Points to consider in designing mesenchymal stem cell-based clinical trials

Brooke, G., Rossetti, T., Ilic, N., Murray, P., Hancock, S., Pelekanos, R. and Atkinson, K. (2008) Points to consider in designing mesenchymal stem cell-based clinical trials. Transfusion Medicine and Hemotherapy, 35 4: 279-284. doi:10.1159/000143158


Author Brooke, G.
Rossetti, T.
Ilic, N.
Murray, P.
Hancock, S.
Pelekanos, R.
Atkinson, K.
Title Points to consider in designing mesenchymal stem cell-based clinical trials
Journal name Transfusion Medicine and Hemotherapy   Check publisher's open access policy
ISSN 1660-3796
Publication date 2008-08-01
Year available 2008
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1159/000143158
Open Access Status Not yet assessed
Volume 35
Issue 4
Start page 279
End page 284
Total pages 6
Place of publication Basel Switzerland
Publisher Karger
Language eng
Subject C1
970106 Expanding Knowledge in the Biological Sciences
970111 Expanding Knowledge in the Medical and Health Sciences
119999 Medical and Health Sciences not elsewhere classified
Abstract Therapeutic applications of cells are likely to increase greatly in the future. Cell and cell-based gene therapy manufacturing facilities need to be purpose-designed and accredited by their national medicinal regulatory body. Production scientists need to work in close tandem with quality assurance and ethics committees to absolutely ensure the safety of new cellular products. In this review, we consider the need for preclinical safety and efficacy data, tissue source for manufacture of clinical grade human mesenchymal stem cells, aseptic tissue processing, indemnification, and the role of the national medicinal regulatory body in appropriate clinical trial design.
Keyword Mesenchymal Stem Cells
MSC
Cell Therapies
Good Manufacturing Practice
clinical trials
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: 2009 Higher Education Research Data Collection
School of Medicine Publications
 
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Created: Wed, 08 Apr 2009, 23:20:58 EST by Joanne PRESTON on behalf of School of Medicine