Second-look assessment after all-arthroscopic autologous chondrocyte implantation with spheroides at the knee joint

Siebold, Rainer; Karidakis, Georgios; Feil, Sven; Fernandez, Francis

doi:10.1007/s00167-015-3822-2

Cited by 23 publications

(28 citation statements)

References 36 publications

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“…Given the paucity of RCT data and the limitations of the NMA, the ERG looked to see if anything could be gleaned from case series. [15][16][17][18][19] However, these case series were mainly small, three were just pilot studies, two were available only as conference abstracts, and others have duration of only around a year. Without control groups, the value of these case series were deemed limited.…”

Section: Evidence From Indirect Treatment Comparisons or From Other Smentioning

confidence: 99%

Autologous Chondrocyte Implantation with Chondrosphere for Treating Articular Cartilage Defects in the Knee: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2018

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Section: Evidence From Indirect Treatment Comparisons or From Other Smentioning

confidence: 99%

Autologous Chondrocyte Implantation with Chondrosphere for Treating Articular Cartilage Defects in the Knee: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2018

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“…The initial efficacy of the product in terms of MRI morphological evaluation of repair tissue was recently published [11]. Furthermore, according to the ICRS-CRA (International Cartilage Repair Score, Cartilage Repair Assessment) and KOOS (Knee Injury and Osteoarthritis Outcome Score), good second-look arthroscopy and clinical results were found in a single-surgeon cohort study [12]. The objective of this paper is to present the safety results and thus to assess the safety of the three dose levels of the three-dimensional autologous chondrocyte implantation product ACT3D-CS in the treatment of cartilage defects (4–10 cm 2 ) of knee joints over a 36-month observation period.…”

Section: Introductionmentioning

confidence: 99%

Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial

Becher

Laute²,

Fickert

et al. 2017

J Orthop Surg Res

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BackgroundThis study was conducted to assess the efficacy and safety of the three dose levels of the three-dimensional autologous chondrocyte implantation product chondrosphere® in the treatment of cartilage defects (4–10 cm2) of knee joints. We hereby report the safety results for a 36-month post-treatment observation period.MethodsThis was a prospective phase II trial with a clinical intervention comprising biopsy for culturing spheroids and their subsequent administration (level of evidence: I). Patients’ knee defects were investigated by arthroscopy, and a cartilage biopsy was taken for culturing. Patients were randomised, on a single-blind basis, to treatment at the dose levels 3–7 (low), 10–30 (medium) or 40–70 (high) spheroids per square centimetre. Assessment (adverse events, vital signs, electrocardiography, physical examination, concomitant medication and laboratory values) took place 1.5, 3, 6, 12, 24 and 36 months after chondrocyte implantation.ResultsSeventy-five patients were included and 73 treated. The incidence of adverse events, of patients with adverse events and of patients with treatment-related adverse events showed no relevant difference between the treatment groups. There were no fatal adverse events, no adverse events led to premature withdrawal from the trial and none led to permanent sequelae. Two patients experienced serious adverse events considered related to the study treatment: arthralgia 2–3 years after implantation and chondropathy 1 and 2 years after implantation.ConclusionsThe treatment with chondrosphere® was generally well tolerated. No relationship was detected between any safety criteria and the dose level: Differences between the dose groups in the incidence of any adverse events, and in numbers of patients with treatment-related adverse events, were insubstantial.Trial registrationclinicaltrials.gov, NCT01225575.

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“…Good clinical results were also reported by Körsmeier et al 19 in 2016. Statistically significant increases of the subjective assessment scores were reported as early as 6 weeks after implantation, and second-look arthroscopy showed good ingrowth 34 70.9 b (n ¼ 30) Fickert (2012) 11 70.0 (n ¼ 37) Weighted average 74.5 (n ¼ 259) Tegner Siebold (2018) 34 5.0 (n ¼ 30) Siebold (2016) 33 3. 87.5 ± 10.0 (n ¼ 22)…”

Section: Act3d In the Hip Jointmentioning

confidence: 99%

“…The appearance of the repair tissue was found to resemble normal cartilage without significant differences to the corresponding healthy joint surface. 33,34 ACT3D further proved to be a suitable therapy for children and adolescents with chondral defects. 14 In 2020, Niemeyer et al 29 published the 4-year outcomes of their European Medicines Agency (EMA)-driven, prospective, phase II study addressing the dose-dependent safety and efficacy of Chondrosphere.…”

Section: Act3d In the Knee Jointmentioning

confidence: 99%

“…Hoburg (2019) adults 14 92.9 ± 7.9 (n ¼ 30) Siebold (2018) 34 77.7 ± 14.6 (n ¼ 30) Siebold (2016) 33 79.0 ± 18.0 (n ¼ 31) Fickert (2012) 11 82. 34 84.2 ± 5.6 (n ¼ 30) Siebold (2016) 33 63.0 ± 18.8 (n ¼ 31) Fickert (2012) 11 64.0 (n ¼ 37) Weighted average 73.5 (n ¼ 147) KOOS (overall) Hoburg (2020) 15,28 83.2 ± 14.9 (n ¼ 48) Niemeyer (2020) 5,27,29 77. 34 used a maximum MOCART score of 85 rather than 100; to compare their results with those of the other studies, we used the percentage instead of the absolute value.…”

Section: Act3d In the Hip Jointmentioning

confidence: 99%

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Three-dimensional, Scaffold-Free, Autologous Chondrocyte Transplantation: A Systematic Review

Riedl¹,

Vadalà

Papalia

et al. 2020

Orthopaedic Journal of Sports Medicine

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Background: A 3-dimensional, scaffold-free, and completely autologous form of chondrocyte transplantation (ACT3D) has been developed and applied in clinical practice in the past decade to overcome disadvantages of previous-generation procedures. Purpose: To document and analyze the available literature on the results of ACT3D in the treatment of articular chondral lesions in the knee and hip joints. Study Design: Systematic review; Level of evidence, 4. Methods: All studies published in English addressing ACT3D were identified and included those that fulfilled the following criteria: (1) level 1 through 4 evidence, (2) measures of radiological or functional/clinical outcome, and (3) outcome related to cartilage lesions of the knee and hip joints. Results: A total of 10 studies were selected: 2 randomized controlled trials, 1 cohort study, and 7 case series. The studies revealed significant increases in patients’ subjective quality of life, satisfaction, pain reduction, and improvement in joint function at short- to medium-term follow-up. Magnetic resonance imaging-assisted examination and second-look arthroscopy showed a hyaline-like repair tissue with a high degree of defect filling and integration. Conclusion: ACT3D shows promising results in the therapy of articular cartilage defects in the knee as well as in the hip, but well-designed, long-term studies are lacking. ACT3D might have relevant advantages over common matrix-associated autologous chondrocyte transplantation products, but systematic evaluation and randomized controlled studies are crucial to verify the potential of this tissue-engineered approach.

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Second-look assessment after all-arthroscopic autologous chondrocyte implantation with spheroides at the knee joint

Abstract: IV.

Cited by 23 publications

References 36 publications

Autologous Chondrocyte Implantation with Chondrosphere for Treating Articular Cartilage Defects in the Knee: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Autologous Chondrocyte Implantation with Chondrosphere for Treating Articular Cartilage Defects in the Knee: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial

Three-dimensional, Scaffold-Free, Autologous Chondrocyte Transplantation: A Systematic Review

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