Cell Based Therapy
Cell-based therapies have created a renaissance in treatment of orthopedic conditions. They are designed to enhance what the body does naturally… heal itself. Because of their versatility, cell-based treatments fill the gap between medication and surgery for conditions such as arthritis, ligament and tendon injury.
Cellular therapy involves harvesting healthy cells, including stem cells, and precisely relocating them to the injured area. Injured tissues begin to heal and regenerate.
Stem cells, one of several healing factors contained in the concentrate harvested from your body, help change the microenvironment of the injured tissue by activating a healing cascade:
• promote anti-inflammation
• induce cell proliferation
• enhance the process of angiogenesis, the body’s natural formation of new blood vessels to help maintain supply of nutrients and removal of wastes.
• trigger stem cell migration from other parts of the body
Stem Cells are present in all of us, acting like a repair system for the body. They are sometimes referred to as “master cells” in that they have the potential to become many different specialized cell types. With increased age or chronic injury, sometimes the optimal amount of stem cells is not available. The goal of cell-based therapy is to amplify the natural repair system to keep pace with these demands and maintain healthy function of soft tissue of the musculoskeletal system.
Cellular therapies and their use in regenerative medicine hold almost infinite possibilities for curative treatments. Scientific advances in the understanding of how the body actually heals through tissue regeneration, combined with rapid developments in stem cell biology, have truly created a renaissance in medical treatment.
Bone Marrow Aspirate Concentrate (BMAC)
Mesenchymal stem cells (MSCs) found in adult bone marrow are extracted from the back of the patient's pelvis or hip bone using a special needle developed for bone marrow extraction. FDA-approved devices concentrate the bone marrow into what is called “Bone Marrow Aspirate Concentrate” (BMAC). The cells are not manipulated or altered with additives. Research has shown that therapy using MSCs is an especially good option for treating musculoskeletal conditions involving lost or damaged tissue. MSCs are able to differentiate into all the different cell types within a joint and to moderate the local inflammatory response.
- Q. Is the procedure painful?
A. With the use of bone marrow stem cells, there is some discomfort during the harvesting. This is reduced by local anesthetic given before the procedure. There is little pain during the administration of the stem cell mixture into the problem area. Discomfort may be felt for 24 to 72 hours after the procedure, but the doctor will prescribe medication to manage the pain. - Q.What is the advantage of Cell Based Therapy over PRP or Dextrose Prolotherapy?
A. Sometimes local stem cells that are activated in the PRP process have become depleted, particularly in the case of chronic injury or osteoarthritis. The demand has simply exceeded the supply. In this case, stem cells must be brought in from a different source. - Q.When will I notice improvement?
A. It depends on the patient, but typically within 1-2 weeks, with continual improvement for months after treatment. - Q.Why is PRP often used with Cell Based Therapy?
A. PRP is rich in growth factors and proteins that accelerate and boost tissue healing and repair. PRP also attracts more stem cells to the site. - Q.When can I return to normal activities?
A. There is soreness for a few days, but most people return to regular activity and work the next day. For people with jobs that require load-bearing activity (eg, heavy lifting), it is best to refrain from this type of activity as well as strenuous exercise for a while longer. - Q.Is Cell Based Therapy covered by insurance?
A. No, insurance does not cover this cellular therapy. We try to mitigate costs, however, by billing for the office visit. - Q.What is the cost of Cell Based Therapy?
A. Cell Based Therapy costs vary with type and location with ranges from $3800- $7000. 50% discount is offered for second site.
Research on Cell Based Therapy
More Information on Cell Based Therapy
- Tetta C, Consiglio AL, Bruno S, Tetta E, Gatti E, Dobreva M, Cremonesi F, Camussi G. Muscles The role of microvesicles derived from mesenchymal stem cells in tissue regeneration; a dream for tendon repair? Ligaments Tendons J. 2012 Oct 16;2(3):212-21. Print 2012 Jul.
- Shapiro E, Grande D, Drakos M. Biologics in Achilles tendon healing and repair: a review. Curr Rev Musculoskelet Med. 2015 Feb 6.
- Gosens T, Den Oudsten BL, Fievez E, van ‘t Spijker P, Fievez A. Pain and activity levels before and after platelet-rich plasma injection treatment of patellar tendinopathy: a prospective cohort study and the influence of previous treatments.Int Orthop. 2012 Apr 27.
- von Wehren L1, Blanke F, Todorov A, Heisterbach P, Sailer J, Majewski M. The effect of subacromial injections of autologous conditioned plasma versus cortisone for the treatment of symptomatic partial rotator cuff tears.Knee Surg Sports Traumatol Arthrosc. 2015 May 28.
- Valencia Mora M, Ruiz Ibán MA, Díaz Heredia J, Barco Laakso R, Cuéllar R1, García Arranz M. Cell Based Therapy in the management of shoulder rotator cuff disorders. World J Stem Cells. 2015 May 26;7(4):691-9. doi: 10.4252/wjsc.v7.i4.691.
- Evans CH. Advances in regenerative orthopedics. Mayo Clin Proc. 2013;88(11):1323-1339.
