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

ABSTRACT:

Background

This 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.

Methods

This 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. Asse

SUBMITTER: Becher C 

PROVIDER: S-EPMC5429514 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature