CASCADE

Cultivated Adult Stem Cells as Alternative for Damaged tissue

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 Obiettivo del progetto (Objective)

'Rapid progress in stem cell research pave the way for the development and use of new cell therapy products in regenerative medicine. The objective of CASCADE is to provide the European Community with unique expertise which focuses on the GMP production of mesenchymal stem cells (MSC) and their use in treating skin and corneal wounds, so that quality and safety criteria are paramount and match therapeutic expectations. Commencing with known procedures, CASCADE will develop innovative technologies based on the expertise of its partners. Among our research themes, the specific issue of multiple recipients and universal donors will be investigated. To this end, human MSC will be derived from 4 tissues, bone marrow, fat tissue, cord blood and amniotic membrane, according to good manufacturing practice (GMP). Phenotypic identity of GMP produced MSC, their genetic status and their potential for transformation will constitute the basis for establishing standards for controlling cell production. The efficacy of GMP produced MSC will be tested in in vitro and in vivo models, and the immunological consequences of their use will be studied. Moreover, during the whole CASCADE initiative, ethical and legal issues raised as a result of MSC therapies will be considered. Direct collaboration with two clinical networks will allow CASCADE to finely tune production specifications, and define optimal clinical protocols for these MSC-based cellular therapies. CASCADE will therefore gather together leading European cell therapy laboratories with unrivalled expertise in the production of therapeutic cells and in MSC biology, four SMEs with specific know-how in GMP production of cells and two clinical networks in dermatology and ophthalmology. The outcome will be a consortium that encompasses all the technologies and skills required to efficiently develop innovative technologies for the production of clinical grade MSC and to translate this production into a cell drug to repair wounds.'

Introduzione (Teaser)

Stem cell research holds promise for advances in regenerative medicine. Tissue repair is one such area that stands to benefit as related research forges ahead.

Descrizione progetto (Article)

Setting quality standards in tissue repair is a primary concern for improved health solutions to Europe's ageing population in particular. The production processes of tissue and cell therapies are highly demanding and this ups their final cost.

The 'Cultivated adult stem cells as alternative for damaged tissue' (Cascade) project offers expertise focusing on the good manufacturing practice (GMP) of producing mesenchymal stem cells (MSCs). With a high capacity for self renewal and ability to differentiate into a variety of cell types, MSCs have great therapeutic potential for tissue repair. Their use in treating skin and corneal wounds demands that standards of quality and safety are of the highest order and live up to therapeutic expectations.

Cascade is working to develop innovative technologies based on the expertise of its partners. The consortium brings together non-profit organisations, higher education institutions, research centres and small and medium-sized enterprises from five European countries. The project's main objective is to develop standardised and GMP-compliant methods of collecting and cultivating MSC intended for clinical use in the repair of damaged human tissue.

in line with its primary objectives, in the first 18 months of the project Cascade developed and provided GMP-compliant processes for MSC culture from bone marrow and adipose tissue. It is now developing methods for MSC culture from cord blood and amniotic membrane. Researchers have established in vitro and in vivo models for immunological testing, migration and efficiency in wound healing. These will help define the conditions necessary for clinical trials investigating the use of MSCs for skin and cornea repair. Project partners have set up a legislative database that ensures the produced MSCs adhere to ethical needs and varying European regulations.

the ultimate goal is to prepare study protocols for various trials that can evaluate the safety and efficacy of MSC applications for the treatment of chronic skin wounds. Presently, talks are being held with the European Medicines Agency and the Committee for Advanced Therapies on preclinical data and new relevant controls for safety and release of MSC products.