Anyone considering stem cell therapies should carefully consider their options when researching medical clinics that claim to offer such treatments. You may recall the news stories that were reported last year on cases of infection following stem cell injections. They reported that 17 people in five states were hospitalized with serious infections following injections of umbilical cord blood derived products. All but two of the illnesses were linked to a single company in California [i].
Are All Stem Cell Therapies the Same?
Before consenting to a stem cell injection, we recommend that you ask your physician the following questions:
What kind of stem cells do you use?
Umbilical cord blood products [ii] are not approved by the US Food and Drug Administration (FDA). The safety and efficacy of these products have not been tested in orthopedic applications. However, your own cells can be used when harvested from a patient’s own (autologous) bone marrow or adipose tissue (fat). These cells contain high levels of mesenchymal stem cells (MSCs) and other orthobiologics that contain anti-inflammatory and regenerative properties.
San Diego Orthobiologics Medical Group offers several different treatment options for autologous cell based therapy. These treatments include Bone Marrow Aspirate Concentrate (BMAC), Microfragmented adipose tissue (MFAT), Platelet Rich Plasma (PRP) and Endoret Plasma Rich in Growth Factors (PRGF). Each treatment offers different benefits to suit a patient’s unique orthopedic needs. We do not use donor (allogeneic) products derived from birth waste tissues (like umbilical cord blood, amniotic fluid, exosomes, or placenta) because they have not been tested for safety or efficacy and are not compliant with current FDA guidelines.
How do you process the cells?
Many clinics use basic centrifuges to separate stem cells, but the best method for obtaining the highest concentrations of regenerative autologous stems cells requires specialized equipment operated in a sterile lab setting.
San Diego Orthobiologics Medical Group established a state-of-the-art facility in Carlsbad that contains some of the most advanced Regenerative Medicine technology in the San Diego area. We process autologous same day platelet rich plasma, regenerative cell concentrates and other orthobiologics safely and at a customized dose in our Regenerative Medicine Lab.
How effective are your treatments?
Clinics or practices that sell donated stem cells do so at some risk to your health. These products are not tested for sterility or viability. Independent testing of these products has shown that they do not contain any live stem cells at all. Only live stem cells can exert the sought after beneficial therapeutic effects. These products have not been demonstrated to contain any healing properties in clinical studies.
San Diego Orthobiologics Medical Group only uses your own bone marrow or fat tissue and is able to process them using state-of-the-art technology. Same-day treatments maximize the healing potential of the fresh (not frozen) regenerative cells.
Is there scientific evidence to support your claims?
Clinics that use autologous cell based treatments are not afraid to participate in clinical trials—in fact they welcome the opportunity to do so—because they know it is important to study these treatments for safety and efficacy.
Based on our extensive experience treating orthopedic conditions with regenerative medicine therapies, San Diego Orthobiologics Medical Group is one of only six clinics in the United States selected to participate in FDA-approved clinical trials to treat knee osteoarthritis. Visit our website (Research section) for an extensive list of peer-reviewed published articles from prestigious medical journals about the different kinds of cell based therapies we offer.
It should be clear that the answer to the question “Are all stem cell therapies the same?” is a resounding “No!”. Anyone considering treatment should understand what works and what does not work. What is safe and what is risky. What is FDA compliant and what is illegal. We believe that patients deserve honest answers to these tough questions.
With decades of experience in regenerative medicine, Drs. Christopher J. Rogers and Mary A. Ambach are recognized experts in the field of Regenerative Medicine. They continue to advance the field by participating in clinical trials and serve as faculty members and lecturers at national and international medical conferences. They also serve on the board of directors for several national regenerative medicine organizations.
Dr. Christopher Rogers and colleagues are first to publish scientific review of stem cell therapy for COVID-19 patients.
, along with scientists from around the world, are first to publish a comprehensive scientific review, “Rationale for the Clinical Use of Adipose-derived Mesenchymal Stem Cells for COVID-19 patients.” Clinical trials of stem cell treatments for severe COVID-19 are currently being conducted at dozens of medical centers worldwide. Scientific studies will advance our understanding of the safety and efficacy of stem cell therapy for these seriously ill patients.
This scientific review was published in the peer-reviewed journal, Journal of Translational Medicine (Rogers, C.J., Harman, R.J., Bunnell, B.A. et al. Rationale for the clinical use of adipose-derived mesenchymal stem cells for COVID-19 patients. J Transl Med 18, 203 (2020).
Read the scientific review here:
Orthobiologics research has come a long way since the earliest reports of platelet rich plasma (PRP) in the 1980s and stem cells in the 1960s. There has been exponential growth in the number of published scientific studies on PRP and stem cells in orthopedics over the past 10 years.
Regenerative medicine is a new medical specialty that uses advancements in the study of cells and tissue engineering to understand how the body heals itself. In the field of orthopedics, regenerative treatments have evolved to capitalize on the unique healing qualities of our own cells to stimulate healing, reduce inflammation and decrease pain for a variety of musculoskeletal conditions.
