Toward cell therapy using placenta-derived cells: disease mechanisms, cell biology, preclinical studies, and regulatory aspects at the round table

Among the many cell types that may prove useful to regenerative medicine, mounting evidence suggests that human term placenta-derived cells will join the list of significant contributors. In making new cell therapy-based strategies a clinical reality, it is fundamental that no a priori claims are made regarding which cell source is preferable for a particular therapeutic application. Rather, ongoing comparisons of the potentiality and characteristics of cells from different sources should be made to promote constant improvement in cell therapies, and such comparisons will likely show that individually tailored cells can address disease-specific clinical needs. The principle underlying such an approach is resistance to the notion that comprehensive characterization of any cell type has been achieved, neither in terms of phenotype nor risks-to-benefits ratio. Tailoring cell therapy approaches to specific conditions also requires an understanding of basic disease mechanisms and close collaboration between translational researchers and clinicians, to identify current needs and shortcomings in existing treatments. To this end, the international workshop entitled "Placenta-derived stem cells for treatment of inflammatory diseases: moving toward clinical application" was held in Brescia, Italy, in March 2009, and aimed to harness an understanding of basic inflammatory mechanisms inherent in human diseases with updated findings regarding biological and therapeutic properties of human placenta-derived cells, with particular emphasis on their potential for treating inflammatory diseases. Finally, steps required to allow their future clinical application according to regulatory aspects including good manufacturing practice (GMP) were also considered. In September 2009, the International Placenta Stem Cell Society (IPLASS) was founded to help strengthen the research network in this field.

Quality control for retinal OCT in multiple sclerosis: validation of the OSCAR-IB criteria.

BACKGROUND Retinal optical coherence tomography (OCT) permits quantification of retinal layer atrophy relevant to assessment of neurodegeneration in multiple sclerosis (MS). Measurement artefacts may limit the use of OCT to MS research. OBJECTIVE An expert task force convened with the aim to provide guidance on the use of validated quality control (QC) criteria for the use of OCT in MS research and clinical trials. METHODS A prospective multi-centre (n = 13) study. Peripapillary ring scan QC rating of an OCT training set (n = 50) was followed by a test set (n = 50). Inter-rater agreement was calculated using kappa statistics. Results were discussed at a round table after the assessment had taken place. RESULTS The inter-rater QC agreement was substantial (kappa = 0.7). Disagreement was found highest for judging signal strength (kappa = 0.40). Future steps to resolve these issues were discussed. CONCLUSION Substantial agreement for QC assessment was achieved with aid of the OSCAR-IB criteria. The task force has developed a website for free online training and QC certification. The criteria may prove useful for future research and trials in MS using OCT as a secondary outcome measure in a multi-centre setting.

Siege und Niederlagen, Irrtümer und Erkenntnisse nach 30 Jahren Geschlechtergeschichte. Eine Bilanz

Die Geschlechtergeschichte blickt mittlerweile auf eine mehr als fünf Jahrzehnte überspannende Entwicklung zurück. Wenn Geschlechtergeschichte inzwischen auch bis in die Schulbücher und in die Einführungen zum Geschichtsstudium Eingang gefunden hat, nimmt sie im Fach dennoch weiterhin eine ambivalente Position ein: Sie war einerseits an wichtigen theoretischen Entwicklungen maßgeblich beteiligt (Alltagsgeschichte, historische Anthropologie, linguistic turn, cultural turn, postcolonial turn), andererseits haftet ihr bis heute der Ruch der politisch gefärbten und daher tendenziösen und „unsoliden“ Wissenschaft an. Im Panel soll es darum gehen, wichtige Stationen der Entwicklung der Geschlechtergeschichte (von der Frauen- zur Geschlechtergeschichte, von der feministischen zur akademischen Forschung, von der Etablierung zur Kritik der Kategorie Geschlecht, vom Um-Schreiben der Geschichte zur Historiographie der Geschlechtergeschichte usw.) nachzuvollziehen sowie die wichtigsten Erträge der geschlechtergeschichtlichen Forschung zu beleuchten und Felder zu benennen, in denen die geschlechtergeschichtliche Forschung die Geschichtswissenschaft insgesamt beeinflusst und verändert hat. Dies soll in zwei Etappen realisiert werden: Im ersten Panel sollen wichtige Leistungen der Geschlechtergeschichte innerhalb der Geschichtswissenschaft beleuchtet und deren Rezeption innerhalb der pluralisierten geschichtswissenschaftlichen Ansätze diskutiert werden. In einem zweiten Schritt sollen wichtige Entwicklungen innerhalb der Geschlechtergeschichte themen- bzw. problemspezifisch präsentiert und diskutiert werden. Dies soll in Form einer round table-Diskussion erfolgen. Dabei richtet sich der Blick v.a. auf den bundesdeutschen Raum, ohne aber internationale Entwicklungen dabei außer Acht zu lassen.

The floating mass transducer at the round window: direct transmission or bone conduction?

The round window placement of a floating mass transducer (FMT) is a new approach for coupling an implantable hearing system to the cochlea. We evaluated the vibration transfer to the cochlear fluids of an FMT placed at the round window (rwFMT) with special attention to the role of bone conduction. A posterior tympanotomy was performed on eleven ears of seven human whole head specimens. Several rwFMT setups were examined using laser Doppler vibrometry measurements at the stapes and the promontory. In three ears, the vibrations of a bone anchored hearing aid (BAHA) and an FMT fixed to the promontory (pFMT) were compared to explore the role of bone conduction. Vibration transmission to the measuring point at the stapes was best when the rwFMT was perpendicularly placed in the round window and underlayed with connective tissue. Fixation of the rwFMT to the round window exhibited significantly lower vibration transmission. Although measurable, bone conduction from the pFMT was much lower than that of the BAHA. Our results suggest that the rwFMT does not act as a small bone anchored hearing aid, but instead, acts as a direct vibratory stimulator of the round window membrane.

Factors improving the vibration transfer of the floating mass transducer at the round window

With the placement of a floating mass transducer (FMT) at the round window, a new approach of coupling an implantable hearing system to the cochlea has been introduced. The aim of the present experimental study is to examine the influence of different ways of FMT placement at the round window on the vibration energy transfer to the cochlea.