Stem cells are important for living organisms for many reasons. Stem cells have the remarkable potential to develop into many different cell types in the body, serving as a sort of internal repair system, dividing essentially without limit to replenish other cells so long as the person is still alive. Given their unique regenerative abilities, stem cells offer new potentials for treating diseases such as diabetes and heart disease. Of primary importance is the adult stem cell. Remarkably, it can renew itself by taking on the characteristics of other kinds of cells in tissue and organs. This ability to transform itself enables adult stem cells to maintain and repair the tissue in which they are found. Today, donated organs and tissues are often used to replace ailing or destroyed tissue, but the need for transplantable organs far outpaces the available supply. Stem cells offer the possibility of a renewable source of replacement cells and tissues to treat diseases such as macular degeneration, spinal cord injury, stroke, burns, heart disease, diabetes and other maladies.
The field of medicine devoted to treatments in which stem cells are induced to differentiate into the specific cell type to repair damaged or destroyed cell populations or tissue is called regenerative medicine.
According to a statement from FDA Commissioner Scott Gottlieb, MD from August 28, 2017, “One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine…”
Many bodily products may be considered useful for regenerative medicine. But the two most commonly used are:
- Platelet-rich plasma (PRP)
- Bone marrow aspirate concentrate (BMAC)
Blood has many different types of cells, including:
- Red blood cells that carry oxygen in the body.
- White blood cells that fight infection.
- Platelet cells that help blood clot and help the body heal from injury.
Platelet-rich plasma is a solution made from our own blood. Plasma holds many platelets. Platelets have a lot of proteins including growth factors. These proteins help control inflammation and heal the body from injury.
When you are sick or injured, your body quickly sends platelets to the area. Platelets act like “first responder” cells. They form a clot to help prevent more bleeding. Platelets also help create a foundation for new tissue to grow. In addition, they release growth factors and other proteins. These proteins attract stem cells and other cells to the area. Each of these cells is needed to help the area heal.
How is PRP made? The first step in creating PRP is to draw blood from a vein. The blood is placed into a machine called a centrifuge. It spins the blood. Spinning separates the platelets from the other blood cells. That step also increases the platelet concentration.
If your health care provider finds that you are a candidate for PRP, you will be asked to carefully review a detailed informed consent (see Patient Information Informed Consent on website). The following is a summary of the procedure:
A. Blood is taken from your arm. This is done the same way as a blood donation is done.
B. The blood is placed into a centrifuge and PRP is made. The process usually takes about 20-30 minutes. The time depends on how much blood was drawn from your arm.
C. Ultrasound or fluoroscopy (X-ray) is used to look at the injured area.
D. Your skin is cleansed and numbed using a local anesthetic.
E. Using ultrasound or fluoroscopy, a needle is gently guided to the damaged tissue or joint.
F. The PRP is injected into the damaged tissue or joint.
G. It takes 60-90 minutes to make and inject PRP.
BMAC is a concentrated form of bone marrow taken from your own body. Adult mesenchymal stem cells (MSCs) are found in bone marrow “niches” throughout the body. These cells can be used to treat damaged tissue, improve function and help control pain. BMAC has been injected into injured joints, tendons, ligaments, muscles, intervertebral discs, and other areas.
The promising field of cell-based medicine holds great potential for early-intervention treatments to cure or mitigate the effects of degenerative diseases and traumatic injury. By using your own stem cells, CurPoint’s approach empowers your body to heal itself— through orthopedic non-operative treatment that repairs, restores or replaces damaged cells to alleviate your discomfort. There is never introduction of foreign materials into your body from outside cell banks or from elsewhere. There is nothing for your body to reject; these are your cells. Our vision is truly all about you.
It should be emphasized that the use of mesenchymal stem cells for musculoskeletal conditions is still in the investigative phase. What we know for certain is that our adult stem cell populations decline as we age. We also know that the potency of our stem cells declines with age. Both these factors make us less efficient at repairing injuries to our musculoskeletal systems. Stem cells work in two ways: 1) they can renew themselves and multiply before differentiating into the type of tissue that needs repair; 2) they can secrete biochemicals that help establish a regenerative microenvironment at sites of tissue injury or damage. Thus, the near-and long-term goal of the procedure is to establish a regenerative microenvironment using your body’s autologous adult mesenchymal stem cells to naturally heal, restore, regenerate, and renew damaged areas. In doing so, it is our hope that your pain will be lessened, and your function and quality of life will be improved. Stem cells have great potential, and there have been clinical studies that show promising results, but more research is necessary.
Orthopedic surgeons have been using bone marrow derived stem cells for decades in the treatment of complex fractures, defects caused by bone tumors, and spinal fusions. Bone marrow is ideal for orthopedic uses because it contains large quantities of adult mesenchymal stem cells (MSCs). MSCs give rise to a variety of cell types, like bone cells (osteoblasts) and cartilage cells (chondrocytes). These cell types are important in fracture healing, spinal fusions, and articular cartilage repair. As important, MSCs also secrete bioactive factors that serve as biologic medicinal agents to modulate the immune response, stimulate new blood vessel formation, and encourage other local stem cells to differentiate into the types of repair cells that are most needed.
