Biomedical Engineering Reference
In-Depth Information
(Baxter, 2003) and thereby is a viable method for reducing morbidity in high-risk
patients (Gamboa-Bobadilla, 2006).
10.6 Future trends
After preserving life, the ultimate goal of clinicians is to provide treatment that
restores natural structure, function and physiology irrespective of the pathology
source, be it acute or chronic, induced or traumatic, local or systemic, genetic or
acquired. The growing acceptance of RTMs for use in the repair of soft tissue
defects is being driven by the recognition of the overall RTM concept and by
clinical need. The studies described herein demonstrate that an intact natural RTM
has the ability to support intrinsic regenerative healing and the characterization of
these materials is providing insight into the roles that the underlying composition
and architecture may play in this process. Continued successful clinical outcomes
are likely to support expanded utility and application of the native RTM. Further
research on the mechanisms of wound healing and the factors that induce specific
functions may support the development of novel functionalized matrices that are
designed to elicit more specified healing responses or even to deliver specific
molecules that influence stem cell differentiation, direct the synthesis of particular
ECM molecules, provide antimicrobial properties, or support accelerated
hemostatsis.
By incorporating supporting materials such as bioabsorbable polymers, the
mechanical attributes of the ECM might be tailored leading to even broader
application of ECM scaffolds. While the RTM supports biological revitalization,
the mechanical properties are such that overloading of the structure is likely to
occur in environments requiring significant loading, such as is seen in ligament
and tendon. Providing an absorbable material with mechanical support while the
RTM undergoes biological transition poses the opportunity to engender a com-
pletely biological repair in a mechanically challenging environment. Similarly,
polymeric materials might be combined with particulate RTM to create unique
three-dimensional structures supportive of regenerative responses. Such hybrid
devices may find utility in soft tissue orthopaedics and cardiovascular applications.
Devices manufactured in part from acellular RTM are likely to be regulated by
the FDA as 510(k) or PMA devices. As such, sterility is expected. Many methods
of sterilization have been attempted, but they universally impart some modifica-
tions to the matrix structure. These modifications typically translate into reduced
biological function and may result in inducing a pathological response. Although
sterilization is not a direct advance in acellular RTM
per se
, advanced technologies
that better support matrix sterilization with the retention of biological performance
and the RTM's ability to elicit a regenerative response would be considered a
significant development in the field.
Finally, and most significantly, in the context of cutaneous wound healing,
continued characterization of novel RTMs and the manner in which the compris-