The demand for regenerative treatments continues to grow as patients discover how these treatments are successfully being used to treat acute musculoskeletal injuries and degenerative conditions. More and more patients have benefited from such therapies with reduction in pain and significant improvement in their quality of life.
Regenerative Medicine in 2020
Clinical trials and research in regenerative medicine has provided more ever increasing evidence for the safety and efficacy of cell based therapies when used in orthopedics such as osteoarthritis, tendon tears, ligament injuries, low back pain, sciatica and several others conditions.
The choice of regenerative treatment depends upon multiple factors including the type and severity of injury, medical comorbidities and other issues unique to each patient. San Diego Orthobiologics Medical Group offers a number of regenerative medicine options such as:
- Platelet Rich Plasma Therapy: Growth factors and proteins in the platelets and plasma of the patient’s own blood promote tissue repair and reduce inflammation. Specific PRP formulation is customized to joints, tendons, ligament or nerves for maximum results.
- Adipose Derived Stem Cell Therapy: Fat tissue derived from your own body enables regenerative cells (such as stem cells) within your own fat tissue to work together and repair, reconstruct and replace damaged or injured tissues.
- Bone Marrow Aspiration Concentrate (BMAC): Utilizes regenerative cells that are contained within your own bone marrow. The marrow contains a rich reservoir of anti-inflammatory molecules, platelets and stem cells to stimulate your body’s ability to improve circulation, decrease inflammation and regenerate tissues.
- Prolotherapy: Medications that help regenerate tissue and relieve pain are injected into injured ligaments, tendons or joints to strengthen and improve stability in patients with osteoarthritis, ligament sprains and sports-related injuries.
The field of regenerative medicine is continuously evolving and expanding. Cell based therapies are getting acknowledgement in orthopedic surgery and have been used to accelerate healing and improve outcomes. The combined use of cells and protein scaffolds (tissue framework) are utilized for cartilage, tendon, ligament and bone tissue engineering to accelerate healing and long lasting results. Surgery to repair bone fractures or bone defects have been supplemented with cell therapy to increase bone healing and mineralization.
Many other exciting potential applications for stem cell therapy are currently being studied, not just in orthopedics, but in other specialties. The idea that a patient can bank their own stem cells to store for future use is already a reality.
However, there is still more work to be done in order to make significant progress on this field. Although there are thousands of studies published in peer-reviewed scientific journals, there is a great need for more high-quality studies and clinical trials. Continued work on standardization of processes, reporting and treatment protocols is vital. Collection of data through registries is not only important to track patient complications and outcomes, but also to guide future decisions made by insurance companies and regulators. Collaboration with a multidisciplinary team of experts in physical medicine and rehabilitation, orthopedic surgery, sports medicine, cell therapy, molecular biology and others will continue to move the field forward at a rapid pace.
Drs. Christopher J. Rogers and Mary A. Ambach of San Diego Orthobiologics Medical Group are experts and leaders in the field of regenerative medicine. They are involved in clinical trials using cell-based therapies for knee osteoarthritis and disc degeneration in the lumbar spine. They have published in multiple medical journals and Regenerative Medicine textbooks. They serve as faculty members and lecturers at national and international medical conferences and serve on the board of directors for several regenerative medicine organizations.
Bone marrow is a rich source of many types of cells. Red blood cells, white blood cells and platelets are manufactured in the marrow and released into the blood. Stem cells, were discovered in bone marrow in 1988 and have been shown to have the remarkable potential to develop into many different types of cells and promote healing.
Bone marrow contains at least two kinds of stem cells. One population, called the hematopoietic stem cell (HSC), forms all the different blood cells in the body. A second population, the mesenchymal stem cell (MSC), has the ability to transform into different cell types such as:
- Bone cells (osteoblasts and osteocytes)
- Cartilage cells (chrondrocytes)
- Fat cells (adipocytes)
- Fibrous connective tissue cells (fibroblasts)
Stem cells not only have the ability to become other types of cells, they also have powerful anti-inflammatory and immune system modifying properties to influence the healing response of injured tissues.
What is Bone Marrow Aspiration Concentrate?
Bone marrow aspiration concentrate (BMAC), is a concentration of cells that is obtained from a patient’s own bone marrow. Bone marrow aspirate is collected using a minimally invasive procedure that uses a needle to obtain bone marrow from the bone, commonly in the pelvis. The procedure is performed under local anesthesia or light sedation for comfort. The bone marrow is minimally processed in our lab to separate and concentrate the cells using centrifugation. Bone marrow processing protocols vary widely and influence the number and quality of the cells. The resulting biologic product is then injected into injured tissues using imaging guidance such as ultrasound or fluoroscopy (“real time” x-ray). The entire process is performed on the same day and is well tolerated with minimal need for pain medications.
What Conditions Can Be Treated with BMAC?
