or reconstruction of complex tissues and
organs. Therefore, regenerative engineering
can be viewed as the field that aims to
readily enable regenerative medicine so
that it can become a practical option for
the patient. Due to the involvement of
advances in materials science such as
nanotechnology and smart biomaterials to
help guide or diagnose tissue regeneration
and function, regenerative engineers will
face many difficulties, the largest
being the regulatory path that
must be navigated
companies to make
available to the end user.
The regulatory path
dictates the expected
safety, efficacy, and
cost that it will take to
implement these next-
products in the clinic.
A complex solution that
involves cells, biologics
(proteins or DNA),
and new materials will
lead to a more complicated regulatory path.
Nevertheless, in the foreseeable future, new
materials will be an essential component to
the goal of tissue regeneration.
Developing the right biomaterials
Biomaterials for regenerative engineering
can come in many compositions and forms.
They are generally used as a biodegradable
three-dimensional scaffold to guide or
inform the regenerative process. They
must also be amenable to the handling
characteristics that are required by the
surgeon to implant or deliver the product.
Biomaterials must also meet the quality
systems requirements for manufacturing
medical devices. Despite the
plethora of biomaterials
that are reported in
literature, the vast majority of biodegradable
medical products that are on the market are
based on decades-old polymer technology
that was originally introduced to fabricate
biodegradable or resorbable sutures—
namely lactide or glycolide-based polymers.
This is due to the need for companies to
be as conservative as possible to facilitate
the regulatory approval of new products
and reduce costs. Natural tissues that have
been processed to remove constituent
cells or other components have also
come to market. However, many of these
currently used materials do not provide the
properties or requirements that regenerative
engineering demand. Examples of how
the development of new biomaterials with
advanced functionality can impact the field
of regenerative engineering and regenerative
medicine are described below.
As most tissues and organs in the
body are elastic and it is now
recognized that cells and
tissues respond to
Regenerative engineering will require very close collaborations among scientists and
engineers from several fields. Credit: Guillermo Ameer.