Frequently Asked Questions for Patients
What is regenerative medicine?
Regenerative medicine is an emerging branch of medicine that seeks to use cell therapies to create living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage or congenital defects. Regenerative medicine is being used to pioneer new treatments in the care of heart, liver, pancreatic, lung and many other conditions.
An emerging focus of regenerative medicine is musculoskeletal care, which is care for patients with conditions affecting bone, joints, cartilage, meniscus, tendons and ligaments. Currently, standard treatment options for these conditions remain limited. Cell therapies are being explored as a means to improve treatments for patients with conditions including degenerative joint disease, osteoarthritis, tendinopathy (tendinitis and tendinosis), chondral (cartilage) defects, plantar fasciitis and ligament injuries (Malanga 2014, Pourcho 2015). The hope is to relieve pain, restore function and improve quality of life for patients suffering from these conditions.
What is the Regenerative Medicine program at Swedish?
The Swedish Regenerative Medicine program offers two types of cell therapies – platelet-rich plasma (PRP) and Bone Marrow Concentrate Aspirate (BMAC) – for patients with musculoskeletal conditions such as degenerative joint disease and osteoarthritis. These cell therapies are also known as “orthobiologics” – substances found naturally in human cells that can be used to help injuries heal more quickly (AAOS, Chu 2018).
Swedish physicians may present these types of treatment alternatives to patients when several other treatment options have failed. Physicians discuss traditional and alternative treatments in full with each patient to ensure they understand their options and receive the best care possible. These treatment options are only considered when physicians and patients agree that the potential benefits outweigh the known risks, such as infection and inflammation.
What are orthobiologics?
Orthobiologics is a term used to describe substances that are taken from human cells, tissues, bone and blood to be used as a treatment option to accelerate healing. Some research findings indicate that use of orthobiologics may help the healing process. Examples of orthobiologic substances are growth factors, bone morphogenetic protein and stem cells.
Why is Swedish involved in research and treatment with orthobiologics?
Swedish is committed to constantly innovating to find the best treatment options for our patients. The motivation to advance our knowledge about the effective use of orthobiologics is grounded in their potential as less expensive, less invasive and more effective treatment options than the current nonsurgical approaches to treating acute and chronic musculoskeletal injuries. We are also investigating their efficacy to delay or avoid surgical intervention.
The traditional “standard of care” for these injuries is often injection with corticosteroid and local anesthetic. Recent studies demonstrate potential harm when these treatments are injected into certain tendon/intra-articular sites such as the Achilles attachment or the elbow (Coombs 2013). Ethically, the rising concern about potential harm from corticosteroid injections obligates our clinicians to investigate appropriate alternatives, including biological ones.
Orthobiological treatments also provide an opportunity to avoid potential future surgical procedures, and although a minority of patients may still progress to surgery, the hope is that regenerative medicine techniques will reduce the overall cost of care for joint and tendon issues by reducing the need for orthopedic surgery and ancillary costs associated with lost days at work.
What is platelet-rich plasma (PRP)?
Platelet-rich plasma (PRP) is a concentrate of platelets and plasma proteins derived from whole blood, which is centrifuged to remove red blood cells. Platelets contain hundreds of growth factors that have a role in tissue repair and healing. Although we are stilling learning about PRP, laboratory studies have shown that the increased concentration of growth factors in PRP can potentially speed up the healing process. Preliminary research in humans is underway.
What conditions might respond to PRP?
PRP is being explored in the treatment of several musculoskeletal conditions, including:
- Chronic tendon injuries (e.g. tennis elbow)
- Knee arthritis and hip arthritis and tendinitis (Cook, 2018, Lee 2019, Fitzpatrick 2018)
- Chondral (cartilage) injuries
- Acute ligament injuries
Surgeons might also use PRP in the treatment of certain fractures and in some knee and hip surgeries.
What is BMAC?
Bone marrow aspirate concentrate (BMAC) is an orthobiologic derived from a patient’s own bone marrow. BMAC studies have recently shown encouraging results for improved pain and function at 12 months for patients with chronic tendinopathy, chondral defects and osteoarthritis. Several groups have demonstrated that BMAC is safe for patient use and has potential to improve pain and activity level in patients with various knee pathologies (Sources: Hauser and Orlofsky 2013, Centeno et al 2014, Kim et al 2014; Pascual-Garrido et al 2012, Chahla et al 2016, Gobbi et al 2015).
What does the evidence show about the safety and efficacy of PRP?
There are several research studies currently underway to evaluate the effectiveness of PRP treatment.
