Medical Policy: 08.01.22
Original Effective Date: June 2014
Reviewed: April 2017
Revised: April 2017
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Mesenchymal stem cells (MSCs) are being investigated as a regenerative biologic agent because of their ability to differentiate into multiple tissue types and to self-renew. MSCs can be derived from a variety of sources, including adipose tissue, bone marrow, placenta and peripheral or umbilical blood, however, the bone marrow is currently the primary source of mesenchymal stem cell procurement. MSC therapy has been proposed as a treatment option for orthopedic indications that include but are not limited to the following:
- Knee - arthritis, meniscus tears, tendon and ligament tears, overuse injuries and other conditions
- Hip – injuries, arthritis, bursitis and other degenerative conditions
- Shoulder – arthritis, rotator cuff tears, and other shoulder conditions
- Spine and cervical conditions – back pain, pain from bulging or herniated discs, degenerated disc or pain from an extruded or torn disc
- Elbow – injuries, overuse conditions and arthritis (tendon and ligament issues)
- Hand/Wrist – arthritis and other conditions
- Foot/Ankle – ligament tears, sprains and instability of the ankle joint, an alternative to fusion or replacement surgery of the ankle
- Non-union fractures
MSCs are multipotent cells (also called stromal multipotent cells) that possess the ability to differentiate into various tissues including organs, trabecular bone, tendon, articular cartilage, ligaments, muscle, and fat. MSCs are associated with the blood vessels within bone marrow, synovium, fat, and muscle, where they can be mobilized for endogenous repair as occurs with healing of bone fractures. Bone-marrow aspirate is considered to be the most accessible source and, thus, the most common place to isolate MSCs for treatment of musculoskeletal disease. However, harvesting MSCs from bone marrow requires an additional procedure that may result in donor-site morbidity. In addition, the number of MSCs in bone marrow is low, and the number and differentiation capacity of bone marrow-derived MSCs decreases with age, limiting their efficiency when isolated from older patients.
Tissues such as muscle, cartilage, tendon, ligaments, and vertebral discs show limited capacity for endogenous repair. Therefore, tissue engineering techniques are being developed to improve the efficiency of repair or regeneration of damaged musculoskeletal tissues. Tissue engineering focuses on the integration of biomaterials with MSCs and/or bioactive molecules such as growth factors. In vivo, the fate of stem cells is regulated by signals in the local 3-dimensional microenvironment from the extracellular matrix and neighboring cells. It is believed that the success of tissue engineering with MSCs will also require an appropriate 3-dimensional scaffold or matrix, culture conditions for tissue-specific induction, and implantation techniques that provide appropriate biomechanical forces and mechanical stimulation. The ability to induce cell division and differentiation without adverse effects, such as the formation of neoplasms, remains a significant concern. Given that each tissue type requires different culture conditions, induction factors (signaling proteins, cytokines, growth factors), and implantation techniques, each preparation must be individually examined.
Regenexx® Stem Cell Procedure
Stem cells act as the repairman of the body and as people age and get injuries there are sometimes not enough of these critical repair cells getting to the injured area. The Regenexx procedures help solve this problem by greatly increasing the body’s natural repair cells and promote healing. This is accomplished by harvesting cells from the areas known to be rich in mesenchymal stem cells and then concentrating those cells in a lab before precisely re-injecting them into the damaged area in need of repair.
The Regenexx Same-Day Stem Cell Protocol is called a same-day procedure because the stem cells are harvested and reinjected in the same day. However, for most patients the complete protocol is actually a series of injections that happen over the course of about a week, depending on the individual’s situation. These injections include a pre-injection, the same day stem cell extraction and reinjection procedure, followed by a post-injection of multiple proprietary platelet mixes a few days later.
On the day of the procedure, blood is drawn from the patient’s vein from their arm. This will be processed in the lab along with the stem cell sample. The first step of the procedure is the bone marrow aspiration, the doctor will thoroughly numb the back of the hip and take a small bone marrow sample through a needle. These samples are sent to the lab which is part of the medical practice and processed.
