Leuven, Belgium
Leuven, Belgium

TiGenix is a leading European cell therapy company with a proprietary validated allogeneic expanded adipose-derived stem cell platform technology for the treatment of autoimmune and inflammatory diseases, and a commercialised product. Its corporate headquarters are in Leuven, Belgium, and it has operations in Madrid, Spain. TiGenix was founded in 2000 by Prof. Dr. Frank P. Luyten and Gil Beyen as a spin-off from the Katholieke Universiteit Leuven and the Universiteit Gent.Built on solid pre-clinical and CMC packages, new stem cell products are being developed in close consultation with the European Medicines Agency . Cx601 is in Phase III of clinical development to treat complex perianal fistulas in patients with Crohn’s disease. Cx611 has successfully concluded a Phase IIa trial in rheumatoid arthritis, and is now in development for early rheumatoid arthritis and for severe sepsis.The company’s commercialised product, ChondroCelect®, an autologous cell therapy product for cartilage repair in the knee, was the first Advanced Therapy Medicinal Product to be approved by the European Medicines Agency , and is marketed and distributed by Swedish Orphan Biovitrum AB and by Red Cross Blood Systems in Finland.Cell Therapy and TigenixAfter small molecules and large molecules , cell and gene therapy are the next wave of medicinal therapy development. Cell therapy is distinctive and promising for addressing unmet medical needs because it can be regenerative, that is it repairs and replaces tissue and organs which are damaged; and it can be immune-modulatory, that is it controls inflammation and can help the body to return to homeostasis . Tigenix is at the forefront of this new wave, with a marketed product and a pipeline of late stage assets. The pipeline is developed from the eASC platform, an allogeneic cell therapy model whose products are scalable and ready for use. Wikipedia.

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The present invention provides methods for the intralymphatic administration of cellular therapies. Further aspects of the invention provide compositions, kits and uses thereof related to such methods.

Sepsis is defined as a systemic inflammatory response to infection, while severe sepsis (SS) is a sepsis complicated by acute organ dysfunction. Lung infections, in particular community-acquire pneumonia (CAP), are the leading cause of SS. The pathophysiologic mechanism of CAP-mediated SS is the complete dysregulation of the patients immune system. In an initial phase, the systemic hyperactivation of the host immune response against infection leads to high levels of inflammatory mediators, systemic vasodilatation, micro-vascular thrombosis and organ failure. In a second phase, the exaggerated activation of the immune response leads to a state of immunoparalysis, which is characterized by the occurrence of secondary, opportunistic infections. This makes CAP-mediated SS a life-threatening condition with mortality rates as high as 28-50%. The current standard of care (infection removal and control, functional support) does not improve the high mortality and, thus, CAP-mediated SS represents a major unmet medical need with a huge social burden. Therefore, treatments with the potential to modulate both the initial exacerbated immunoactivation and the subsequent immunosuppression are needed. Mesenchymal stem cells (MSCs), including adipose mesenchymal stem cells (ASCs), are known for their broad range of immunomodulatory properties, targeting multiple pro- and anti-inflammatory pathways, and possess antimicrobial capacities (releasing bactericidal peptides and promoting the phagocytosis by immune cells). Indeed, therapeutic benefit of MSC treatment in in vivo experimental models of sepsis has been extensively reported. The SEPCELL consortium believes that cell therapy with allogeneic ASCs may be an innovative therapeutic approach in order to re-establish the normal immune homeostasis of CAP-mediated SS patients, reducing organ injury and restoring organ functionality. A phase Ia/IIb clinical trial will be performed to test this possibility.

TiGenix and University of Seville | Date: 2016-11-23

The invention relates to the use of mesenchymal stem cells (MSCs) for treating systemic inflammatory response syndrome (SIRS) in a subject. The invention provides compositions, uses and methods for the treatment of SIRS.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.1.4-1 | Award Amount: 7.64M | Year: 2012

Treating Rheumatoid Arthritis (RA) is a crucial challenge for the health systems. RA is the most common inflammatory arthritis, affecting 0.5% to 1% of the general population worldwide with little variation of the prevalence among countries. The current pharmacological management of RA involves early intervention with synthetic disease modifying anti-rheumatic drugs (DMARDs) either singly or in combination. Despite all those treatments, RA remains as an unmet clinical need where several concerns about long term treatments based on biologics have been arisen (Bongartz, 2009) while there are still approximately 20-40% of rheumathoid arthritis patients that do not have an adequate response to anti-TNF (Vander CB, 2006). The preclinical data obtained by the REGENER-AR consortium in a RA efficacy model in mice using allogeneic eASCs by intravenous route, demonstrated that mesenchymal expanded adult stem cells (eASC) extracted from adipose tissue have a large potential for treating RA. REGENER-AR consortium has defined a clinical translational project which aim is to develop a broadly available and clinically applicable treatment for RA by exploiting the biology of living human eASCs. To do that, the consortium is developing an Advanced Therapy Medicinal Product (ATMP) based on allogeneic eASCs for the treatment of RA (product internal code, Cx611) and ready for starting the clinical research (IMPD and clinical protocol has been approved by the regulatory agencies in January 2011). To accomplish this goal, it will be necessary to test this product through a phase Ib/IIa clinical trial in order to define the safety and feasibility of the systemic administration of allogeneic eASCS in patients with RA, but it will be necessary as well to advance in the difficulties that prevent cell therapy to be considered as a largely available product in the market facing several issues related to the production scale-up, effectively clinical treatment and regulatory affairs compilance

TiGenix and Autonomous University of Madrid | Date: 2013-09-03

Provided herein are novel methods and compositions utilizing adipose tissue-derived stromal stem cells for treating fistulae.

TiGenix and Consejo Superior De Investigaciones Cientificas | Date: 2014-08-20

The present invention provides a population of connective tissue derived cells that respond to interferon-gamma (IFN-) by expressing indolamine-2,3-dioxygenase (IDO) for use in preventing, treating or ameliorating one or more symptoms associated with disorders in which modulation of a subjects immune system is beneficial, including, but not limited to, autoimmune diseases, inflammatory disorders, and immunologically mediated diseases including rejection of transplanted organs and tissues.

Provided herein are novel methods and composition utilizing adipose tissue-derived stromal stem cells for treating fistulae.

Identification and isolation of multipotent cells from non-osteochondral mesenchymal tissue. This invention relates to the identification and isolation of multipotent cells from non-osteochondral mesenchymal tissue. Specifically, it relates to an adult multipotent cell or a cell population or composition comprising said cell, isolated from non-osteochondral mesenchymal tissue, characterized in that it is positive for the following markers: CD9, CD10, CD13, CD29, CD44, CD49A, CD51, CD54, CD55, CD58, CD59, CD90 and CD105 and because it lacks expression of the following markers: CD11b, CD14, CD15, CD16, CD31, CD34, CD45, CD49f, CD102, CD104, CD106 and CD133.

The present invention provides a method for determining the clinical prognosis of a human subject to the administration of a pharmaceutical composition comprising of stem cells (preferably mesenchymal stem cells), stromal cells, regulatory T-cells, fibroblasts and combinations thereof.

The present invention provides a method for treating rheumatoid arthritis comprising the use of mesenchymal stem cells.

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