Approaches for Effective Clinical Application of Stem Cell Transplantation

Current Transplantation Reports
E AtticoGraziella Pellegrini

Abstract

This review highlights problems related to translation of advanced therapy medicinal products (ATMPs) from bench to bedsite. Regenerative medicine within the current regulatory frame reveals common hitches in the course of development, translation, and clinical application. This paper suggests outlining a path from the few examples of successfully approved vs unsuccessful advanced therapies. In the multitude of ongoing studies, few of them achieved positive results with a final treatment available to patients; this result was possible due to multidisciplinary teams working together from the beginning of the development and during the hard route to standardization and clinical application. The root of success of an advanced therapy requires not only the inescapable scientific and biological knowledge but also requires several contributions as regulatory, ethical, medical, and bio-engineering expertise, from the real beginning. A strong scientific rationale and an integrated network of expertises would contribute to a successful investment of available resources in advanced therapy medicinal products and to a greater confidence in future medicine.

References

Mar 15, 2001·Proceedings of the National Academy of Sciences of the United States of America·G PellegriniM De Luca
Dec 31, 2002·Investigative Ophthalmology & Visual Science·Takahiro NakamuraShigeru Kinoshita
Sep 25, 2008·Molecular Therapy : the Journal of the American Society of Gene Therapy·Francesca Di NunzioFulvio Mavilio
Jan 31, 2009·The New England Journal of Medicine·Alessandro AiutiMaria-Grazia Roncarolo
Nov 17, 2009·The Journal of Urology·Guido BarbagliMassimo Lazzeri
Jun 25, 2010·The New England Journal of Medicine·Paolo RamaGraziella Pellegrini
Nov 20, 2014·Journal of Tissue Engineering and Regenerative Medicine·Dong Won HyunMee Kum Kim
Jun 9, 2015·The Keio Journal of Medicine·Eva M MurauerJohann W Bauer
Apr 20, 2016·Regenerative Medicine·Graziella PellegriniPaolo Rama
Jul 15, 2016·The Annals of Otology, Rhinology, and Laryngology·Tendy ChiangChristopher K Breuer
Jun 20, 2017·Molecular Therapy. Methods & Clinical Development·Yuka IgarashiMasafumi Onodera
Nov 17, 2017·Nature·Tobias HirschMichele De Luca
Dec 28, 2017·Stem Cells Translational Medicine·Graziella PellegriniMichele De Luca
May 1, 2018·Annals of Cardiothoracic Surgery·Brooks UdelsmanHarald C Ott
May 10, 2018·Journal of Orthopaedic Surgery and Research·B GurerC Yilmaz

❮ Previous
Next ❯

Citations

Jun 18, 2020·Dental Materials : Official Publication of the Academy of Dental Materials·Franziska EhlickeJan Hansmann

❮ Previous
Next ❯

Related Concepts

Related Feeds

Allogenic & Autologous Therapies

Allogenic therapies are generated in large batches from unrelated donor tissues such as bone marrow. In contrast, autologous therapies are manufactures as a single lot from the patient being treated. Here is the latest research on allogenic and autologous therapies.