The mesenchymal stem cells are isolated from the bone marrow sample, while some practices add platelet rich plasma (PRP) to their stem cell concentration, for this procedure a “super platelet” mix is utilized. By mixing lab prepared PRP (slow release growth factors) and platelet lysate (immediately available growth factors), adult stem cells grow many times more than with just PRP or platelet lysate alone. The goal is to deliver much greater numbers of stem cells to the injured area than the body would deliver on its own.
Once the cells are processed the patient will return and the stem cells and natural growth factors from the blood platelets are re-injected into the injured area using either real time fluoroscopy or musculoskeletal ultrasound, which allows the physician to pinpoint the exact location of the injection into the injured area as well as the dispersion of the cells into the tissues. Re-injections can be as soon as 6 weeks and it is recommended that most patients will need 2-4 injection cycles.
Common Conditions Treated:
- Osteoarthritis of the knee, hip, ankle, shoulder, hands
- Patients with non-healing bone fractures
- Certain types of injuries to the meniscus, hip labrum, shoulder labrum, shoulder SLAP lesions
- Tendon injuries such a partial rotator cuff or other partial muscle-tendon tears
- Avascular necrosis of the hip, shoulder, knee, ankle
Regenexx Network Providers
Regenexx is a national network of musculoskeletal doctors specializing in advanced regenerative medicine protocols, developed and patented by Regenexx. These physicians practice “Interventional Orthopedics” by providing non-surgical biologic therapies delivered with high accuracy through a needle. Regenexx network providers are board certified musculoskeletal medicine specialists that have joined this exclusive network. Joining this network involves extensive training in addition to having the ability to perform in depth, complex musculoskeletal exam lasting more than 25-30 minutes of hands on time with the patient is required or must be learned. This includes the ability to quantify problems of stability, nerves, muscles, joints and body symmetry.
The evidence for stem cell therapy in individuals who have various orthopedic conditions (osteoarthritis, ligament and tendon injuries, spinal conditions, non-union fractures, osteonecrosis) includes small randomized controlled trials and nonrandomized comparative trials. Relevant outcomes are symptoms, morbid events, functions outcomes, quality of life, and treatment-related morbidity. Use of mesenchymal stem cells (MSCs) for orthopedic conditions is an active area of research. Despite continued research into methods of harvesting and delivering treatment, there are uncertainties regarding the optimal source of cells and the delivery method. Studies have included MSCs from bone marrow, adipose tissue, peripheral blood, and synovial tissue. The largest body of evidence is on the use of autologous MSCs, either concentrated or expanded in culture, for cartilage repair. This evidence includes small randomized and nonrandomized comparative trials with insufficient data to evaluate health outcomes. In addition, expanded MSCs for orthopedic applications are not U.S. Food and Drug Administration (FDA) approved (concentrated autologous MSCs do not require FDA approval). Overall, there is lack of evidence that clinical outcomes are improved. Additional comparative prospective randomized clinical trials with a larger number of patients are needed to adequately compare MSC based therapies to standard treatment modalities to permit greater certainty on the effect of this treatment on net health outcomes. The evidence is insufficient to determine the effects of this technology on net health outcomes.
Mesenchymal Stem Cells (MSCs) with Demineralized Bone Matrix (DBM)
Demineralized bone matrix (DBM) is a type of allograft. It is produced through a process that involves the decalcification of cortical bone; substantially decreasing the structural strength. However, it is more osteoinductive than ordinary allograft. Although the reason for this is not completely understood, it has been speculated that the osteoinductive growth factors contained in the extracellular bone matrix are easily accessed once the mineral phase of the bone has been removed.