- Guelfi M, Pantalone A, Vanni D, Abate M, et al. Long-term beneficial effects of platelet-rich plasma for non-insertional Achilles tendinopathy. Foot Ankle Surg. 2015 Sep;21(3):178-81. doi: 10.1016/j.fas.2014.11.005. Epub 2014 Dec 11.
- López-Gavito E, Gómez-Carlín LA, Parra-Téllez P, Vázquez-Escamilla J. Platelet-rich plasma for managing calcaneus tendon tendinopathy and plantar fasciitis. Acta Ortop Mex. 2011 Nov-Dec;25(6):380-5.
- Gaweda K, Tarczynska M, Krzyzanowski W. Treatment of Achilles tendinopathy with platelet-rich plasma. Int J Sports Med. 2010 Aug;31(8):577-83. Epub 2010 Jun 9.
- Alderman DD, Alexander RW. Advances in regenerative medicine: high-density platelet-rich plasma and stem cell prolotherapy for musculoskeletal pain. Practical Pain Management. 2011:11(8);49-90.
- Alderman DD, Alexander RW. Harris G, Astourian PC. Stem cell prolotherapy in regenerative medicine: background, theory and protocols. J Prolotherapy. 2011;3(3):689-708.
- Baghaban Eslaminejad M, Malakooty Poor E. Mesenchymal stem cells as a potent cell source for articular cartilage regeneration. World J Stem Cells. 2014;6(3):344-354.
- Bahney CS, Miclau T. Therapeutic potential of stem cells in orthopedics. Indian J Orthop. 2012;46(1):4-9.
- Evans CH. Advances in regenerative orthopedics. Mayo Clin Proc. 2013;88(11):1323-1339.
- US Department of Health and Human Services. Stem Cell Basics: Introduction. In: Stem Cell Information. Bethesda, MD: National Institutes of Health, 2015.
- Wyles CC, Houdek MT, Behfar A, Sierra RJ. Mesenchymal Cell Based Therapy for osteoarthritis: current perspectives. Stem Cells Cloning. 2015;8:117-124.
BMAC: Procedure Snapshot
Bone marrow–derived MSC therapy, BMAC. First, a local anesthetic is applied to numb the area of extraction. The bone marrow is extracted from the back of the patient's pelvis or hip bone using a special needle developed for bone marrow extraction. The collected marrow is filtered and spun in a centrifuge to separate the platelets and stem cells to produce the bone marrow aspirate concentrate (BMAC). The cells are not altered with additives or manipulated. The BMAC is then injected back into the patient's site of injury guided by ultrasound where it can begin its accelerated regenerative healing. This same-day treatment takes about 1-2 hours. Typically 1 treatment, often with platelet-rich plasma given during the treatment or at follow-up, is sufficient.
Applications
- Osteoarthritis. Traditional treatment has primarily been to mask the pain with drugs (eg, NSAIDS or cortisone) or other treatments. Cell-based therapy distributes to damaged tissue the cells naturally used by the body to regenerate or re-grow tissue, reducing further damage and accelerating healing. In many cases, cell-based therapy can prevent the need for replacement surgery.
- Ligament and tendon injuries. Damage to these tissues is generally difficult to treat as they have poor blood flow, which is apparent from their white color. Muscles, on the other hand, are red because they have a very good blood supply. The lack of adequate blood flow makes ligaments and tendons prone to incomplete healing from injury.
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Muscle tears. Muscle tissue heals more quickly and thoroughly when regrowth of tissue is enhanced with bone marrow aspirate concentrate, BMAC, injected into the injury. Acceleration of healing helps to prevent further tissue damage caused through natural use of the muscle.
Common conditions treated:
- Osteoarthritis
- Degenerative joint disease
- Spine arthritis
- Meniscus tears
- Tendon tears
- Back pain
- Tendinitis
- Tendon pain on thumb side of wrist (De Quervains Tenosynovitis)
- Labrum tears
- Hamstring strains
- Ligament sprains, strains, and tears
- Tennis and golfers elbow
- Plantar fasciitis
- SI joint problems
Evidence Based Regenerative Medicine
The use of orthobiologics in treatment of musculoskeletal conditions is an emerging field. Some say there is no "proof" that it works. The evidence is mounting at an accelerated rate, however. Research that examines the complex biological mechanisms of cellular health and tissue regeneration is extensive, particularly the behavior of platelets, stem cells, immune system cells and natural growth factors in the blood. The clinical application of Regenerative Orthopedics has demonstrated promising results and a high safety profile.
The American Academy and Board of Regenerative Medicine was recently formed in 2016. Dr. Minotti is a dedicated student and has gained his experience and knowledge by attending dozens of medical conferences, visiting other medical practices and by reading hundreds of published research articles and textbooks.
FDA APPROVAL
At this time, the FDA has not approved any stem cell-based products for use. It has, however, issued compliance guidelines regarding the use of human cells, tissues, and cellular or tissue-based products. NTXMSK recognizes the FDA role in maintaining patient safety and welcomes regulation in this emerging field of orthopedics. All of our biological procedures are performed on the same day with minimal manipulation of blood, bone marrow, or adipose tissue & are therefore compliant with FDA CFR 21 Part 1271, falling under the same day surgery exemption in FDA rule in 1271.15 (b).