Orthobiologics is the field of medicine that harnesses the use of a patient’s own capacity to heal an injury. This innate capacity of healing comes from cells of one’s own body to repair and restore good health to damaged tissues.
The field of orthobiologics has been in existence for several decades but has become more developed in the last decade at Emory through ground-breaking research and clinical trials in treating orthopedic injuries. These therapies range from non-cell strategies such as platelet-rich plasma (PRP) to cell-based therapies such as bone marrow aspirate concentrate (BMAC) and micro-fragmented adipose tissue (MFAT).
Platelet-rich plasma is essentially whole blood taken from a patient through a routine blood draw and then processed in a centrifuge to further concentrate platelets into a volume of plasma that is then delivered to areas of injury. MFAT and BMAC are more cell-based therapies that are derived from a patients’ own lipoaspirate (fat aspirate) or bone marrow respectively that then undergoes same-day processing and then delivered to areas of injury. These therapies aid in release of growth factors and other mechanisms that help in healing of joints, ligaments and tendons.
Treatment Gaps in Orthopedic Injuries
The current standard of care treatment for non-operative musculoskeletal injuries such as osteoarthritis and chronic soft tissue (muscle, ligament, tendon) injuries involves relative rest, bracing, medications for symptomatic pain relief and comprehensive rehabilitation. Frequently, corticosteroid injections are used to decrease pain and inflammation and facilitate progressive return to function.
While the use of these modalities in this approach has long been the essential foundation for treating chronic soft tissue injuries, they are limited in their ability to change the injured micro-environment. It is addressing this micro-environment that facilitates complete healing and prevents injury progression.
More recently, evidence has shown repetitive use of corticosteroid injections actually worsen chronic soft tissue injuries and lead disease/pathology progression. It is the limitations of these conservative treatments and the lack of reliable surgical intervention that have paved the way for orthobiologics.
Typical conditions that can be treated with orthobiologics include chronic tendon, ligament and muscle injuries. Orthobiologics can also be used in place of opioids to provide longer-term pain control for joint osteoarthritis and certain spine conditions.
Addressing Unmet Needs
Clinical trials are challenging to do in these spaces. But it’s through clinical trials and randomized controlled trials that we are going to meet current and future therapeutic needs. The infrastructure of Emory Sports Medicine Center (ESMC) and the Emory Department of Orthopaedics allows their expert physicians and scientists to collaborate at an exponential level, bringing emerging orthobiologic treatments to patients at a rapid pace that has been unprecedented.
ESMC has undertaken a landmark trial comparing various cell-based therapies in patients with knee osteoarthritis. The goal of this study is to identify which of a specified number of injectable orthobiologic therapies would be most effective in treating knee osteoarthritis.
The study looked at both functional outcomes and biological markers response to orthobiologic treatments. The results will hopefully allow physicians to better select candidates, predict patient outcomes and close the osteoarthritis treatment gap using these precision cell-based therapies. Results of this trial are still undergoing analysis and should be available by 2023.
Another example of emerging orthobiologic work at EMSC is an upcoming clinical trial of an autologous growth factor therapy (AGFT), which has demonstrated to improve pain and decrease cartilage loss in pre-clinical models and also demonstrated to relieve pain at as early as 6 weeks in patients with knee osteoarthritis. AGFT is also an autologous blood derived product like PRP but with a more defined formulation that is possibly more protective for patients with osteoarthritis, however this needs to be further evaluated in a clinical trial. We are also in the process of looking at the use of IntraOsseous BMAC to treat avascular necrosis, fracture (stress) non-union and advanced osteoarthritis.
In addition to treating bone- and joint-related issues, ESMC physicians are using orthobiologics for acute and chronic soft tissue (muscle ligament, tendon) injuries. They have been engaged in bench research and clinical trials helping to define the role of orthobiologics in treating these conditions.
A common issue is a partial rotator cuff tear (RCT). Partial RCTs frequently fall into the orthopaedic treatment gap in that they often fail to resolve with standard non-surgical treatment, and surgical outcomes are inconsistent at best.
Orthobiologics like BMAC or MFAT can be injected under precision ultrasound guidance directly into these partial tear defects. Studies completed at ESMC have shown both BMAC and MFAT to improve tendon healing, decrease related pain and improve overall function in patients suffering from tendinopathy.
In some cases, we use a combination of MFAT and PRP to treat a partial RCTs. While PRP has been shown to confer some protection against re-tears, very few studies have investigated the efficacy of MFAT use in rotator cuff pathology. These agents may function in a synergistic manner, with MFAT providing a cell scaffold and PRP modulating the cellular environment to optimize healing.
Many of these therapies, while offered at Emory and other academic institutions around the country, still lack a deeper mechanistic understanding of how they work. One of the core missions of the ESMC Regenerative (Orthobiologics) Medicine Program is to bring Emory’s physicians, surgeons and scientists together to solve how emerging biological therapies can get to areas of injury and facilitate recovery.
A first step towards this has been standardizing protocols for these treatments to ensure quality control. There are limitations to these therapies, and many factors need to be taken into consideration, such as patient selection, medical conditions, and lack of uniformity of treatment and FDA regulations. Not every person is the same, and the general health state of a patient often affects the results of the treatment.
For example, smokers usually don’t do as well compared to non-smokers. Medications such as non-steroidal anti-inflammatories, aspirin, cholesterol and blood pressure medications can affect the results of the treatment.
There is variety in the different types of kits used in the preparation of these products. As a result, patient results can vary widely. The FDA, for good reason, has been vigilant about this field and transparency in therapies being offered. There have been some bad actors promising patients a cure not supported by science. As a result of this, some of the developments of this field have been limited due to some of the regulations enforced by FDA.
Orthobiologics is an exciting tool that can be used to help close the treatment gap in orthopaedics and sports medicine. These types of treatments are not a panacea, however, and should be used appropriately The ESMC regenerative medicine program is committed to using clinical trials and bench research to help physicians better understand the applications and limitations of orthobiologics.
Dr. Jayaram is an assistant professor in the department of orthopaedics and physical medicine at Emory University School of Medicine. He is a Stanford-trained clinician-scientist who specializes in non-operative sports medicine with a focus on advanced ultrasound and regenerative strategies for tendon and cartilage injuries. Dr. Jayaram currently serves as the Director of Clinical Regenerative Medicine at Emory Sports Medicine Center.
Dr. Olufade is an assistant professor of orthopedics at Emory University School of Medicine. He is trained in ultrasound and fluoroscopic-guided procedures and the use of various orthobiologics. He currently serves as sports medicine physician for several athletic teams and organizations, including the U.S. Soccer Physician Network, Atlanta Hawks and Emory University. Dr. Olufade is the team physician for Northview and Mt. Pisgah high schools and is one of the leaders of the ESMC Soccer Medicine program.