Cell Based: Bone graft substitutes that are cell based use cells to generate new tissue either alone or seeded onto a support matrix (e.g. in combination with allograft material). Support matrix may include xenograft (i.e. bovine) or human type I collagen. Cell based substitutes that are available include mesenchymal and other cell based products.
- Mesenchymal stem cells (MSCs) may also be administered by combining the cells with demineralized bone matrix (DBM). DBM is considered minimally processed tissue and does not require FDA approval. MSCs are multipotent stem cells that express a variety of different cell surface proteins and can differentiate into a variety of cell types. Obtained from bone marrow they have shown to differentiate into osteoblasts, chondrocytes, myocytes, adipocytes and neuronal cells.
- The use of demineralized bone matrix (DBM) with MSCs has been and continues to be investigated for various procedures, including spinal fusion and for intervertebral disc regeneration. Although currently under investigation, data published in the medical literature evaluating cell based substitutes is in preliminary stages and mainly in the form of nonhuman trials or case reports; data supporting safety and efficacy are lacking. Therefore, the use of allograft bone products containing viable stem cells, including but not limited to demineralized bone matrix (DBM) with stem cells, is considered investigational for all orthopedic applications, due to the lack of evidence supporting safety and efficacy.
Practice Guidelines and Position Statements
American Academy of Orthopedic Surgeons (AAOS)
The American Academy of Orthopedic Surgeons (AAOS) states the following: “Stem cell procedures in orthopedics are still at an experimental stage and most musculoskeletal treatments using stem cells are performed in research centers as part of controlled clinical trials.”
Concentrated autologous mesenchymal stem cells (MSCs) do not require approval by the U.S. Food and Drug Administration (FDA).
Demineralized bone matrix (DBM), which is processed allograft bone, is considered minimally processed tissue and does not require FDA approval. At least 4 commercially available DBM products are reported to contain viable stem cells:
- Allostem® (AlloSource): partially demineralized allograft bone seeded with adipose-derived MSCs
- Map3™ (rti surgical) contains cortical cancellous bone chips, DBM, and multipotent adult progenitor cells
- Osteocel Plus® (NuVasive): DBM combined with viable MSCs that have been isolated from allogeneic bone marrow
- Trinity Evolution Matrix™ (Orthofix) DBM combined with viable MSCs that have been isolated from allogeneic bone marrow
Whether these products can be considered minimally manipulated tissue is debated. A product would not meet the criteria for FDA regulation part 1271.10 if it is dependent upon the metabolic activity of living cells for its primary function. Otherwise, a product would be considered a biologic product and would need to demonstrate safety and efficacy for the product’s intended use with an investigational new drug and Biologics License Application (BLA).
No products using engineered or expanded MSCs have been approved by FDA for orthopedic applications.
In 2008, FDA determined that the mesenchymal stem cells sold by Regenerative Sciences for use in the Regenexx™ procedure would be considered drugs or biological products and thus require submission of a New Drug Application (NDA) or Biologics Licensing Application (BLA) to FDA. In 2014, a federal appellate court upheld FDA’s power to regulate adult stem cells and drugs and biologics and ruled that Regenexx cell product fell within FDA’s authority to regulate human cells, tissues, and cellular and tissue-based products. To date, no NDA or BLA has been approved by FDA for this product. As of 2015, the expanded stem-cell procedure is only offered in the Cayman Islands. Regenexx™ network facilities in the U.S. provide same-day stem-cell and blood platelet procedures, which do not require FDA approval (this information can be found on the Regenexx website under frequently asked questions (FAQ).
Prior approval is recommended. Submit a prior approval now .
See also medical policy 02.01.32 Autologous Platelet-Derived Growth Factors
See also medical policy 02.01.18 Prolotherapy
Stem Cell Therapy for Orthopedic Indications
Mesenchymal stem cell therapy including but not limited to the Regenexx Procedure is considered investigational for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue.
