A well tolerated core needle muscle biopsy process suitable for children and adults.

Introduction Serial muscle biopsies within clinical trials for Duchenne muscular dystrophy (DMD) are critical to document therapeutic responses. Less invasive means of sampling muscle are needed. Methods We analyzed a retrospective consecutive case-series cohort of vacuum-assisted core needle muscle biopsy procedures performed on healthy and dystrophic individuals at a single institution assessing for safety and reliability of obtaining sufficient high quality biopsy tissue for histologic assessment in adult and pediatric subjects. Results Of 471 muscle cores from 128 biopsy procedures, 377-550mg of total muscle tissue was obtained per procedure with mean core weight of 129mg (SD 25.1mg). All Biopsies were adequate for histological assessment. There were no significant adverse events. Discussion This core needle biopsy approach, when combined with improved sample processing, provides a safe means to consistently obtain muscle samples for diagnostic and clinical trial applications. This article is protected by copyright. All rights reserved.