Jornal de Histologia Molecular e Fisiologia Médica

Overcoming Clinical and Regulatory Hurdles in Mesodermal Stem Cell Therapy

Abstract

Azura Crencia

Clinical trials in mesodermal stem cell therapy encounter hurdles such as establishing standardized protocols, ensuring patient safety, and demonstrating long-term efficacy. Additionally, the regulatory environment is fraught with difficulties, including navigating evolving guidelines, securing approval for novel therapies, and addressing ethical concerns. These factors collectively impact the pace at which promising therapies can be validated and made available to patients. Mesodermal Stem Cell (MSC) therapy holds promise for treating various diseases due to their immune modulatory and regenerative properties. However, its clinical translation faces significant regulatory challenges. This abstract explores the current landscape of clinical trials involving MSC therapy, highlighting regulatory hurdles such as standardization of protocols, safety concerns and ethical considerations.