From a regulatory perspective, bone marrow derived stem cells are ideal. 1) The FDA does not consider them drugs since they are derived from the patient’s own natural reserves without the disruption of the donor tissue; 2) The FDA does not consider them to be more than minimally manipulated when they are centrifuged; 3) The FDA recognizes that they can become cell types that resemble the same cell types from which they are harvested; 4) The FDA recognizes that they are re-injected into the target tissue during the same surgical setting, thus, they are regulated as any other surgical procedure would be.
A) You have the legal and ethical right to direct what happens to your body.
B) You have the legal and ethical right to be informed about your condition/diagnosis
C) You have the legal and ethical right to fully understand the recommended surgical, medical, or diagnostic procedure(s), so that you may give or withhold your consent.
Informed consent is a cornerstone of the physician-patient relationship. To be valid, it must involve a partnership, one where patients and doctors make decisions together. Your doctor has a responsibility to disclose the nature of the proposed treatment or procedure, the relevant associated risks and hazards involved, and any other treatment or non-treatment alternatives—along with the attendant risks of those alternatives. Thus, valid informed consent is the patient granting permission for the doctor to proceed with the recommended treatment in the knowledge of the possible consequences.
I understand that the following procedure is planned for me: bone marrow aspiration and injection of the concentrated stem cells (BMAC) into my painful or damaged joint. I understand that I am being asked to voluntarily consent and to voluntarily authorize the procedure(s) described below. I am being informed that the proposed procedure(s) consists of two elements or phases. The first phase involves the harvesting of my stem cells, and the second phase involves the injection of my stem cells into my painful or damaged joint. The proposed procedure will be described in further detail below.
I. Primary proposed procedure: bone marrow aspiration (Phase1)
As the patient, you should understand that the primary proposed procedure is to remove autologous bone marrow containing mesenchymal stem cells (MSCs) from the back of the iliac crest (hip area) using sterile technique. You will be positioned on a cushioned radio-lucent table in the prone (facedown) position or the lateral (side-up) position for the procedure. Your surgeon will use a state-of-the-art fluoroscopy C-arm to image your pelvic bone. This is done to make certain the bone marrow is extracted safely from the proper spot. The C-arm will be used throughout the procedure to guide the surgeon in real-time. Once properly positioned, the surgical site will be sterilely prepped-and-draped. After anesthetizing the area with local anesthetic, your surgeon will make a small incision, then insert an aspiration device that resembles a hollow needle into the bone marrow cavity (this will be done under fluoroscopic guidance). Using a syringe, your surgeon will withdraw a sample of the liquid portion of the bone marrow. You may feel a brief sharp pain or stinging. The aspiration takes only a few minutes. Several samples may be taken from different areas to increase the number of stem cells. Once the sample is taken, your surgeon will apply pressure over the site until any bleeding stops. Small strips of specialized surgery tape will be placed over the incision to bring the skin edges together. In some instances, your surgeon may elect to suture the incision. Once the incision is closed, sterile dressings will be applied. The bone marrow aspirate will be taken to our on-site processing center for centrifugation. You can comfortably rest during this phase of the procedure.
II. Primary proposed procedure: BMAC stem cell injection (Phase 2)
Once the stem cells have been concentrated by centrifugation, the second phase of the procedure will begin. The target area will be sterilely prepped and draped using sterile technique. Local anesthetic will be used to anesthetize the injection site. The stem cell concentrate will then be injected into the target area using ultrasonic guidance, fluoroscopic guidance, needle-scope arthroscopic guidance, or any combination of these injection guidance tools. Your surgeon may elect to inject the stem cells into several different locations depending on your diagnosis. Most of the time, this can all be done with a single injection. If more than one injection is required, the process will be repeated for each injection site. In some cases, your surgeon may advise the use of other products, such platelet-rich plasma (PRP) or growth factors from other sources, that are designed to improve your outcome. Use of these ancillary products may require separate and distinct informed consent forms to be signed.
III. Duration of procedure: including Phases 1 and 2)
Phase 1 of the procedure, where the stem cells are harvested from the bone marrow, should take about 20 minutes. This includes positioning, initial imaging, prepping and draping, anesthetizing the area, aspiration of the stem cells, applying pressure to the site to stop bleeding, cleaning and closing the incision, and applying sterile dressings. There will be an approximate 20-minute break between Phase 1 and Phase 2, as the bone marrow aspirate undergoes centrifugation. Phase 2 of the procedure, where the concentrated stem cells are injected into the target site, should take about 20 minutes, depending on the number of sites to be injected. This includes using ultrasound or C-arm to inspect target site. Prepping and draping the area. Anesthetizing the target injection sites. Injecting the stem cells. Applying sterile dressings and elastic bandages (in some cases).
IV. Near and long-term goals of procedure
The near-term goals of the procedure are to allow the stem cells the opportunity to begin the process of renewal and regeneration. Your surgeon will provide you with very specific post-procedure instructions that should be followed. The long-term goals are to decrease pain and improve function. This, however, is not a guarantee or warranty that the procedure will serve its intended purpose.