The use of mesenchymal stem cells (MSCs) for orthopedic conditions is an active area of research. Current available evidence on procedures using mesenchymal stem cells (MSCs) for orthopedic indications consists of small randomized and nonrandomized trials with insufficient data to evaluate health outcomes. Additional comparative prospective randomized clinical trials are needed to adequately compare MSC based therapies to standard treatment modalities to permit greater certainty on the effect of this treatment on net health outcomes. Also, there are no society guidelines that recommend the use of MSC therapy for the treatment of orthopedic indications. The American Academy of Orthopedic Surgeons (AAOS) information states, “stem cell procedures in orthopedics are still at an experimental stage and most musculoskeletal treatments using stem cells are performed in research centers as part of controlled clinical trials.” The evidence is insufficient to determine the effects of this technology on net health outcomes.
Stem Cells with Demineralized Bone Matrix (DBM) for Orthopedic Indications
Allograft bone products containing viable stem cells, including but not limited to demineralized bone matrix (DBM) with stem cells, is considered investigational for all orthopaedic applications, due to a lack of evidence supporting safety and efficacy by review of the available published peer reviewed medical literature.
Note: See regulatory information above for demineralized bone matrix (DMB) products containing viable stem cells.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 20999 unlisted musculoskeletal procedure
- 38205 blood derived hematopoietic progenitor cell harvesting for transplantation, per collection allogeneic
- 38206 blood derived hematopoietic progenitor cell harvesting for transplantation, autologous
- 38212 transplant preparation of hematopoietic progenitor cells; red blood cell removal
- 38215 transplant preparation of hematopoietic progenitor cells; cell concentration in plasma, mononuclear or buffy coat layer
- 38230 bone marrow harvesting for transplantation allogeneic
- 38232 bone marrow harvesting for transplantation autologous
- 38240 Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor
- 38241 Hematopoietic progenitor cell (HPC); autologous transplantation
- U.S. Food and Drug Administration. Ensuring Safety and Efficacy of Stem Cell Based Products Accessed May 14, 2014
- U.S. Food and Drug Administration. Untitled Letters (Biologics), Regenerative Sciences, Inc. Guidance, Compliance and Regulatory Information (Biologics) 2008 Available online at: Accessed May 14, 2014
- American Academy of Orthopaedic Surgeons (AAOS) OrthoInfo, Your connection to expert orthopaedic information, Stem Cells and Orthopaedics. Accessed May 2, 2014
- American Academy of Orthopaedic Surgeons (AAOS) OrthoInfo, Your connection to expert orthopaedic information, Frequently Asked Questions about Stem Cells. Accessed May 2, 2014
- International Congress for Joint Reconstruction (ICJR). Reports, Looking Toward the Future of Stem Cells in Orthopaedics Accessed May 15, 2014
- International Society for Cellular Therapy (ISCT), Position Paper, Minimal Criteria for Defining Multipotent Mesenchymal Stromal Cells. The International Society for Cellular Therapy Position Statement. Cryotherapy (2006)Vol. 8, No.4, 315-317.
- Sally Roberts, et al. Prospects of Stem Cell Therapy in Osteoarthritis. Regen.Med (2011) 6(3), 351-366.
- Shaul Beyth, Josh Schroeder and Meir Liebergall, Stem Cells in Bone Diseases: Current Clinical Practice. British Medical Bulletin 2011; 99:199-210
- Christopher J. Centeno and Stephen J. Faulkner, Chapter 21, The Use of Mesenchymal Stem Cells in Orthopedics. M.A. Hayat (ed), Stem Cells and Cancer Stem Cells, Volume 1, DOI 10.1007/978-94-007-1709-1-21.
- Medscape. Technology Insight: Adult Mesenchymal Stem Cells for Osteoarthritis Therapy.
- ECRI Institute. Nanotechnology May Help Speed Bone Healing. Published 2/6/2009.
- ECRI Institute. Health Technology Forecast. Autologous and Allogeneic Mesenchymal Stem Cell Therapy for Treating Osteoarthritis. November 2012.
