scholarly journals Use of MACI (Autologous Cultured Chondrocytes on Porcine Collagen Membrane) in the United States: Preliminary Experience

2020 ◽  
Vol 8 (8) ◽  
pp. 232596712094181
Author(s):  
James L. Carey ◽  
Ann E. Remmers ◽  
David C. Flanigan

Background: In December 2016, MACI (autologous cultured chondrocytes on porcine collagen membrane) received approval from the US Food and Drug Administration for the treatment of symptomatic articular cartilage defects of the knee with or without bone involvement in adults. Purpose: To describe the cartilage defects and patient characteristics for 1000 adult patients treated with MACI for knee cartilage repair in the United States. Study Design: Case series; Level of evidence, 4. Methods: Data collected by Vericel for adult patients treated for articular cartilage defects of the knee were reconciled and summarized. Data were collected for 1000 consecutive patients starting on July 1, 2017, when Carticel (the prior generation of autologous cultured chondrocytes) was no longer available. Patient names were removed for confidentiality, and patients were identified by MACI lot number and surgery date. Safety data were derived from the pharmacovigilance database. Patient demographics, cartilage defect characteristics, concomitant surgical procedures, and adverse events were summarized with descriptive statistics. Results: A total of 1000 adults and 1010 knee joints were implanted with MACI by 372 surgeons. The male (49.6%)-to-female (50.4%) ratio was evenly split, and the mean age was 34.0 years. The majority of patients (68.1%) had a single cartilage defect treated, and the mean treated defect size was 4.7 cm2. The mean total treated lesion size, including multiple defects, was 5.8 cm2. The patella was the most commonly treated joint surface (32.7%), followed by the medial femoral condyle (31.3%). Most patients (92.4%) had concomitant surgical procedures at the time of cartilage biopsy acquisition. The most common concomitant procedures at the time of biopsy procurement included cartilage debridement (83.7%) and meniscal resection (11.3%). The most common planned concomitant surgeries at the time of MACI implantation were anterior tibial tubercleplasty (7.8%) and reconstruction of dislocating patella (5.5%). Few patients (2.6%) had adverse events. Conclusion: Patient age and mean total MACI-treated defect size in the United States are similar to the findings of the pivotal European SUMMIT (Superiority of MACI Implant Versus Microfracture Treatment) trial and other studies from outside the United States. Treatment of multiple cartilage defects is more frequent in the United States than elsewhere.

2013 ◽  
Vol 22 (9) ◽  
pp. 2070-2075 ◽  
Author(s):  
Scott R. Montgomery ◽  
Brock D. Foster ◽  
Stephanie S. Ngo ◽  
Rodney D. Terrell ◽  
Jeffrey C. Wang ◽  
...  

2004 ◽  
Vol 2 (4) ◽  
pp. 0-0
Author(s):  
Rimtautas Gudas ◽  
Romas Jonas Kalesinskas ◽  
Giedrius Bernotavičius ◽  
Eglė Monastyreckienė ◽  
Angelija Valančiūtė ◽  
...  

Rimtautas Gudas1, Romas Jonas Kalesinskas1, Giedrius Bernotavičius1, Eglė Monastyreckienė2, Angelija Valančiūtė3, Darius Pranys41 Kauno medicinos universiteto klinikųOrtopedijos ir traumatologijos klinikaEivenių g. 2, LT-50009 Kaunasel paštas: [email protected] Kauno medicinos universiteto klinikųRadiologijos klinika3 Kauno medicinos universitetoEmbriologijos ir histologijos katedra4 Kauno medicinos universitetoPatologinės anatomijos klinika Tikslas Mūsų prospektyvaus klinikinio tyrimo tikslas – įvertinti mozaikinės autologinės transplantacijos rezultatus gydant kelio sąnario kremzlės pažeidimus. Ligoniai ir metodai 1998–2002 metais KMU Ortopedijos ir traumatologijos klinikoje atliktos 87 autologinės mozaikinės transplantacijos operacijos esant kelio sąnario kremzlės ir kaulo pažeidimams. Pacientų amžiaus vidurkis operacijų metu buvo 24,74 ± 7,20 metų (14–40 metų). Simptomai vidutiniškai truko 21,32 ± 5,57 mėnesio, o pacientai įvertinti praėjus vidutiniškai 24,4 mėnesio (nuo 12 iki 60 mėnesių) po operacijos. Rezultatai apibendrinti naudojant ICRS (International Cartilage Repair Society) anketą, 13 (15%) atvejų – remiantis kartotinių artroskopijų metu atliktu makroskopiniu įvertinimu, 9 (11%) atvejais – histologiniu tyrimu, 57 (67%) atvejais – BMR ir visais atvejais – rentgeno tyrimais. Visus anketinius įvertinimus atliko nepriklausomas gydytojas ortopedas prieš operacijas ir po operacijų praėjus dvylikai, dvidešimt keturiems, trisdešimt šešiems, keturiasdešimt aštuoniems ir šešiasdešimčiai mėnesių. Nepriklausomi nuo tyrimo gydytojai, radiologas ir patologas, atliko visus BMR ir histomorfologinius įvertinimus. Rezultatai Praėjus vidutiniškai 24,4 mėnesio po mozaikinės transplantacijos, ICRS anketos būdu nustatytas klinikinis rezultatų pagerėjimas (p < 0,05). Funkcinis ir objektyvus įvertinimas pagal ICRS anketą buvo toks: 93% atvejų gauti geri ir labai geri operacinio gydymo rezultatai, kitais atvejais (7%) gydymo rezultatai buvo patenkinami. Kartotinių artroskopijų metu (remiantis ICRS protokolu), po operacijų praėjus vidutiniškai 12,4 mėnesio, 11 (84%) iš 13 atvejų buvo nustatytas geras ir labai geras sąnario kremzlės makroskopinis atsitaisymas. Sąnario kremzlės biopsijos ir histologinis tyrimas buvo atliktas 11% pacientų, ir daugumos jų (remiantis ICRS protokolu) sąnario kremzlės ir pokremzlinio kaulo atitaisymo koeficientas buvo geras. BMR tyrimas parodė, kad 94% pacientų sąnario paviršius atkurtas gerai arba labai gerai. Išvados Mūsų tyrimas parodė, kad po mozaikinės autologinės transplantacijos praėjus vidutiniškai 24,4 mėnesio (nuo 12 iki 60 mėn.) fiziškai aktyvių pacientų, kuriems buvo pažeista kelio sąnario kremzlė, klinikinė ir funkcinė būklė labai pagerėjo. Dauguma pacientų po kremzlės mozaikinės autologinės transplantacijos atgauna prieš pažeidimą buvusį fizinio aktyvumo lygį. Histomorfologinis persodintų transplantatų tyrimas parodė, kad visais tirtais atvejais išsilaikė hialininės kremzlės struktūra ir fibroelastinio audinio intarpai tarp transplantatų. Reikšminiai žodžiai: sąnario kremzlės pažeidimai, mozaikinė transplantacija Mosaic-like autologous osteochondral transplantation for the treatment of knee joint articular cartilage injuries Rimtautas Gudas1, Romas Jonas Kalesinskas1, Giedrius Bernotavičius1, Eglė Monastyreckienė2, Angelija Valančiūtė3, Darius Pranys4 Objective The purpose of this prospective clinical study was to evaluate the outcomes of mosaic type autologous osteochondral transplantation procedure for the treatment of the articular cartilage defects of the knee joint. Patients and methods Between 1998 and 2002, a total of 85 patients underwent an osteochondral autologous transplantation (mosaicplasty) procedure for osteochondral or chondral knee joint injury. The patients were evaluated using the ICRS score, arthroscopically, histologically, with MRI and X-ray examinations. The mean duration of symptoms was 21.32 ± 5.57 months and the mean follow-up was 24.4 months (range, 12 to 60 months). The mean age of the patients during the surgery was 24.74 ± 7.20 years (range, 14 to 40 years). An independent observer performed a follow-up examination after six, twelve, twenty-four, thirty-six and forty-eight months. In 13 (15%) of 85 cases 12.4 months postoperatively, arthroscopy with biopsy for histological evaluation was carried out. A radiologist and a pathologist, both blinded to each patient’s treatment, did the radiological and histological evaluations. Results After 24.4 months all the patients showed a significant clinical improvement (p < 0.05). The cartilage Repair Society (ICRS) score, functional and objective assessment revealed 93% to have excellent or good results after mosaicplasty; 7% were fair 24.4 months (range, 12–60 months) after the operations. The ICRS evaluation showed a significant improvement after the mosaicplasty procedure 24.4 months following operations (p = 0.005). No serious complications were reported. The ICRS for macroscopic evaluation during arthroscopy 12.4 months after mosaicplasty demonstrated excellent or good repair in 11 (84%) of 13 cases. Biopsy specimens were obtained from 9 (69%) of 13 patients, and histological evaluation of repair showed good scores (according to ICRS) for most samples after mosaicplasty. A MRI evaluation demonstrated excellent or good repairs in 94% after mosaicplasty. Conclusions On an average after 24.4 months (range, 12 to 60 months) of follow-up, our clinical study has shown a significant improvement of the clinical status of the physically active patients after the mosaic type autologous osteochondral transplantation for the repair of articular cartilage defects in the knee. Histologically, the osteochondral cylinder transplants retained hyaline cartilage. Keywords: articular cartilage injury, osteochondral mosaic-like transplantation


1996 ◽  
Vol 326 ◽  
pp. 270-283 ◽  
Author(s):  
Mats Brittberg ◽  
Anders Nilsson ◽  
Anders Lindahl ◽  
Claes Ohlsson ◽  
Lars Peterson

2000 ◽  
Vol 120 (3-4) ◽  
pp. 121-127 ◽  
Author(s):  
K. Katsube ◽  
M. Ochi ◽  
Y. Uchio ◽  
S. Maniwa ◽  
M. Matsusaki ◽  
...  

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