Balancing Safety and Efficacy With Early Availability in the Regulation of Regenerative Medicine Product

2020 ◽  
Author(s):  
Yasuhiro Fujiwara ◽  
Yoshiaki Maruyama ◽  
Futaba Honda
Keyword(s):  
Regenerative Medicine ◽  
Safety And Efficacy ◽  
Medicine Product

Considerations for Tissue-Engineered and Regenerative Medicine Product Development Prior to Clinical Trials in the United States

2010 ◽  
Vol 16 (1) ◽  
pp. 41-54 ◽  
Author(s):  
Mark H. Lee ◽  
Judith A. Arcidiacono ◽  
Anastacia M. Bilek ◽  
Jeremiah J. Wille ◽  
Caitilin A. Hamill ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Regenerative Medicine ◽  
Product Development ◽  
The United States ◽  
Medicine Product

scholarly journals The Role of Animal Models in Evaluating Reasonable Safety and Efficacy for Human Trials of Cell-Based Interventions for Neurologic Conditions

2008 ◽  
Vol 29 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Alan Regenberg ◽  
Debra JH Mathews ◽  
David M Blass ◽  
Hilary Bok ◽  
Joseph T Coyle ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Animal Models ◽  
Regenerative Medicine ◽  
Therapeutic Agents ◽  
Preclinical Studies ◽  
Safety And Efficacy ◽  
Proper Role ◽  
New Treatments ◽  
Gathering Data

Progress in regenerative medicine seems likely to produce new treatments for neurologic conditions that use human cells as therapeutic agents; at least one trial for such an intervention is already under way. The development of cell-based interventions for neurologic conditions (CBI-NCs) will likely include preclinical studies using animals as models for humans with conditions of interest. This paper explores predictive validity challenges and the proper role for animal models in developing CBI-NCs. In spite of limitations, animal models are and will remain an essential tool for gathering data in advance of first-in-human clinical trials. The goal of this paper is to provide a realistic lens for viewing the role of animal models in the context of CBI-NCs and to provide recommendations for moving forward through this challenging terrain.

Regenerative medicine therapies for sacroiliac joint disease

2021 ◽  
pp. 95-114
Author(s):  
Natalie H. Strand ◽  
Jillian Maloney ◽  
Christine L. Hunt
Keyword(s):  
Regenerative Medicine ◽  
Sacroiliac Joint ◽  
Platelet Rich Plasma ◽  
Mechanisms Of Action ◽  
Joint Disease ◽  
Published Data ◽  
Pain Medicine ◽  
Common Cause ◽  
Safety And Efficacy ◽  
Autologous Whole Blood

The sacroiliac joint is a common cause of low back pain, and techniques to reduce pain and improve function are of utmost interest to the pain medicine practitioner. As regenerative medicine continues to expand, a thorough understanding of the types of therapies that make up the regenerative medicine toolkit is imperative. This chapter reviews prolotherapy and injections of mesenchymal stem cells, platelet-rich plasma, autologous whole blood, and hyaluronic acid for the treatment of sacroiliac joint–mediated pain. Information on background, mechanisms of action, pharmacology, safety and efficacy, possible side effects, and preparation and administration is provided for each of these regenerative injectants, along with a brief review of clinical trials and published data.

Challenges in Tissue Engineering and Regenerative Medicine Product Commercialization: Building an Industry

2011 ◽  
Vol 17 (1-2) ◽  
pp. 1-3 ◽  
Author(s):  
Kiki B. Hellman ◽  
Peter C. Johnson ◽  
Timothy A. Bertram ◽  
Bill Tawil
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Medicine Product
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