at the site where stem cells had been administered. In addition, more adverse effects were noted in patients who had received “culture expanded” stem cells. In these cases, cells were harvested from bone marrow, then grown in culture for up to 16 days before reinjecting them into the patient. This technique is no longer permitted in the United States as the FDA considers this method to exceed the “minimal manipulation” regulatory guidelines.
Unlike embryonic stem cells, adult stem cells have a more limited potential to transform into other cell types. For this reason, it is believed that adult mesenchymal stem cells (MCS) and hematopoetic stem cells (HSC) are unlikely to differentiate into a cancer cell.
There has not been a single reported case of new cancer attributed to adult stem cell therapy.
The safety of the procedure rests primarily in the hands of the physician who performs the procedure, not the cells that are injected. Physicians can obtain advanced training in fluoroscopic (xray) or ultrasound guidance to facilitate treatment comfort and safety.
In 1997, Dr. Rogers received advanced fellowship training in fluoroscopic guided injections. He is also certified in Musculoskeletal Sonography, which he has used for more than 14 years. He has performed tens of thousands of injection procedures and has trained hundreds of physicians in these procedures as well. He has never had a complication with any treatment and most of his patients report comfort with the medical procedures he has performed.
The United States, European, Japanese and other goverments have issued guidelines to regulate cellular and gene therapy. The United States Food and Drug Administration (FDA) has published guidance documents since 2007. These guidelines clearly state that therapies must comply with the “minimal manipulation” and “homologous use” stipulations.
Therapies that use enzymes to digest fat tissue (such as collagenase) do not comply with these guidelines and are prohibited.
This year, the FDA has taken action against medical clinics that are in not in compliance with these guidelines. Some physicians have established clinics in other countries in order to avoid the FDA restrictions. Patients must consider the motives of these physicians carefully.
The evidence for the effectiveness of stem cell and platelet rich plasma (PRP) therapies is growing exponentially. Prospective and randomized, Level I trials have now been completed for many applications of PRP for the treatment of tendon, joint and disc injuries. However, the evidence for adipose (fat) and bone marrow derived adult stem cell therapies is more limited.
One recent study observed more than 1,100 patients who received adipose tissue derived adult stem cells for the treatment of knee osteoarthritis. More than 91% of the patients obtained at least 50% improvement in pain and function when evaluated 12 months later.
In the patients we have treated at San Diego Orthobiologics Medical Group, we have recorded better clinical outcomes than this study. This may be due to the fact that we have very strict inclusion criteria. We only offer treatment to patients who have a high probability of success. Also, we combine these with therapies that enhance nutrition, circulation, mobility and strength.
Bone marrow derived stem cells treatment research studies of arthritis or tendon injury have demonstrated favorable responses as well, however none of the studies meet the criteria for a Level I study. Most studies are clinical case series or retrospective studies. Furthermore, each study used different methods of treatment making it difficult to make an absolute determination. However, each of these procedures are demonstrating good efficacy in many people who have not responded to other forms of therapy. Only further research will allow us to determine which methods of treatment are most effective for orthopaedic conditions.
Most of our patients will only need one treatment. In more challenging cases, repeat treatment may be required.
Yes, we do. We have treated people from almost every sport or profession. We also treat amateur athletes, former olympians, weekend warriors and just plain active people.
We do offer phone consultations for patients living outside of Southern California. However, a phone conversation does not constitute a complete medical evaluation. All of our patients receive a comprehensive medical history, physical examination and personal consultation to review diagnostic tests in order to develop a customized treatment plan. This is the standard of excellent care at the San Diego Orthobiologics Medical Group. Taking short cuts would lead to an incorrect or incomplete diagnosis and inappropriate treatment.
Some medical clinics invite you to forward your MRI report so that they may determine if you are a candidate for therapy. This is the absolute minimum information a physician needs to make an accurate diagnosis. It would be like an auto mechanic asking you to send a picture of your car. It’s just not enough information. The mechanic would need to look under the hood and perform further diagnostics.
