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OPEN ACCESS ARTICLE
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EDITORIAL |
Correspondence: Mahendra Rao, M.D., Ph.D. Invitrogen, 1620 Faraday Avenue, Carlsbad, California 92008, USA. Telephone: 240-379-4119 Fax: 410-510-1188 e-mail: mahendra.rao{at}invitrogen.com
Received April 27, 2007;
accepted for publication May 21, 2007.
INTRODUCTION
MSC or mesenchymal stem cells [1] are cells of the mesodermal lineage that can differentiate into a variety of lineages. Cells with overall similar properties have been isolated from diverse biological sources such as bone [2], skeletal muscle, lung, deciduous teeth [3], and human umbilical cord [4]. Due to the absence of a single definitive marker, MSC are generally characterized by the lack of markers expressed by other related stem cell populations and differentiated cells and the presence of a combination of markers. There is a consensus that MSC lack the common hematopoietic markers such as CD45, CD34, and CD14 [5], and express STRO-1, SH2, SH3, and SH4 [5–8].
Although the self-renewal capacity of MSC is thought to be limited, MSC can nevertheless be propagated in culture for 8–10 passages while retaining the phenotypic characteristics and differentiation ability. Given the relatively large numbers of MSC present in the adult, sufficient numbers of cells can be harvested from an average individual to serve autologous cell therapy. This relative ease of isolating cells and propagating them and the multitude of functions the MSC appear to perform have led to a relatively rapid rush to the clinic. MSC have been clinically used for treating children with osteogenesis imperfecta, to enhance hematopoietic recovery, and for bone tissue regeneration. An additional reported ability of MSC to modulate the immune response has led to their evaluation as an adjunct to bone marrow stem cells to enhance engraftment and for the reduction of graft-versus-host disease in mismatched transplants [9–11]. Other uses have been envisaged as well, including treatment of stroke, cardiac infarct, and as a component of skin grafts.
The large number of investigator-initiated studies, the necessity for propagating MSC in culture, and the extension of their use in allogenic situations has prompted the Food and Drug Administration to regulate MSC trials, much as they would any other investigational new drugs. These regulations as well as similar, although not identical, rules in the European Union have led to an alteration in the manner in which clinical trials can be initiated. Investigators have had to rapidly familiarize themselves with rules and regulations that the regulatory agencies are still in the process of formulating. These rules are also changing, as this is a new arena that the regulatory agencies are not very familiar with.
STEM CELLS, as the leading journal in the field of stem cell biology, felt that it was important to provide a forum for results related to this translational process from recent discovery to clinical application that MSC appear to be rapidly bridging. We have therefore invited investigators to submit their work in this exciting field to a special section on clinical and translational work on MSC. In addition, we have invited key leaders in the field to provide in-depth reviews and share their experiences in characterizing cells, scaling up production, testing and validating cells, and strategies for in vivo monitoring and clinical assessment. The Journal looks forward to helping catalyze discussion and enhancing the pace of progress in this dynamic field.
Invitrogen, Carlsbad, California, USA
REFERENCES
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