- ECRI Institute. Emerging Technology Evidence Report. Autologous Mesenchymal Stem Cells for Treating Knee Osteoarthritis. June 2013.
- ECRI Institute Product Brief. AlloStem Stem Cell Bone Growth Substitute (AlloSource) for Orthopedic procedures. August 2013.
- PubMed. Dominici M, Le Blanc K, Mueller I, et. al. Minimal Criteria for Defining Multipotent Mesenchymal Stromal Cells. The International Society for Cellular Therapy Position Statement. Cytotherapy 2006;8(4):315-7
- PubMed. Rush SM, Hamilton GA, Ackerson LM, Mesenchymal Stem Cell Allograft in Revision Foot and Ankle Surgery: A clinical and Radiographic Analysis. J Foot Ankle Surg 2009; 48(2):163-9
- Centeno CJ, Schultz JR, Cheever M, et. al. Safety and Compliations Reporting on Re-Implantation of Culture Expanded Mesenchymal Stem Cells Using Autologous Platelet Lysate Technique, Curr Stem Cell Rews Ther, 2011, 6, 368-378
- Andre F. Steinert, Lars Rackwitz, et. al. Concise Review: The Clinical Application of Mesenchymal Stem Cells for Musculoskeletal Regeneration: Current States and Perspectives, Stem Cells Translational Medicine 2012;1:237-247.
- Rick L Lau, Anthony V. Perruccio, et. al. Stem Cell Therapy for the Treatment of Early Stage Avascular Necrosis of the Femoral Head: A Systematic Review, BMC Musculoskeletal Disorders 2014, 15:156.
- Jonathan I. Dawson, Janos Kanczler, et. al. Concise Review: Bridging the Gap: Bone Regeneration Using Skeletal Stem Cell-Based Strategies-Where Are We Now?, Stem Cells Volume 32, Issue 1 January 2014
- PubMed. Mesenchymal Stem Cells for the Treatment of Cartilage Lesions: From Preclinical Findings to Clinical Application in Orthopaedics, Filardo G, Madry H, et. al. Knee Surg Sports Traumatol Arthrosc 2013 aug;21(8):1717-29
- Wong KL, Lee KB, Tai BC et. al. Injectable Cultured Bone Marrow-Derived Mesenchymal Stem Cells in Varus Knees with Cartilage Defects Undergoing High Tibial Osteotomy: A Prospective, Randomized Controlled Clinical Trial with 2 Years Follow Up. Arthroscopy 2013; 29(12):2020-8
- Hana Yu, Adetola B Adesida and Nadr M Jomha, Meniscus Repair Using Mesenchymal Stem Cells – A Comprehensive Review. Stem Cell Research & Therapy 2015 6:86
- Orthofix Trinity Evolution Matrix Allograft with Viable Cells.
- Allosource Allostem Cellular Bone Allograft.
- RTIX Map3 Cellular Allogeneic Bone Graft.
- Nuvasive Osteocel Plus Bone Grafting.