Magnetic resonance imaging (MRI) has advanced medical care in countless ways. We use MRI on a daily basis to assist in our decision making. However, several studies have validated the limitations of MRI. An MRI does not always indicate where your pain is coming from. It tells you nothing about strength, mobility, muscle balance, sensation, circulation or dynamic motion. It does not look at the entire person, it is just one piece of information and it does not replace a complete medical evaluation. Physicians who are willing to treat you based solely on MRI findings risk exposing you to an unecessary procedure.
We have seen many patients who after being unsuccessfully treated at another medical group eventually find us. In many cases, they have been incorrectly diagnosed. This is particularly true in patients with lumbar spine pain where diagnostic accuracy is very difficult. I have treated people with spine injuries for almost 25 years. I was fortunate to receive outstanding mentorship from Dr. Paul Dreyfuss and Dr. Kevin Pauza during my fellowship in 1997. They are pioneers in the field of nonsurgical spine care. I’ve also had the opportunity to learn from countless excellent physicians, surgeons and cellular biologists. All have contributed to my education and training over the years.
In 2004, I was one of the first physicians to introduce diagnostic musculoskeletal ultrasound to San Diego. Diagnostic ultrasound offers many advantages over conventional x-ray and MRI. In the case of rotator cuff and other tendon tears, it has proven to be the imaging modality of choice. I have used diagnostic ultrasound to uncover hundreds of previously undiagnosed conditions for my patient’s benefit.
Ultrasound also allows me to perform orthobiologics therapy with high precision and comfort. Many patients are pleasantly surprised that my treatments are much less painful than those given by other physicians. Studies indicate that ultrasound guided therapies are more accurate than non-image guided injections.
Not all physicians are equally talented in the use of ultrasound. Although not difficult, years of training are required to become a proficient diagnostician. I’ve had the opportunity to attend and teach dozens of ultrasound training courses over the last thirteen years. I’ve completed thousands of examinations and thousands of treatments using musculoskeletal ultrasound. I am a certified Musculoskeletal Sonography physician (RMSK) which demonstrates my committment to learning this skill.
Some physicians believe they can inject a joint, such as the knee, without ultrasound or some other form of image guidance. They are not aware of the many research studies that proves physicians are 30 to 50% less accurate when they do not know how to use ultrasound. It is unlikely that treatment will be effective if the physician does not inject the orthobiologics into the correct location.
Another form of image guided injection therapy includes the use of digital x-ray, also called fluoroscopy. It is the standard of care for the treatment of spine injuries. I have used fluoroscopy for the treatment of spine and joint injuries for more than 20 years. I’ve treated tens of thousands of San Diegans who now refer their family and friends for treatment.
Accurate diagnosis and expert technical skill are required for successful administration of orthobiologics. However, once you regenerate an injured tissue, the job is not yet complete. Many people have concurrent stiffness, weakness or deconditioning as a result of their injury. Rehabilitation is necessary in order to prevent a reinjury from occurring. Solid scientific evidence proves that full tissue recovery requires stretching, strengthening and aerobic conditioning.
We will work closely with your wellness provider, whether they are a physical therapist, chiropractor, massage therapist, fitness instructor or other provider to make certain that you are restored to complete health. Most patients want to know what activities they can or can not do after treatment. The San Diego Orthobiologics Medical Group has developed Regenerative Medicine Rehabilitation Protocols that are customized to your specific needs.
I have been treating sports medicine injuries since 1984, when I was a UCLA athletic trainer. Since then, I have learned that patients with chronic tendon, joint or spine injuries are more complex than a simple ankle sprain.
The body has a remarkable capacity to repair itself. But, there are often co-existing issues that can prevent full recovery. The MyBioProfile Exam was developed to identify such issues as joint instability, limited joint motion, tissue inflammation, poor circulation or nutrition or other concurrent conditions. Our results are superior when we address these all of these issues.
The MyBioProfileTM Exam is a comprehensive evaluation that addresses four key areas to optimize results: Bioimaging, Biomechanics, Bionutrients, and Personal goals.
