ANNUAL REPORT 2012 - TiGenix

are at the heart of the immunomodulatory
properties of eASCs. During the inflammatory
process, IFN-γ is secreted by the patient’s
lymphocytes. When eASCs are injected
into the inflamed site, they are activated by
the IFN-γ, resulting in the expression of the
enzyme IDO. The enzymatic activity of IDO
suppresses the proliferation of activated
lymphocytes, shutting down chronic
inflammation, and thereby supports a natural
healing of the inflamed tissue.
The second property of the eASC, secretion
of repair and growth promoting molecules,
is playing a role after the initial control of
inflammation like in fistula healing.
Expanded adipose tissue
as active ingredient
TiGenix has developed its platform using
expanded adipose stem cells (eASC)
extracted from human adipose tissue. By
sourcing cells from adult adipose (fat) tissue,
the company is able to capitalize on the
benefits associated with this type of cells
compared to other cell types (such as stem
cells sourced from bone marrow). The most
important advantages of this approach
are : ease and amount of supply (collected
through a routine liposuction); rich supply of
stem cells (stem cells can represent 2 % of the
total cells of the Stromal Vascular Fraction
(“SVF”) of the fat tissue; a potential yield of
100 to 1,000 times higher than other possible
sources of stem cells; robust phenotype
(eASCs do not require overly elaborate
growth conditions and can be grown
continuously without loss of their primary
characteristics); and a good safety profile.
Allogeneic approach
An allogeneic (based on donor cells)
treatment has a series of advantages when
compared to using autologous (based on
the patient’s own cells) cell products, such
as :
(a) Efficient production of large lots (batches)
of cells :
- Manufacturing scale-up can be applied
- Quality control tests can be applied to
larger lots, reducing cost of manufacturing
- Material of high consistency (individual lots
of a large batch)
(b) Cells are always available :
- Can address emergency indications
- Allows high patient throughput
- Represents a good commercial opportunity
(c) No patient biopsy/tissue procurement
needed :
- Less clinical time and resources
- Avoids taking biopsies from severely ill
patients
- Allow for treatment of patients who do not
possess sufficient tissue or who for any other
medical reason cannot undergo tissue
procurement
(d) Commercial product orientated :
- Readily-available product
60 TiGenix I annual report 2012
- Potentially higher margins thanks to
optimized product cost of goods