Autologous Chondrocyte Implantation
DESCRIPTION
Autologous chondrocyte implantation (ACI) is a form of tissue engineering that creates a graft from an individual’s own cartilage cells to repair defects in articular cartilage. The procedure involves surgical removal of a small piece of articular cartilage, harvesting of cells from the cartilage, growth of these cells in a specialized laboratory, and implanting the cultured cells over the cartilage lesion, with the goal of restoring resilient, durable cartilage at the site of injury.
Methods to improve the first-generation autologous chondrocyte implantation procedure include the use of a scaffold or matrix. There is currently one FDA approved matrix-induced autologous chondrocyte implantation product. In 2016, MACI® (matrix-induced autologous chondrocyte implantation [ACI]; Vericel Corporation) received FDA approval for the repair of symptomatic, full-thickness cartilage defects of the knee in adults. MACI is composed of biocompatible carbohydrates, protein polymers, or synthetics and is supplied in a sheet cut to size and fixed with fibrin glue. This procedure is considered technically easier and less time-consuming than the first-generation technique, which required suturing of a periosteal or collagen patch and injection of chondrocytes under the patch. In 2017, production of the first-generation product, Carticel, was phased out. In 2021, the FDA approved Agili-C™ which is a cell-free biocompatible and biodegradable tapered-shape implant for the treatment of knee-joint surface lesions without severe osteoarthritis. Agili-C acts as a 3-dimensional scaffold that purportedly supports and promotes the regeneration of the articular cartilage and its underlying subchondral bone.
POLICY
Autologous chondrocyte implantation for the treatment of articular cartilage defects of the knee is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Autologous chondrocyte implantation for the treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Autologous chondrocyte implantation is considered medically appropriate if ALL of the following are met:
Treatment of articular cartilage defects of the knee when ALL of the following are met:
Presence of focal, full thickness (grade III or IV) unipolar lesions of the patella or the weight bearing surface of the femoral condyles or trochlea that are at least 1.5 cm2 in size
Defect was caused by acute or repetitive trauma
There is evidence of growth plate closure in adolescents
There is a clinical determination that the individual is not yet a candidate for joint replacement
Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge Grade II or less), and normal appearing hyaline cartilage surrounding the border of the defect
Normal knee biomechanics, or alignment and stability will be achieved concurrently with autologous chondrocyte implantation
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of ACI for other conditions/diseases.
SOURCES
American Academy of Orthopaedic Surgeons. (2010, December). The diagnosis and treatment of osteochondritis dissecans: guideline and evidence report. Retrieved October 26, 2018 www.aaos.org.
Basad, E., Wissing, F., Fehrenbach, P., Rickert, M., Steinmeyer, J., & Ishaque, B. (2015). Matrix-induced autologous chondrocyte implantation (MACI) in the knee: clinical outcomes and challenges. Knee Surgery, Sports Traumatology, Arthroscopy, 23 (12), 3729-3735. Abstract retrieved April 21, 2017 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (5:2022). Autologous chondrocyte implantation for focal articular cartilage lesions (7.01.48). Retrieved November 13, 2023 from https://www.bcbsaoca.com/eps/. (55 articles and/or guidelines reviewed)
Dhillon, J., Decilveo, A. P., Kraeutler, M. J., Belk, J. W., McCulloch, P. C., & Scillia, A. J. (2022). Third-generation autologous chondrocyte implantation (cells cultured within collagen membrane) is superior to microfracture for focal chondral defects of the knee joint: systematic review and meta-analysis. Arthroscopy: The Journal of Arthroscopic & Related Surgery, 38 (8), 2579–2586. Abstract retrieved November 14, 2023 from PubMed database.
Guo, G.H., Tseng, F.J., Wang, S.H., Chen, P.J, Shyu, J.F., Weng, C.F., et al. (2020). Autologous chondrocyte implantation versus microfracture in the knee: A meta-analysis and systematic review. The Journal of Arthroscopic and Related Surgery, 36 (1), 289-303. (Level 2 evidence)
Hu, M., Li, X., & Xu, X. (2023). Efficacy and safety of autologous chondrocyte implantation for osteochondral defects of the talus: a systematic review and meta-analysis. Archives of Orthopaedic and Trauma Surgery, 143 (1), 71–79. Abstract retrieved November 14, 2023 from PubMed database.
Migliorini, F., Eschweiler, J., Götze, C., Driessen, A., Tingart, M., & Maffulli, N. (2022). Matrix-induced autologous chondrocyte implantation (mACI) versus autologous matrix-induced chondrogenesis (AMIC) for chondral defects of the knee: a systematic review. British Medical Bulletin, 141 (1), 47–59. (Level 1 evidence)
Na, Y., Shi, Y., Liu, W., Jia, Y., Kong, L., Zhang, T., Han, C., & Ren, Y. (2019). Is implantation of autologous chondrocytes superior to microfracture for articular-cartilage defects of the knee? A systematic review of 5-year follow-up data. International Journal of Surgery, 68, 56–62. (Level 1 evidence)
National Institute for Health and Clinical Excellence (NICE). (2017, October). Autologous chondrocyte implantation for the treating symptomatic articular cartilage defects of the knee. Retrieved February 11, 2020 from http://www.nice.org.uk/guidance/ta89/chapter/1-Guidance.
Niemeyer, P., Albrecht, D., Andereya, S., Angele, P., Ateschrang, A., Aurich, M., et al. (2016). Autologous chondrocyte implantation (ACI) for cartilage defects of the knee: a guideline by the working group “Clinical Tissue Regeneration” of the German Society of Orthopaedics and Trauma (DGOU). The Knee, 426-435. (Level 2 evidence)
U. S. Food and Drug Administration. Vaccines, Blood & Biologics. 2016 Biological License Application Approvals. MACI. Retrieved April 21, 2017 from https://www.fda.gov/.
U.S. Food and Drug Administration. Medical Devices. (2022, March). Premarket Approval Database. P210034, Agili-C. Retrieved November 14, 2023 from https://www.fda.gov/.
Winifred S. Hayes, Inc. Health Technology Assessment. (2020, August; last update search August 2023). Matrix-induced autologous chondrocyte implantation (MACI) procedure for repair of articular cartilage of the knee. Retrieved November 13, 2023 from www.Hayesinc.com/subscribers. (63 articles and/or guidelines reviewed)
Zamborsky, R., & Danisovic, L. (2020). Surgical techniques for knee cartilage repair: An updated large-scale systematic review and network meta-analysis of randomized controlled trials. Arthroscopy, 36 (3), 845–858. Abstract retrieved November 14, 2023 from PubMed database.
ORIGINAL EFFECTIVE DATE: 10/1998
MOST RECENT REVIEW DATE: 12/14/2023
ID_BT
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