At this time, the results of these studies are inconclusive because the effectiveness of PRP can vary, depending on the area of the body being treated, the overall health of the patient, and whether the injury is acute or chronic.
However, preliminary clinical studies of PRP’s efficacy for treating injuries to joints, tendons and ligaments show promising results. These treatments have a good safety profile, with few major complications. (Sources: Malanga 2014, Kon et al. 2013, Sundman et al. 2014, Chahla et al.2016, Riboh et al. 2016, Fitzpatrick et al 2017, Campbell et al. 2015).
Although these results are promising, the evidence base is still evolving, and we track this closely to ensure we provide our patients the best counsel and care. Swedish communicates openly and honestly with our patients, so they are aware of the full range of treatment options, and that PRP care is not covered by insurance, therefore out of pocket expenses are expected.
How extensively is Swedish using PRP and BMAC to treat patients? What does their data show about the safety and efficacy of these procedures?
At Swedish, only a small proportion of our patients are treated with PRP and BMAC.
Between 2015 and March 2018, Swedish’s Spine Sports and Musculoskeletal Medicine clinics saw 16,584 patients. Of those, 697 (4.2%) received PRP procedures. Only 37 patients of 6,537 (0.5%) received BMAC procedures. In all, less than 5% of the Clinic’s patients chose treatment plans that include orthobiologic treatments such as PRP and BMAC.
Of the 697 patients treated with PRP since 2015, there have been no reported infections, and only one reported synovitis reaction (a temporary inflammatory reaction that required no additional treatment). Approximately 60-80% of patients report improvements (depending on the treated area) in pain, function and quality of life. By comparison, approximately 30-40% of patients experience a placebo effect. We expect our final results to be statistically significant.
At Swedish, BMAC treatments may be offered as a last resort to avoid a potential surgical procedure, and a minority of patients are expected to progress to surgery. No procedural complications have been reported to date as a result of the procedure. However, 2 of the 37 patients treated in 2018 have progressed to surgery despite their BMAC procedure. We don’t have enough longitudinal data on efficacy yet. Most of our data on BMAC is safety data at this time. More outcomes data is expected to be collected in the coming months.
How else is Swedish currently using orthobiologics?
At Swedish, a very small proportion of our patients are treated with orthobiologics.
Swedish only offers treatments using cells that are obtained from a person’s own bone marrow, which avoids ethical concerns around the use of embryonic cells from fetal tissue as well as potential rejection and safety concerns associated with umbilical cord-derived products.
Several of Swedish’s Orthopedic colleagues are using orthobiologics as adjunctive therapy, primarily for intraarticular applications in the hip and knee and peritendinous applications in the elbow (and some limited applications in the foot/ankle).
Additionally, sports medicine specialists at Swedish are both skilled and certified in the use of musculoskeletal ultrasound, which serves as imaging guidance to ensure accurate and safe delivery at the injection site (Malanga 2016).
What does Swedish charge for these treatments?
Swedish has deliberately set pricing for PRP and BMAC approximately 25 percent lower than the market average in an effort to keep the costs as affordable as possible for patients who wish to choose this option.
Does insurance cover these treatments?
Few insurance plans offer reimbursement for PRP at this time.
It is often the case that insurance does not cover cutting-edge medicine. We are continuing to publish data on the safety and efficacy of these treatments to help inform insurance companies. As more data is made available, payers will have ample data to choose which treatments are safest and most effective.
Meanwhile, we offer these treatments, when appropriate, as part of our care plan for patients who choose to pursue them, particularly when other treatments have failed.
This approach allows us to contribute to a developing body of research and data about these treatments.If these studies show that they are more effective overall compared to the standard of care, we hope insurance companies will agree to cover them.
What research is Swedish doing in the area of regenerative medicine?
Swedish is participating in ongoing data collection and clinical research on the efficacy and safety of regenerative treatments in musculoskeletal care.
We maintain a confidential patient registry documenting safety and outcomes data, as part of a larger multicenter collaborative data collection in partnership with several other leading academic institutions. Several of the group’s findings have already been published in peer-reviewed medical journals.
Swedish uses evidence-based patient reported outcomes (PRO) tools to track safety and quality outcomes for all of our patients treated with orthobiologics so that we can continue to advance the evidence base around safety and efficacy for this treatment option.
How do you ensure patients are fully informed about these therapies?
Swedish is committed to the highest ethical standards in patient care and transparency.
