Abstract
Cell therapy in medicine elicits equal jubilation and pessimism. The notion that the diseased or aging cell can be replaced with a healthy cell, in particular the use of a pluripotent stem cell, has challenged the dogma of the nonregenerative status of mature cells. To this end, a long list of new stem cell sources has emerged, including those derived from the embryo, fetus, umbilical cord, placenta, amnion, bone marrow, adipose, skin, and menstrual blood. The derivation of a patient-specific set of stem cells is key to the success of cell medicine. However, the inadvertent entry of cell therapy into the clinic in the absence of solid scientific evidence, clinical guidance, and regulatory oversight has seriously hampered the realization of the true potential of cell medicine. Indeed, “stem cell tourism” has become an international business enterprise that has put the patient in unregulated medical treatment (see 2008 Guidelines for the Clinical Translation of Stem Cells, International Society for Stem Cell Research; www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf).
We recognize the need to expedite the translation of laboratory findings into clinical application, in view of the debilitating and many times fatal human disorders that may benefit from cell medicine. Accordingly, we sought a platform wherein the three important translational research components—namely the academic institution, the biomedical company, and the regulatory agencies—have an equal footing in providing a critical input on the science, as well as the safety and efficacy of this therapy. A careful examination of currently available journals reveals that there exists a limited open access communication among these three translational research components, in that most of the peer-reviewed journals cater to research experiments from the academicians, with an increasing number of studies conducted under a translational theme whereby a collaborative effort between a university and a biomedical company is apparent. In addition, many professional societies, such as the Cell Transplant Society and American Society for Neural Therapy and Repair, have been equally keen in forging ahead with translational medicine, and are yearning for a translational journal that publishes peer-reviewed proceedings and papers arising from their annual meetings. More unfortunate is that many experimental data from the biomedical companies, as well as the clinical guidelines issued by the regulatory agencies, appear as in-house or interagency manifestos. In our desire to advance cell medicine to the clinic, we embark on adding a new part to the established journal Cell Transplantation as Cell Medicine: Cell Transplantation Part B. Along the line of promoting the theme of translational research, we will build an Editorial Board consisting of academicians, biomedical experts, and regulatory administrators, who are specifically engaged in the science and translation of a cell product emerging from the laboratory to the clinic. Thus, Part B will allow Cell Transplantation to significantly increase its Editorial Board affiliation. Our overarching goal is to solicit and process, under rigorous, but fair and rapid peer review, those papers on cell therapy with direct clinical relevance. We are aware that translational studies are “milestone-driven” as opposed to routinely “mechanism-driven” experiments; thus, this further distinguishes our journal as we understand the difficulty in getting published in regular journals with strong emphasis on the latter aspect of scientific investigation. Moreover, we propose that an editorial commentary from the assigned handling editor to accompany many outstanding articles in order to outline the next steps necessary for the transition of the study under investigation closer to clinical application. We envision that this unique journal will facilitate the critical evaluation of cell medicine as a safe and an effective treatment for human disorders.
Cell Medicine will be an online-only journal, with focused articles on translational research from professional societies as well as collaborations among academia, industry, and/or regulatory agencies. For each online issue, the abstracts will be published in Cell Transplantation in a special “Cell Medicine Online” section.
This new initiative is in tandem with the “Open Access” format that was introduced in 2009. Both these changes are driven by our goal to make Cell Transplantation the journal of choice that caters to rapidly changing technology in dissemination of scientific knowledge and to the current push for translational research in the field of cell transplantation.