Bone marrow aspiration concentrate therapy is used for a variety of orthopedic conditions. It has been shown to decrease inflammation and aid in healing.
BMAC therapy may:
- Treat osteoarthritis by decreasing inflammation in the joint and delaying disease progression
- Protect and repair cartilage
- Stimulate bone growth to heal fractures
- Improve tendon and ligament healing caused by tears, sprains or overuse
- Slow or reverse degenerative disc disease
Patients considering BMAC stem cell therapy should seek qualified providers to provide their treatment. Stem cell therapies using a patient’s own bone marrow are compliant with current FDA regulatory guidelines.
However, other stem cell based products that contain umbilical cord blood, amniotic tissue or exosomes are not FDA compliant and should be avoided.
Dr. Christopher J. Rogers and Dr. Mary A. Ambach are board certified in Physical Medicine and Rehabilitation and have specialized training in Regenerative Medicine. They are experts in the use of Bone Marrow Aspiration Concentrate (BMAC) and other Orthobiologics for orthopedic conditions.
Safe and Effective Stem Cell Therapy
Osteoarthritis causes joint pain, stiffness, swelling, and can lead to a debilitating chronic condition. Standard treatments of physical therapy and anti-inflammatories are limited at times in controlling symptoms and improving function. The good news for patients with osteoarthritis is that there are regenerative treatment options, like stem cell therapy, to reduce pain and stimulate healing. These therapies offer a viable alternative to major surgery that requires prolonged rehabilitation. It provides hope for an improved quality of life without the risks associated with joint replacement surgery.
What is Regenerative Medicine?
Regenerative medicine is a new medical specialty that uses advancements in the study of cells and tissue engineering to understand how the body heals itself.
By using the unique healing qualities of your own cells, regenerative treatments can stimulate healing, reduce inflammation and decrease pain. Some of these therapies may even prevent the progression of joint arthritis.
Stem cell therapies using a patient’s own bone marrow or minimally manipulated adipose tissue have been shown to be safe and effective in treating osteoarthritis and other orthopedic conditions. These treatments are compliant with current FDA regulatory guidelines.
However, stem cell based products that contain umbilical cord blood, amniotic tissue cells or exosomes have unproven claims on their safety and efficacy. They require FDA approval of a Biologics License Application before they are allowed to be marketed to patients.
What Can You Expect from Stem Cell Therapy?
Stem cell therapy is performed on an out-patient basis and do not require anesthesia. Unlike invasive joint replacement surgery, they do not demand a lengthy recovery time or extensive physical therapy following treatment. These minimally-invasive treatments are performed using advanced image guidance such as ultrasound or fluoroscopy (digital x-ray). The procedure typically takes less than a couple hours to complete and patients can return to their daily activities after their treatment. Light activities are typically recommended for a few days.
Studies show that stem cell therapy derived from bone marrow concentrate improved pain and function significantly better than exercise therapy or hyaluronic acid (gel) therapy in patients with knee osteoarthritis. Another study shows that stem cell therapy from fat and bone marrow tissues resulted in significant clinical improvements in patients with symptomatic knee osteoarthritis.
More published scientific studies for orthopedic applications can be found at www.sdomg.com/fat and www.sdomg.com/bma.
Drs. Christopher J. Rogers and Mary A. Ambach of San Diego Orthobiologics Medical Group are experts and leaders in the field of regenerative medicine. They are the leading providers in San Diego who offer the most advanced regenerative treatments available for orthopedic conditions.
Dr. Chris Rogers and his team at San Diego Orthobiologics Medical Group in collaboration with Personalized Stem Cells (PSC), Inc. conduct stem cell research at their clinic in Carlsbad, California. As medical director and principal investigator for these FDA approved clinical trials, Dr. Rogers realizes the potential that stem cell therapy may have for COVID-19 patients.
Currently, Personalized Stem Cells, Inc. is awaiting FDA approval to start a new clinical trial in COVID-19 patients. Recently, they were asked by the White House Task Force to apply for an expedited FDA review of their application to treat COVID-19 patients with stem cells. In preclinical trials, stem cells have been shown to improve the lung damage and inflammation caused by viral pneumonia.
Conducting COVID-19 Stem Cell Research
Doctors based in China and Israel published positive outcomes following their stem cell treatments. Israeli doctors announced that seven patients with COVID-19 experienced 100% recovery following stem cell treatment. PSC has collaborators in Wuhan and Beijing, where similar results have been reported.
To expedite the mass production of stem cells, PSC teamed up with Calidi Biotherapeutics, a San Diego based company which provided the pre-tested master cell line. These cells facilitated fast and efficient manufacturing of more stem cells, which will allow patients to receive treatment more quickly.
Pending FDA approval, the first clinical trial will be held in San Diego in a few weeks. PSC will apply for compassionate use approval for national and international use as well. Compassionate use is a way for patients who are not eligible for clinical trials to receive treatment. These patients have serious or life-threatening illnesses for which other treatments are not available.