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Cultivated Adult Stem Cells as Alternative for Damaged tissue

Periodic Report Summary - CASCADE (Cultivated Adult Stem Cells as Alternative for Damaged tissue)

Cascade ('Cultivated adult stem cells as alternative for damaged tissue'), a consortium granted by the Seventh Framework Programme of the European Commission (HEALTH-F5-2009-223236), links together non-profit public bodies, higher education establishments, research organisations and SMEs from five Europeans countries. Cascade provides the European Community with a unique expertise focused on the GMP production of mesenchymal stem cells (MSC) and their safe use in treating skin and corneal wounds.

Tissue repair is becoming a major issue for millions of patients each year and will continue to grow in the future. Achieving quality standards in tissue repair will be a key milestone in delivering health solutions to the ageing European population. In spite of the promises they hold, tissue and cell therapies are highly demanding in terms of production conditions and this influences the final cost of such therapeutic solutions. Moreover, regenerative medicine is still at an early research stage and therefore scientific and regulatory questions must be solved in relation to the implementation of clinical trials of these products and their market approval by regulatory bodies. Finally, stem cell research and clinical use, particularly the application of manipulated cells from allogeneic origin, raise important ethical issues that should be addressed to generate adequate solutions.

The main objective of Cascade is to develop standardised GMP methods of collecting and processing adult stem cells for clinical applications to repair damaged human tissue. In order to achieve this ambitious objective, Cascade is divided in three main sub-objectives:

The first objective is the development of culture conditions and standard tools for the generation of allogeneic and autologous GMP-grade MSC derived from bone marrow (BM), adipose tissue (AT), umbilical cord blood (CB) and amniotic membrane (AM).

The second objective of Cascade is the evaluation of the therapeutic potential and the mechanism of action of MSC for chronic wound healing of skin and cornea by in vitro and in vivo models.

The third objective is the definition of the general ethical perspectives of cellular therapies, including such issues as donations of BM cells for the generation of "pluri-use allogeneic" MSC products, particularly in relation to safety and quality aspects for donors and patients.

Finally, as the result of the three first objectives, the final objective is the preparation of study protocols for multicentre, prospective, double-blind and placebo-controlled trials to evaluate the safety and efficacy of MSC applications for the treatment of skin ulcers and corneal chronic ulceration.

During the first 18 months of the project, Cascade has developed and provided processes for MSC culture from bone marrow and adipose tissue, and is developing methods for MSC culture from cord blood and amniotic membrane. These processes are GMP-compliant, the efficiency and safety controls are close to be defined, and adaptation for simple and reproductive productions in fully closed and automated system is in progress.

The in vitro and in vivo models for immunological testing, migration and efficiency in wound healing are established. They will allow Cascade to define the conditions of clinical trials for skin and cornea repair using MSCs.

In parallel, Cascade has built-up a legislative database that ensures that the produced MSCs are compliant with the required ethical needs and the different European regulations, and the discussion of preclinical data and new relevant controls for safety and release of MSC products are in progress with EMEA and CAT.

Moreover, the processes developed within Cascade will be the basis of MSC productions for clinical trials in another program of the Seventh Framework Program dedicated to bone repair (Reborne: 'Regenerating bone defects using new biomedical engineering approaches', FP7-HEALTH-2009 GA No. 241879).