Biomedical Engineering Reference
In-Depth Information
17
Development of Human
Chondrocyte
-
Based Medicinal
Products for Autologous Cell Therapy
Livia Roseti
1
, Alessandra Bassi
1
, Brunella Grigolo
2
and
Pier Maria Fornasari
1
1
PROMETEO Laboratory;
2
RAMSES Laboratory
1,2
Rizzoli RIT (Research, Innovation & Technology),
Istituto Ortopedico Rizzoli, Bologna,
Italy
1. Introduction
A cell therapy is a clinical treatment including an
ex vivo
cell manipulation step. Such a
therapeutical option began more than forty years ago and is now a worldwide reality. Many
human cell-based clinical trials have been developed in every medicine's field mostly to
cure diseases where conventional treatments are inadequate. Even though there have been
few completed trials and some conflicting results on their effectiveness have been reported,
the full potential of cell-based treatments remains to be explored and investigated (Park et
al., 2008). Moreover, public expectation for such novel therapies, especially for treating
incurable and/or rare diseases, remains high. Nowadays each tissue of the human body,
including foetal and embryonic ones, can become a reliable source for cell therapy (Mason &
Dunnill, 2009). Cells isolated from a specific source can be used also to cure every other
tissue of the body and may be administered alone, in combination with biomaterials,
scaffolds, cytokines and growth factors or can be genetically manipulated (gene therapy).
Cell administrations can be local or systemic, singles or multiples. Treatments may be
autologous or allogeneic (from living or cadaver donors). A cell preparation can be crucial
for a treatment such as in bone marrow transplantation or otherwise it may be used as an
adjuvant to improve clinical results like in regenerative medicine or to slow down the
development of several chronic conditions. Cell effect after treatment can be via the ability
to differentiate along several lineages or, as recently highlighted for stem cells, also via the
capacity to release anti-inflammatory cytokines, growth factors and proteins, collectively
known as paracrine factors, which may modulate the host microenvironment by stimulating
endogenous stem cells recruitment, differentiation and angiogenesis, thus acting as real
drugs (Yagi et al., 2010).
Ex vivo
cell manipulation protocols are different, depending on cell
source, type, target, disease and Country regulations. Current European cell therapy laws
classify manipulation types according to potentially associated risks. Cutting, grinding,
shaping, centrifugation, soaking in antibiotic or antimicrobial solutions, sterilization,
irradiation, cell separation, concentration or purification, filtering, lyophilization, freezing,
cryopreservation and vitrification are considered “minimal manipulations”. On the other
