Good Clinical Practices and Regulatory Aspects Concerning Cell Therapy Clinical Research

Bruna Zambonato, Nathan Buggs, Annelise Pezzi, Vanessa Valim, Alice Dahmer, Filipe Sehn, Ianae Wilke, Juliana Furlan, Maria Aparecida Lima da Silva, Bruna Amorin, Lucia Silla

Abstract: When it comes to clinical research, the Good Clinical Practice (GCP) quality standard not only protects the safety, well-being and rights of participants enrolled in clinical trials, but also ensures the validity and reliability of data and results generated. As cell therapy (CT) research expands, it is necessary that studies involving this subject be conducted with the same care and standards that clinical research, involving conventional drugs, are currently being conducted. Additionally, cell therapy must work in accordance with current Good Manufacturing Practice (GMP), in order to maintain the quality of its products. The goal of this study, an exploratory literature review conducted at CTC-HCPA, is to review and discuss the good clinical practices and regulatory aspects of cell therapy research. These aspects rely not only on following the current parameters of GCP and GMP but also on acting in accordance with the legislation implemented in each country where the studies take place. Further, several resources are also necessary to ensure the quality of research data and products, such as authorized facilities, equipment able to generate reliable results, and a multidisciplinary team with wide knowledge of GCP/GMP quality standards and pertinent legislation.

Keywords: Clinical Trial, Cell Therapy, Stem Cell, Protocols, Good Manufacturing Practices, Regulation, Law