Standard toxicity study of clinical-grade allogeneic human bone marrow-derived clonal mesenchymal stromal cells.

ABSTRACT:

Introduction

Mesenchymal stromal cells (MSCs) have opened a new window to treat inflammatory and non-inflammatory diseases. Nonetheless, their clinical applications require rigorous control and monitoring procedures to ensure full compliance with the principles of good manufacturing practice (GMP). Various evaluations should be passed in conjunction with the development of these newly emerging therapeutic products from bench-to-bedside. These evaluations include in vitro characterization, preclinical studies, and clinical trials to ensure product safety and efficacy. Therefore, a robust and well-designed preclinical study is critical to confirm product safety. This study aims to determine the probable toxicity effects of local and systemic injections of cryopreserved human bone mar

SUBMITTER: Tayebi B 

PROVIDER: S-EPMC9137136 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature