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ANNUAL REPORT 2012 - TiGenix

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Therapeutics (product Hyalograft C) and<br />

Cellmatrix in Scandinavia. Next to these<br />

companies, there are a number of hospitals<br />

that produce autologous cartilage for their<br />

own patients.<br />

6.5. PRODUCTS IN DEVELOPMENT :<br />

THE ADIPOSE DERIVED<br />

STEM CELL PLATFORM<br />

6.5.1. Products and technology<br />

Cell-free products<br />

Alternative competition may come from cellfree<br />

products that also target the cartilage<br />

repair market, but that will generally be<br />

brought to market through the medical<br />

device regulatory route. Several ACI<br />

companies such as BioTissue are considering<br />

abandoning the cell-based products, and<br />

are attempting to bring one-step, cell-free<br />

products to the market through the CE<br />

marking route in Europe. Examples of other<br />

competing products are AMIC (Geistlich), a<br />

collagen membrane used in combination<br />

with microfracture and BST-Cargel<br />

(Piramal) and GelrinC (Regentis) self-gelling<br />

products, also for use in combination with<br />

microfracture. Gelrin C is currently not for<br />

sale in Europe and US, but is expected to<br />

apply for CE mark in 2013 13 .<br />

For the treatment of osteochondral defects<br />

there are several solutions in the market.<br />

Kensey Nash is currently involved in a Phase<br />

II trial for an acellular osteochondral graft.<br />

The same company also markets Osseofit, an<br />

osteochondral scaffold. Similar scaffolds are<br />

offered by Smith & Nephew (TruFit), and Fin<br />

Ceramica (MaioRegen).<br />

<strong>TiGenix</strong>’s strategy is to exploit the recognized<br />

mechanism of action of expanded<br />

adipose-derived stem cells (“eASC”) in<br />

immune-mediated inflammatory processes<br />

and to develop groundbreaking allogeneic<br />

stem cell products for treating a broad range<br />

of inflammatory and autoimmune diseases.<br />

The Company’s current development<br />

programs are based on a proprietary<br />

technology platform of eASCs. The rationale<br />

for choosing eASCs as a highly competitive<br />

and next generation platform for future<br />

market opportunities in inflammatory and<br />

autoimmune diseases is outlined here below.<br />

Mechanism of action<br />

Two main biological mechanisms underlie<br />

the efficacy of stem cells in disease<br />

treatment : their anti-inflammatory<br />

properties, and their secretion of repair<br />

and growth promoting molecules. For the<br />

treatment of inflammatory and autoimmune<br />

diseases, the former property is thought to<br />

play the most fundamental role.<br />

Certain stem cell populations act as<br />

immunomodulatory agents by interacting<br />

with cells of the immune system. <strong>TiGenix</strong>’s<br />

scientists have been able to confirm that<br />

activation of eASCs by interferon-gamma<br />

(“IFN- ”) 14 , and the subsequent expression<br />

of tryptophan metabolizing enzyme<br />

Indoleamine 2,3 dioxygenase (“IDO”) 15<br />

11<br />

http ://clinicaltrials.gov/ct2/show/NCT01656902?term=novocart+3d&rank=1<br />

12<br />

http ://clinicaltrials.gov/ct2/show/NCT01222559?term=chondrosphere&rank=2<br />

13<br />

http ://medtechinsider.com/archives/28003<br />

14<br />

Best Pract Res Clin Haematol. 2011 Mar;24(1) :49-57. Epub 2011 Feb 23. “Mesenchymal stem cells and autoimmune diseases.”<br />

15<br />

Stem Cells Dev. 2008 Aug;17(4) :681-93.”Soluble factors-mediated immunomodulatory effects of canine adipose tissue-derived<br />

mesenchymal stem cells.” Kang JW, Kang KS, Koo HC, Park JR, Choi EW, Park YH.<br />

59

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