Regulatory Considerations Applicable to Manufacturing of Human Placenta-Derived Mesenchymal Stromal Cells (MSC) Used in Clinical Trials in Australia and Comparison to USA and European Regulatory Frameworks

Abstract

AbstractIndependent development of regulatory frameworks in Australia, Europe and the USA has led to differences in their regulatory approach to biologics (or biologicals). Some of these were favourable for the conduct of early clinical trials (i.e. TGA CTN and CTX). Others have been affected by external factors (i.e. UK membership in the EU) or have expanded their scope (i.e. CBER emergence within the FDA). Recently efforts have been made to harmonise the three frameworks via joint guidances to industry and researchers and memoranda of understanding and cooperation among the regulatory bodies from the regions. We present our own experience in manufacturing and use of human placenta-derived mesenchymal stromal cells (hpMSC) in phase 1 clinical trials conducted in Australia according to the new Biologicals Framework established by Therapeutic Goods Administration (TGA) as from 1 July 2011. We also present similarities and differences with some other regulatory frameworks (USA and EU) that may be of interest to us in the future.KeywordsMesenchymal stromal cellMSCPlacentaRegulatory requirementsBiologicals frameworkClinical trialsTGAFDAEMA