We partner with patients to develop a treatment plan that is understandable, responsive to their wishes, and strives for the least invasive options first. Most patients who seek orthobiological treatments do so because their symptoms do not respond to traditional treatments.
Is there anything you want to say about the way these therapies were presented in the KING-TV segment? Some have suggested it was misleading.
The interview was intended to expose a general audience to this potential treatment option and to provide information that could facilitate conversations with their health care providers.
A brief TV segment does not allow for a full discussion of treatment options and their risks and benefits, as we routinely do with our patients one-on-one. It is impossible to recreate the thorough conversations we have with patients in the examination room in a 6-minute televised segment. Our physicians typically spend 30-60 minutes with each patient to fully discuss treatment options and individualize care.
In the KING-TV appearance, Dr. Pourcho used an analogy to try to help patients understand the very complex concept of how regenerative therapies may provide a healing response. Swedish did not intend to confuse viewers. But we have taken the feedback we have received as a learning opportunity for how we can communicate these concepts more effectively with a general audience in the future.
This has been important feedback for us about the need to carefully label sponsored content. We are committed to doing that going forward.
We removed the video from YouTube when this concern was brought to our attention.
Kaiser Health News published an unfavorable story about the video and about these kinds of treatments. What is your response to the article?
There are aspects of the story that mischaracterize how we practice medicine at Swedish. We strive to meet the highest standards of transparency, safety and quality of care. Our primary concern is partnering with our patients to ensure that we are providing care that meets their needs and goals. Unfortunately, this did not come through in the Kaiser Health News story.
A complete and balanced story would have included mention that we have seen promising results in many of our patients at Swedish, that we are part of a multicenter data collection and registry in partnership with other leading academic institutions, and that we do everything we can to ensure that patients who choose this treatment option are fully informed of risks and benefits before they decide to pay out of pocket for this treatment.
Should the public be concerned about stem cell therapies?
Concerns about unregulated stem cells are appropriate and legitimate. However, the research on cell therapies and orthobiologics that is underway at Swedish and many other elite hospitals is a far cry from the snake oil clinics targeted by the FDA. Swedish is proud of our commitment to exploring cutting-edge treatments that can improve our patients’ lives. Our research in this area is rigorous and professional, and we will use the results to inform our patient care moving forward.
1. Chu CR, Rodeo S, Bhutani N, et al. Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg. 2018;27(2):e50–e63. doi:10.5435/JAAOS-D-18-00305
2. Michael Goldin & Gerard A. Malanga (2013) Tendinopathy: A Review of the Pathophysiology and Evidence for Treatment, The Physician and Sports Medicine, 41:3, 36-49, DOI: 10.3810/psm.2013.09.2019
3. Lee, W. , Kim, H. J., Kim, K. , Kim, G. B. and Jin, W. (2019), Intra‐Articular Injection of Autologous Adipose Tissue‐Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo‐Controlled Clinical Trial. STEM CELLS Translational Medicine. doi:10.1002/sctm.18-0122
4. Centeno C, Pitts J, Al-Sayegh H, Freeman M. Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int. 2014;2014:370621. doi:10.1155/2014/370621
5. Chahla J, Dean CS, Moatshe G, Pascual-Garrido C, Serra Cruz R, LaPrade RF. Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Orthop J Sports Med. 2016;4(1):2325967115625481. Published 2016 Jan 13. doi:10.1177/2325967115625481
6. Coombes BK, Bisset L, Brooks P, Khan A, Vicenzino B. Effect of Corticosteroid Injection, Physiotherapy, or Both on Clinical Outcomes in Patients With Unilateral Lateral Epicondylalgia: A Randomized Controlled Trial. JAMA. 2013;309(5):461–469. doi:10.1001/jama.2013.129
7. Fitzpatrick, J., Bulsara, M. K., O’Donnell, J., McCrory, P. R., & Zheng, M. H. (2018). The Effectiveness of Platelet-Rich Plasma Injections in Gluteal Tendinopathy: A Randomized, Double-Blind Controlled Trial Comparing a Single Platelet-Rich Plasma Injection With a Single Corticosteroid Injection. The American Journal of Sports Medicine, 46(4), 933–939. https://doi.org/10.1177/0363546517745525
8. Fitzpatrick, J., Bulsara, M., & Zheng, M. H. (2017). The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials. The American Journal of Sports Medicine, 45(1), 226–233. https://doi.org/10.1177/0363546516643716
9. Gobbi A, Fishman M. Platelet-rich Plasma and Bone Marrow–derived Mesenchymal Stem Cells in Sports Medicine. Sports Medicine and Arthroscopy Review, Volume 24, Number 2, June 2016, pp. 69-73(5)
10. Hauser, R. A., & Orlofsky, A. (2013). Regenerative Injection Therapy with Whole Bone Marrow Aspirate for Degenerative Joint Disease: A Case Series. Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders. https://doi.org/10.4137/CMAMD.S10951
11. Kon E, Filardo G, Di Matteo B, Marcacci M. PRP for the treatment of cartilage pathology. Open Orthop J. 2013;7:120–128. Published 2013 May 3. doi:10.2174/1874325001307010120
12. Lee SY, Kim W, Lim C, Chung SG. Treatment of Lateral Epicondylosis by Using Allogeneic Adipose‐Derived Mesenchymal Stem Cells: A Pilot Study. Stem Cells Translational and Clinic Research 2015; 33: 2995-3005.
13. Lee WS, Kim HJ, Kim KI, Kim GB, Jim W. Intra-Articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo-Controlled Clinical Trial. Stem Cells Translational Medicine 2019; 00: 1-8.
14. Sussman WI, MautnerK , and Malanga G. The role of rehabilitation after regenerative and orthobiologic procedures for the treatment of tendinopathy: a systematic review. Regenerative Medicine 2018 13:2, 249-263
15. Malanga G, Nakamura R. The role of regenerative medicine in the treatment of sports injuries. Phys Med Rehabil Clin N Am. 2014 Nov;25(4):881-95. doi: 10.1016/j.pmr.2014.06.007.
16. Malanga G, Goldin M. PRP: review of the current evidence for musculoskeletal conditions. Curr Phys Med Rehabil Rep (2014) 2:1–15. DOI 10.1007/s40141-013-0039-5
17. Marks P, Gottlieb S. Balancing Safety and Innovation for Cell-Based Regenerative Medicine. N Engl J Med 2018; 378:954-959. DOI: 10.1056/NEJMsr1715626
18. Cianca JC, Jayaram P. Musculoskeletal Injuries and Regenerative Medicine in the Elderly Patient Phys Med Rehabil Clin N Am 28 (2017) 777–7ul94.
19. Malanga G, Abdelshahed D, Jayaram P. Orthobiologic Interventions Using Ultrasound Guidance. Phys Med Rehabil Clin N Am 27 (2016) 717–731
20. Campbell KA, Erickson BJ, Saltzman BM, Mascarenhas R, et. al. Is Local Viscosupplementation Injection Clinically Superior to Other Therapies in the Treatment of Osteoarthritis of the Knee: A Systematic Review of Overlapping Meta-analyses. Arthroscopy: The Journal of Arthroscopic and Related Surgery, 2015; 31:2036-2045.
21. Bashir J, Sherman A, Lee H, Kapan L, Hare JM. Mesenchymal Stem Cell Therapies in the Treatment of Musculoskeletal Diseases. PM R 2014;6:61-69.
22. Kim JD, Lee GW, Jung GH, Kim CK, Kim T, Park JH, Cha SS, You YB. Clinical outcome of autologous bone marrow aspirates concentrate (BMAC) injection in degenerative arthritis of the knee. Eur J Orthop Surg Traumatol (2014) 24:1505–1511. DOI 10.1007/s00590-013-1393-9.
23. Moatshe G, Morris ER, Cinque ME, Pascual-Garrido C, Chahla J, Engebretsen L, Laprade RF. Biological treatment of the knee with platelet-rich plasma or bone marrow aspirate concentrates: A review of the current status. Acta Orthopaedica 2017; 88 (6): 670–674.
24. Khan M, Bedi A. Cochrane in CORR: Platelet-rich Therapies for Musculoskeletal Soft Tissue Injuries (Review). Clin Orthop Relat Res. 2015;473(7):2207–2213. doi:10.1007/s11999-015-4207-z.
25. Pascual-Garrido, Cecilia, A. Rolón, and A. Makino. "Treatment of chronic patellar tendinopathy with autologous bone marrow stem cells: a 5-year-followup." Stem cells international 2012. https://doi.org/10.1155/2012/953510.
26. Grambart ST. Sports Medicine and Platelet-rich Plasma Nonsurgical Therapy. Clin Podiatr Med Surg 32 (2015) 99–107. http://dx.doi.org/10.1016/j.cpm.2014.09.006
27. Pourcho AM, Hall MM. Percutaneous Ultrasonic Fasciotomy for Refractory Plantar Fasciopathy After Failure of a Partial Endoscopic Release Procedure. PM R 7 (2015) 1194-1197.
