From basic endotoxin screens to flow cytometry, we procure devices and design models for clinically accessible characterization methods.
By definition, evidence-based regenerative medicine implies the characterization of platelet, cell, tissue and/or other patient-specific markers before, during and after therapy. Precisely what needs to be characterized depends on the biological mechanism of action scientifically presumed for a given indication, procedure, device and patient cohort. Indeed, a central activity of an RMCE is a clinically and scientifically legitimate approach to this characterization. This approach is, in turn, closely related to the design of appropriate observational protocols for all regenerative medicine procedures delivered by the center, and the maintenance of de-identified, aggregated registries for each such observational protocol.
A busy clinical setting rarely posesses the complex equipment of a research laboratory, nor the time or personnel to use such equipment. However, modern technology is quickly bringing down the cost and improving the convenience of cell counting and other approaches to characterization. Moreover, integral to each RMCE is a dedicated lab technician, whose responsibilities will include equipment calibration, cell/tissue characterization, assistance with procedures as requested by the clinician, data collection against observational protocols, engaging with patients and other HCP’s in the context of his/her responsibilities.