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Study on Safety, Tolerability Prelimenary Efficacy of LNA043 in Patients Undergoing Autologous Chondrocyte Implantation

2017-11-14 01:46:10 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Knee Cartilage Lesion

Intervention

LNA043, placebo to LNA043

Location

Novartis Investigative Site
Wien
Austria
1090

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-11-14T01:46:10-0500

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