Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Mesenchymal Stem Cells Therapies Approved by Regulatory Agencies Around the World

Version 1 : Received: 14 April 2023 / Approved: 14 April 2023 / Online: 14 April 2023 (03:16:41 CEST)

A peer-reviewed article of this Preprint also exists.

Fernández-Garza, L.E.; Barrera-Barrera, S.A.; Barrera-Saldaña, H.A. Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World. Pharmaceuticals 2023, 16, 1334. Fernández-Garza, L.E.; Barrera-Barrera, S.A.; Barrera-Saldaña, H.A. Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World. Pharmaceuticals 2023, 16, 1334.

Abstract

Cell therapy has used mesenchymal stem cells (MSCs) which in cell culture are multipotent progenitors, capable of producing a variety of cells limited to the mesoderm layer. There are two types of MSCs sources: 1) adult MSCs, which are obtained from the bone marrow, adipose tissue, peripheral blood, and dental pulp; and 2) neonatal tissue-derived MSCs, obtained from extra-embryonic tissues such as the placenta, amnion, and umbilical cord. Until April 2023, there are 1,120 registered clinical trials using MSCs therapies worldwide, but there are only 12 MSCs therapies that have been approved by regulatory agencies for commercialization. Nine of the twelve approved MSCs products are from Asia, with South Korea being the country with the most approved therapies. In the future, MSCs will play an important role in the treatment of many diseases. However, there are many issues to deal with before their application and usage in medical practice. Some strategies have been proposed to face these problems with the hope of reaching the objective of applying these MSCs therapies at optimal therapeutic levels.

Keywords

Mesenchymal stem cells; Approved therapies; Cell therapy medical products; Regulatory agencies.

Subject

Medicine and Pharmacology, Medicine and Pharmacology

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