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The purpose of this (Proof of Concept) PoC study is to assess safety, tolerability and preliminary efficacy of intra articular (i.a.) LNA043 in regenerating the articular cartilage of the knee at the donor sites of the autologous chondrocyte implantation (ACI) procedure, with a hyaline tissue, significantly more often than with placebo.
The purpose of this (Proof of Concept) PoC study is to assess safety, tolerability and preliminary efficacy of intra articular (i.a.) LNA043 in regenerating the articular cartilage of the knee at the donor sites of the autologous chondrocyte implantation (ACI) procedure, with a hyaline tissue, significantly more often than with placebo. The highest single safe dose of LNA043 of the First in Human CLNA043X2101 study will be used.
This is a non-confirmatory, patient and investigator blinded, randomized, placebo-controlled, parallel group, single dose study in patients with cartilage lesions undergoing autologous cartilage implantation (ACI). Approximately 22 patients will be enrolled in the study to allow 18 completers. Participants will be treated only on one occasion (Day 1) with a single i.a. injection that will be performed under arthroscopic visualization.
The primary efficacy variable, GAG content change and bi-layer collagen organization in the cartilage repair tissue at the donor sites based on 7T MRI at week 4, and key secondary endpoints, will be analyzed using a mixed model repeated measures (MMRM) analysis of variance model, including all timepoints, to compare treatment groups.
Knee Cartilage Lesion
LNA043, placebo to LNA043
Novartis Investigative Site
Published on BioPortfolio: 2017-11-14T01:46:10-0500
The purpose of this study is to assess the efficacy, safety and tolerability of multiple intra-articular (i.a.) injections of LNA043 over 4-weeks, in regenerating the articular surface in ...
The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes within a col...
The study is a randomized, prospective, multicenter, controlled clinical trial of the Episealer Knee System.The Episealer Knee System is intended for subjects with a focal femoral knee cho...
This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microf...
The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight...
The aim of this study was to identify the effect of cartilage lesion in the lateral compartment of the knee on the surgical outcome of medial open-wedge high tibial osteotomy (MOWHTO). A total of 172 ...
The purpose of the present study was to investigate the mid-term outcomes of a single-stage cell-based procedure in patients with knee focal symptomatic cartilage defects using matrix-induced culture-...
Almost nothing is known about the condition of the knee joints of multistage ultra-marathon (MSUM) runner. This is first image-based investigation of the femoropatellar joint (FPJ) using a mobile 1.5T...
Autologous chondrocyte implantation (ACI) and microfracture are two of the main surgical treatment options for articular cartilage lesions of the knee. Consensus regarding the best clinical options to...
Knee cartilage damage is often linked to mechanical overloading. However, cartilage requires mechanical load to remain healthy, suggesting that underloading may be detrimental. We examined knee overlo...
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.
A type of CARTILAGE characterized by a homogenous amorphous matrix containing predominately TYPE II COLLAGEN and ground substance. Hyaline cartilage is found in ARTICULAR CARTILAGE; LARYNGEAL CARTILAGES; and the NASAL SEPTUM.
A type of CARTILAGE whose matrix contains ELASTIC FIBERS and elastic lamellae, in addition to the normal components of HYALINE CARTILAGE matrix. Elastic cartilage is found in the EXTERNAL EAR; EUSTACHIAN TUBE; EPIGLOTTIS; and LARYNX.
A type of osteochondritis in which articular cartilage and associated bone becomes partially or totally detached to form joint loose bodies. Affects mainly the knee, ankle, and elbow joints.
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...