V. Investigational procedure acknowledgment:
This medical procedure is still considered experimental and investigative. This means it has not yet met the standard of care in the medical community. While your surgeon believes that this procedure holds promise, there are no large research studies that have shown it to be conclusively effective. The American Academy of Orthopedic Surgeons issued a position statement on the “Use of Emerging Biologic Therapies” in December 2017 that states:
“The increasing shift to therapeutic biologic products for restoring structure and function presents new questions of safety and effectiveness. No longer reserved for treating trauma and soft tissue injuries, biologic therapies are now explored as options for osteoarthritis. As we note in the statement ‘Innovation and New Technologies in Orthopedic Surgery.’ surgeons must be aware of the scientific basis for different treatment options offered to patients, including the benefits and risks. The varying regulatory pathways by which biologic therapies come to market require additional burden for surgeons to become familiar with, the Food and Drug Administration’s current thinking with respect to the source, retrieval and/or manufacturing methods, processing, storage, and use of these products, whether alone or as part of combination products. Emerging biologic therapies may lack the demonstrated safety and effectiveness profiles of many traditional orthopedic treatments. Patient education is needed for informed consent…”
Why choose CurPoint Orthopedic?
THE CURPOINT™ DIFFERENCE
We Are Orthopedic Surgeons
Since the stem cell therapy marketplace is still in its infancy, there has been a “gold rush” mentality amongst the diverse array of medical providers vying for a stake in the stem cell space. Although there are some highly reputable stem cell treatment facilities, there are far more charlatans and interlopers looking to make a quick profit before the FDA establishes a sense of order.
Most of these vendors lack the knowledge or experience to effectively perform a series of complex and delicate procedures. Most of them are non-surgeons with varying degrees of skill: sports medicine providers, pain treatment centers and wellness clinics, among other entities. Some of these providers are legitimate and ethical, while others are not.
In sharp contrast to these businesses, CurPoint Orthopedic are surgeons, fluent in the intricate anatomy and physiology of the human body. Because of our hands-on experience with fracture care, joint replacement surgery, rotator cuff surgery, spinal surgery, and other musculoskeletal maladies, we have literally been inside of the joints and body parts our patients are now asking us to treat with stem cells.
We Are Experts in Our Field
Orthopedics is the preeminent medical specialty that focuses solely on injuries and diseases of your body’s musculoskeletal system. This complex system—which includes your bones, joints, ligaments, muscles, and nerves—allows you to move, work, and be active.
CurPoint Orthopedic was founded by an orthopedic surgeon with over thirty-years of education, training, and hands-on experience. Having preformed thousands of complex surgeries and targeted injections, we believe our knowledge and experience is unsurpassed in the evaluation and treatment of musculoskeletal conditions. We have assembled a top-notch team that approaches every patient’s care plan with the meticulous attention-to-detail surgical precision it deserves.
There is a reason why most high school, college, and professional sports teams have orthopedic surgeons as their team physicians; and there is a reason why every major hospital in the world has orthopedic surgeons on stand-by in the emergency rooms for trauma. The reason is simple, it’s because orthopedic surgeons are the world’s top experts for injuries or conditions affecting the musculoskeletal system.
We Use Your Own Stem Cells
CurPoint Orthopedic strongly believe that the best source of donor stem cells, are those that come from the patient’s themselves. Orthopedic surgeons have been using stem cells for decades in the treatment of complex fractures and to aid in the fusion of damaged joints. These stem cells are harvested from niches that lie within the bone marrow. In the operating room, surgeons harvest the actual bone marrow itself, which is then packed into fracture or fusion site.
In cell-based medicine procedures, the stem cells are harvested by aspiration of the bone marrow in an outpatient setting. This procedure is done under strict sterile conditions using the latest technology. The aspirate is then concentrated in a centrifuge and becomes Bone Marrow Aspiration Concentrate or BMAC. These cells can be used to treat damaged tissue, improve function and help control pain. BMAC has been injected into injured joints, tendons, ligaments, muscles, intervertebral discs, and other areas.
There are very few cell-based medicine providers that have the expertise and equipment necessary to perform these highly technical procedures. This is the major reason why many “stem-cell providers” use improvised products from cell and tissue banks. By using your own stem cells, CurPoint’s approach empowers your body to heal itself. There is never introduction of foreign materials into your body from outside cell banks or from elsewhere. There is nothing for your body to reject; these are your cells. Our vision is truly all about you.
We Can Handle Any Complications
Because of our experience, advanced technology, and state-of-the-art treatment facilities, complications for our procedures are extremely rare. That said, competent surgeons must always be prepared to deal with any complications, should they arise. Having dealt with major orthopedic trauma our entire careers, we have seen it all at one time or another. Our physicians have the experience and technical skill to handle any complication(s). We have admitting and surgical staff privileges at reputable local hospitals and will deploy any measures necessary to achieve an optimal outcome. Rest assured, CurPoint Orthopedic will be with you the entire time.