作者
James Mittra, Joyce Tait, Michelle Mastroeni, Marc L Turner, Joanne C Mountford, Kevin Bruce
发表日期
2015/1/25
期刊
New biotechnology
卷号
32
期号
1
页码范围
180-190
出版商
Elsevier
简介
Highlights
- We map the product development pathway for a novel cultured blood therapy.
- We highlight the role of methodological and regulatory innovation in future development in the field.
- We describe the regulatory and manufacturing challenges for regenerative medicine.
- We discuss broader lessons from this case study for successful translation of regenerative medicine more generally.
- The cultured blood therapy is a challenge for the current regulatory system.
The creation of red blood cells for the blood transfusion markets represents a highly innovative application of regenerative medicine with a medium term (5–10 year) prospect for first clinical studies. This article describes a case study analysis of a project to derive red blood cells from human embryonic stem cells, including the systemic challenges arising from (i) the selection of appropriate and viable regulatory protocols and (ii) technological constraints …
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J Mittra, J Tait, M Mastroeni, ML Turner, JC Mountford… - New biotechnology, 2015