28. Cook CS, Smith PA. Clinical Update: Why PRP Should Be Your First Choice for Injection Therapy in Treating Osteoarthritis of the Knee. Current Reviews in Musculoskeletal Medicine (2018) 11:583–592. https://doi.org/10.1007/s12178-018-9524-x
29. Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. The American Journal of Sports Medicine, Vol. 44, No. 4. DOI: 10.1177/0363546515624678
30. Riboh, J. C., Saltzman, B. M., Yanke, A. B., Fortier, L., & Cole, B. J. (2016). Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. The American Journal of Sports Medicine, 44(3), 792–800. https://doi.org/10.1177/0363546515580787
31. Sundman, E. A., Cole, B. J., Karas, V., Della Valle, C., Tetreault, M. W., Mohammed, H. O., & Fortier, L. A. (2014). The Anti-inflammatory and Matrix Restorative Mechanisms of Platelet-Rich Plasma in Osteoarthritis. The American Journal of Sports Medicine, 42(1), 35–41. https://doi.org/10.1177/0363546513507766
32. Vaught MS, Cole BJ. Coding and Reimbursement Issues for Platelet-Rich Plasma. Operative Techniques in Sports Medicine 2011; 19:185-189.
33. Hellickson, J., et al. (2017). An Orthopedic Cost Reduction Strategy for Self FundedEmployers. Regenexx.
34. Centeno, C. (2017, October 27). Why Interventional Orthopedics will be the Next Interventional Cardiology; Retrieved from https://www.youtube.com/watch?v=8K8UA7-OR6Q.
35. Centeno, C. (2018, June 13). Regenexx and Edison Health: What Does This Mean?; Retrieved from https://www.regenexx.com/regenexx-edison-health-mean/.
36. CFR – Code of Federal Regulations Title 21. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271.
37. Mafi, R., et al. (2011). Sources of adult mesenchymal stem cells applicable for musculoskeletal applications - a systematic review of the literature. Open Orthop J, 5 Suppl 2: p. 242-8.
38. Centeno, C., et al. (2014). Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int, p. 370621.
39. Centneo, C. (2014, August 31) What is platelet Lysate?; Retrieved from https://www.regenexx.com/what-is-platelet-lysate/.
40. Dhillon, M.S., et al. (2014). Orthobiologics and platelet rich plasma. Indian J Orthop, 48(1), p. 1-9.
41. Hernigou, P., et al. (2014). Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop, 38(9), p. 1811-8.
42. Chase, D. (2017), The CEO’s Guide to Restoring the American Dream: How to Deliver World Class Health Care to Your Employees at Half the Cost, Bellingham, WA.
43. Ittleman, A. (2017, October 30). How the FDA Should Use Its Authority to Regulate Human Cells. The Regulatory Review, Penn Law. https://www.theregreview.org/2017/10/30/ittleman-fda-regulate-human-cells/
44. Gottlieb, S., et al. Balancing Safety and Innovation for Cell-Based Regenerative Medicine. New England Journal of Medicine, 2018, p. 954-959.
45. Speer, EW. Orthobiologics: A Pivotal Shift in Orthopedic Medicine and the Emergence of Interventional Orthopedics. 8/14/2018. https://www.mgma.com/MGMA/media/files/fellowship%20papers/2018%20Fellows%20Papers/Orthobiologics.pdf?ext=.pdf
46. Carstairs A, Genever P. Stem cell treatment for musculoskeletal disease. Curr Opin Pharmacol 2014;16:1–6.
47. Freitag J, Bates D, Boyd R et al. Mesenchymal stem cell therapy in the treatment of osteoarthritis: Reparative pathways, safety and efficacy—A review. BMC Musculoskelet Disord 2016;17:230.
48. Vega A, Martin‐Ferrero MA, Del Canto F et al. Treatment of knee osteoarthritis with allogeneic bone marrow mesenchymal stem cells: A randomized controlled trial. Transplantation 2015;99:1681–1690.
49. Pers YM, Ruiz M, Noel D et al. Mesenchymal stem cells for the management of inflammation in osteoarthritis: State of the art and perspectives. Osteoarthritis Cartilage 2015;23:2027–2035.
50. Wei CC, Lin AB, Hung SC. Mesenchymal stem cells in regenerative medicine for musculoskeletal diseases: Bench, bedside, and industry. Cell Transplant 2014;23:505–512.
51. Orozco L, Munar A, Soler R et al. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: Two‐year follow‐up results. Transplantation 2014;97:e66–e68.