Programma: Translational Adult Stem Cell Research
The Translational Adult Stem Cell Research programme focuses on new applications for adult (i.e. non-embryonic) stem cells. This includes research whereby stem cells are directly administered, as in bone marrow transplants, or are used to produce an organ or tissue which is then transplanted into the body. Research in which adult stem cells are not isolated from bone marrow, but are used to effect haematopoietic reconstitution, would also qualify for the programme. The approach taken would have to be innovative, however.
Background
In late 2007 the Ministry of Health, Welfare and Sport asked ZonMw to conduct an exploratory study in the field of adult stem cell research. The report of the study, presented to the State Secretary for Health, Welfare and Sport in April 2008, revealed major potential for adult stem cell research in the Netherlands. A great deal of promising translational research on the use of adult stem cells to treat various conditions is already taking place in this country. Some of that research is at the applied laboratory or clinical research stage. However, major problems arise when it comes to funding the research. Before patients can be exposed to a new application in an experimental setting, it must be demonstrated that the therapy is safe and likely to be effective. Stem cells also have to be produced in sufficient number and in accordance with strict quality standards. In practical terms, these standards generally make the research time-consuming, labour-intensive and very costly. This grants programme is therefore designed to help translate adult stem cell research to clinical practice.
In September 2008, in response to the proposal for a research programme in ZonMw’s report on the exploratory study, the Ministry of Health, Welfare and Sport undertook to provide the necessary funding for the implementation of the ‘Translational Adult Stem Cell Research’ programme for the period 2008-2022.
On Monday 1 December 2008 State Secretary Jet Bussemaker launched the programme, which is known by the acronym TAS.
Programme information
Budget: € 23.500.000
Status: Execution
Duration:
2008
2022
Contact information
Goal
The goal of the programme is to promote clinical research into adult stem cell applications after thorough pre-clinical translational research.
Translational research
translates promising research results into clinical applications. It ensures that the transition to clinical practice occurs in the correct way. In this programme, translational research includes:
Pre-clinical translational research aimed at making adult stem cells available for new approaches in a safe and effective manner, with a view to further development in clinical studies. This might include the characterisation and culturing of stem cells, the development of animal models and the validation of new approaches in animal experiments. The routine production and quality control of batches of stem cells intended for clinical research requires particular attention. This last process may be performed in collaboration with external parties.
Clinical research in phase A Pre-clinical translational research and/or phase B Clinical research studies after evaluation of pre-clinical research has prompted a need for such studies, including the development of clinical protocols.
Projects
There are two phases to each project in the programme, to which specific conditions apply:
Phase A: Pre-clinical translational research
pre-clinical (A1);
research into safety and effectiveness;
max. € 600,000
max. 4 years
pharmaceutical (A2);
GMP production of cells and
safety tests/toxicology/quality control
max. € 750,000
max. 2 years
Phase B: Clinical research
under clinical supervision;
max. € 650,000
max. 2 years
The programme should lead to new clinical applications. Projects involving pre-clinical translational research (A) will therefore qualify for funding only in combination with clinical research (A+B). Applications may also be submitted for grants to fund the clinical phase (B) of a project whose pre-clinical phase (A1) is already complete. The application will then consist of the pharmaceutical part (A2) and the clinical phase (B). In such cases it is important to demonstrate that the pre-clinical part was successful. Indeed, in projects being funded entirely by the programme (i.e. all phases), it must also be shown that one phase has been successfully completed before the next begins. An evaluation will take place after each phase.
Finally, grants are also available for the clinical phase of projects whose pre-clinical and pharmaceutical phases are already complete. Phase A need not have been funded under this programme. In the case of such phase B projects, it is important that the applicant adequately demonstrate that the therapy is safe and is likely to be effective in patients. The approval of the Central Committee on Research Involving Human Subjects (CCMO) will at any rate be needed before the clinical phase of the project can be funded.
