Intended for U.S. health care professionals only
Repair Knee Cartilage Defects Using a Patient’s Own Cells
MACI is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement. MACI can be delivered via mini-arthrotomy and is now approved for arthroscopic delivery in ≤4 cm2 accessible defects of the knee.
Knee cartilage injuries will often get worse with time, if left untreated
In patients undergoing cell-based knee cartilage restoration, lesions can progress and new lesions can form as time between cartilage biopsy and implantation increases.1 For patients with ≤4 cm2 accessible defects of the knee, early diagnosis and treatment may minimize lesion progression and the need for open ACI.1 If conservative treatment has not worked to relieve pain associated with knee cartilage damage, MACI may be an appropriate treatment option.
Cartilage defect expansion1
0.6 cm² mean change in defect size between biopsy & implantation
0.11 cm² increase in defect expansion per month delay to implantation
New high-grade cartilage defects1
16.2% of patients developed a new high-grade cartilage defect
155 days mean time between cartilage biopsy & implantation
MACI is autologous chondrocyte implantation, simplified2
MACI is less invasive—may be done through a mini-arthrotomy or arthroscopy.
MACI is reproducible—regardless of implantation technique or defect size, MACI delivers a controlled, uniform dose of characterized cells to the defect area.
MACI is simplified—does not require supplemental suture fixation.
MACI vs. microfracture: improvements in pain and function3
A significantly greater proportion of patients treated with MACI experienced clinically meaningful improvements in both pain and function at 2 years when compared to microfracture.3
In a follow-up extension study, improvements in pain and function at Year 2 were maintained with MACI at Year 5.4
Mean patient-reported KOOS scores at year 2 and year 54
Baseline KOOS Scores for MACI patients:
37.1 Pain/15.4 Function
Baseline KOOS Scores for Microfracture patients:
35.2 Pain/11.9 Function
Patient-reported KOOS responder rates at week 104
The responder rate was higher with MACI when compared with microfracture (P=0.016). Response is defined as ≥10-point improvement in both pain and function.3
MACI
Microfracture
MACI is a 3rd generation ACI, offering a simplified way to deliver cells2
MACI has proven results3,4 with over 21 years of clinical experience.5
MACI is FDA approved based on results from the phase 3 SUMMIT clinical study.3
MACI is the only biologic knee cartilage therapy to gain FDA approval through the Biologics License Application.6
MACI results have been reported in a growing body of literature, including nearly 50 publications and 5 randomized controlled trials.7
Manufactured in accordance with quality GMP standards
MACI is aseptically manufactured from a patient’s autologous cells in an FDA licensed facility using only sterile materials.
Manufacturing clean rooms maintain the highest cleanliness standards through automated environmental controls and monitoring.
Each phase of manufacturing is monitored and tested for microbial contamination.
Our scientists and engineers are protected by pre-sterilized gowning materials for the safe production of MACI.
Uniform Loading Unit (ULU™)
A patient’s characterized cells are distributed onto the MACI membrane in a density of 500,000 to 1,000,000 per cm2 using the proprietary Uniform Loading Unit (ULU). Uniform loading allows for the application of a consistent dose of cells to the defect in a less invasive surgical delivery.
Image shown: High Magnification SEM shows chondrocyte attachment to collagen fibers
Every MACI implant undergoes rigorous release testing to confirm:
Viability
Verifies a sufficient amount of viable chondrocytes for implantation is available
Identity
Uses genetic markers to identify chondrocyte cells
Potency
Validating the ability to form a durable repair tissue
Sterility
Used throughout the process to detect most organisms within 48 hours*
*Sterility results are not available at the time of shipping.
References: 1. Pettit RJ, Everhart JS, DiBartola AC, Blackwell RE, Flanigan DC. Time matters: knee cartilage defect expansion and high-grade lesion formation while awaiting autologous chondrocyte implantation. Cartilage. 2021;13(suppl 2):1802S-1808S. 2. Flanigan DC, Sherman SL, Chilelli B, et al. Consensus on rehabilitation guidelines among orthopedic surgeons in the United States following use of third-generation articular cartilage repair (MACI) for treatment of knee cartilage lesions. Cartilage. 2021;13(suppl 1): 1782S-1790S. 3. Saris D, Price A, Widuchowski W, et al; SUMMIT study group. Matrix-applied characterized autologous cultured chondrocytes versus microfracture: two-year follow-up of a prospective randomized trial. Am J Sports Med. 2014;42(6):1384-1394. 4. Brittberg M, Recker D, Ilgenfritz J, Saris DBF; SUMMIT Extension Study Group. Matrix-applied characterized autologous cultured chondrocytes versus microfracture: five-year follow-up of a prospective randomized trial. Am J Sports Med. 2018;46(6):1343-1351. 5. Cherubino P, Grassi FA, Bulgheroni P, Ronga M. Autologous chondrocyte implantation using a bilayer collagen membrane: a preliminary report. J Orthop Surg (Hong Kong). 2003;11(1):10-15. 6. Gudeman AS, Hinckel BB, Oladeji L, et al. Evaluation of commercially available knee cartilage restoration techniques stratified by FDA approval pathway. Am J Sports Med. 2022;50(13):3598-3704. 7. Hadley CJ, Shi WJ, Murphy H, Tjoumakaris FP, Salvo JP, Freedman KB. The clinical evidence behind biologic therapies promoted at annual orthopaedic meetings: a systematic review. Arthroscopy. 2019;35(1):251-259.