- Centeno Christopher, Pitts John, et. al. Efficacy and Safety of Bone Marrow Concentrate for Osteoarthritis of the Hip: Treatment Registry Results of 196 Patients, Journal Stem Cell Research and Therapy 2014, Volume 4 Issue 10
- Centeno Christopher, Pitts John, et. al. Efficacy of Autologous Bone Marrow Concentrate for Knee Osteoarthritis with and without Adipose Graft, BioMed Research International September 2014
- PubMed: Veronesi F, Giavaresi G, et. al. Clinical Use of Bone Marrow, Bone Marrow Concentrate, and Expanded Bone Marrow Mesenchymal Stem Cells in Cartilage Disease, Stem Cells Dev. 2013 Jan 15;22(2):181-92
- PubMed: Hernigou P, Flouzat Lachaniette CH, et. al. Biologic Augmentation of Rotator Cuff Repair with Mesenchymal Stem Cells During Arthroscopy Improves Healing and Prevents Further Tears: A Case-Controlled Study, Int Orthop 2014 Sep;38(9):1811-8
- PubMed: Centeno CJ, Busse D, et. al. Regeneration of Meniscus Cartilage in a Knee Treated with Percutaneously Implanted Autologous Mesenchymal Stem Cells, Med Hyptheses 2008 Dec; 71(6):900-8
- PubMed: Bashir J, Sherman A., et. al. Mesenchymal Stem Cell Therapies in the Treatment of Musculoskeletal Diseases, Physical Medicine and Rehabilitation 2014 Jan;6(1):61-9
- Houdek Matthew, Wyle Cody, et. al. Stem Cell Treatment for Avascular Necrosis of the Femoral Head: Current Perspectives, Stem Cells and Cloning: Advances and Applications 2014:7 65-70
- Carpenter RS, Goodrich LR, Frisbie DD, Kisiday JD, Carbone B, Mcllwraith, CJ Centeno, and C Hidaka, Osteoblastic Differentiation of Human and Equine Adult Bone Marrow-Derived Mesenchymal Stem Cells when BMP-2 or BMP-7 Homodimer Genetic Modification is Compared to BMP-2/7 Heterodimer Genetic Modification in the Presence and Absence of Dexamethasone, J Orthop Res. 2010 October; 28(10): 1130-1337
- Peeters C.M.M., Leijs M.J.C., et. al. Safety of Intra-Articular Cell-Therapy with Culture Expanded Stem Cells in Humans: A Systemic Literature Review, Osteoarthritis Research Society International June 2013,
- PubMed: Centeno CJ, Freeman MD, Percutaneous Injection of Autologous, Culture Expanded Mesenchymal Stem Cells into Carpometacarpal Hand Joints: A Case Series with an Untreated Comparison Group, Wien Med Wochenschr 2014 Mar;164(5-6):83-7
- Centeno Christopher, Schultz John, et. al. A Case Series of Percutaneous Treatment of Non-Union Fractures with Autologous, Culture Expanded, Bone Marrow Derived, Mesenchymal Stem Cells and Platelet Lysate, Bioengineering and Biomedical Science
- Chirba MA, Sweetapple B, Hannon CP, et al. FDA regulation of adult stem cell therapies as used in sports medicine. J Knee Surg. Feb 2015;28(1):55-62. PMID 25603042
- Filardo G, Madry H, Jelic M, et al. Mesenchymal stem cells for the treatment of cartilage lesions: from preclinical findings to clinical application in orthopaedics. Knee Surg Sports Traumatol Arthrosc. Aug 2013;21(8):1717-1729. PMID 23306713
- Wong KL, Lee KB, Tai BC, et al. Injectable cultured bone marrow-derived mesenchymal stem cells in varus knees with cartilage defects undergoing high tibial osteotomy: a prospective, randomized controlled clinical trial with 2 years' follow-up. Arthroscopy. Dec 2013;29(12):2020-2028. PMID 24286801
- Wakitani S, Imoto K, Yamamoto T, et al. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. Mar 2002;10(3):199-206. PMID 11869080
- Wakitani S, Nawata M, Tensho K, et al. Repair of articular cartilage defects in the patello-femoral joint with autologous bone marrow mesenchymal cell transplantation: three case reports involving nine defects in five knees. J Tissue Eng Regen Med. Jan-Feb 2007;1(1):74-79. PMID 18038395
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- Eastlack RK, Garfin SR, Brown CR, et al. Osteocel plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study. Spine (Phila Pa 1976). Oct 15 2014;39(22):E1331-1337. PMID 25188591
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- April 2017 - Annual review, Policy revised
- April 2016 - Annual review, Policy renewed
- May 2015 - Annual review, Policy revised
- March 2015 - Interim review, Policy revised
- June 2014 - New Policy
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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