Bioimaging: These evaluations include a review of standard medical imaging such as radiographs and MRI, but also includes a dynamic ultrasound evaluation. Dynamic ultrasound evaluates tissues in real time. When necessary further imaging modalities are used to fully describe the tissue pathology.
Biomechanics: This evaluation includes a full body motion, balance, strength and stability screen. We perform a Functional Movement Assessment using advanced technology in our state-of-the-art gym. In select cases, gait and balance analysis will be included.
Bionutrients: This evaluation includes a review of nutrition, circulation, medications, supplements and coexisting medical conditions that influence the musculoskeletal system. Biomarkers are used to objectively measure the amount of inflammation in your body. Biomarkers have been shown in clinical trials to be better predictors of pain than xray or MRI.
Personal goals: Your personal goals are important to us. They are how we determine the success of therapy. Some of our patients want return to competitive sports. Others simply want to go for a walk with a loved one. We will review your specific goals and design a customized treatment plan.
We believe that our patients should be treated with respect and compassion. We listen attentively, review all relevant information, and use advanced technology to arrive at an accurate and complete diagnosis. We use the available medical literature to guide our decision making. When the literature does not offer a solution, we initiate a treatment plan that is customized, conservative and cost conscious. Although new technology offers many solutions not previously available, we do not abandon standard medical care. We collaborate with other health care providers such as nutritionists, physical therapists, chiropractors, fitness instructors, physicians and surgeons when we need their assistance. We are humble, lifelong students of our profession and are grateful for the opportunity to serve the people of our community.
We offer a Regenerative Medicine Consultation which includes:
- Complete review of your Medical History
- Complete Physical Examination
- MyBioProfile Exam
- Review of all Imaging Studies (xray, MRI, CT, ultrasound)
- Completion of a Diagnostic Ultrasound exam if indicated
- Explanation of your Diagnosis
- Discussion of Treatment Options Pros & Cons
- Development of a Customized Treatment Plan
- Explanation of Treatment Rationale and Review of Medical Literature
The average Regenerative Medicine therapy will cost about $4000 to $9000. More complicated cases will require more service and simple cases can be as low as $600. If you require treatment of more than one body part, we will offer a reduced rate for the additional treatments when performed at the same time.
We are a self managed medical clinic, not a franchise. Therefore, our administrative costs are significantly less. We do not charge a mandatory research fee as some clinics may. This is included with the cost of your treatment. In addition, we spend a significant amount of effort to correctly diagnose your orthopedic condition using procedures and technology not found in most medical clinics. Our physicians are experts in interventional orthopaedic procedures. We do not waste time or effort on tests or treatments that are unlikely to produce excellent results. All this effort leads to better outcomes, quicker recovery and a reduced cost.
While we do accept Medicare, PPO, and many other forms of insurance for your consultation and office visits, most regenerative medicine therapies would not be covered by your insurance.
We do accept cash, check and all major credit cards. Financing may be available.
If you have a Health Savings Account (HSA) or Flex Savings Account (FSA) you may use these for your medical care. Please confirm with your Savings Account provider.
We maintain a library of research articles for your reference.
The following links may also assist you:
Stem cells information about the biological properties of stem cells and the potential use of stem cells in research and in treating disease.
http://www.isscr.org/visitor-types/public/stem-cell-faq
Stem cell information for the public from the International Society for Stem Cell Research (ISSCR).
The US Food and Drug Administration has issued guidance on the use of human cells, tissue and cellular and tissue-based products regulated under 361 of the Public Health Service Act and 21 CFR Part 1271.
http://www.nlm.nih.gov/medlineplus/stemcells.html
Medline Plus is a consumer health database that includes news, health resources, clinical trials, and more.
http://www.mayoclinic.org/tests-procedures/stem-cell-transplant/in- depth/stem-cells/art-20048117
The staff of the Mayo clinic share information about stem cells, current and possible uses, ethical issues, and the state of research and practice.
http://learn.genetics.utah.edu/content/stemcells/scintro/
Learn about the nature of stem cells via a slideshow from the University of Utah’s Genetic Science Learning Center.