Research & Innovation - Participant Portal

TOPIC : Clinical research on regenerative medicine

Topic identifier: SC1-PM-11-2016-2017
Publication date: 14 October 2015

Types of action: RIA Research and Innovation action
DeadlineModel:
Opening date:
single-stage
20 October 2015
Deadline: 13 April 2016 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2016-2017
Topic Description
Specific Challenge:

Translating basic knowledge on regenerative medicine into the clinic is often delayed by the difficulty of undertaking "first in man" studies and carrying out the specific research needed for proving safety and efficacy of new treatments as well as reproducibility of their therapeutic effect. Moreover, financing for these steps in the new therapeutic field of regenerative medicine is particularly scarce, due to lack of established business and regulatory models. The challenge is to overcome these hurdles to in-patient research and to determine the potential of new regenerative therapies.

Scope:

Proposals should target regenerative medicine therapies which are ready for clinical (in-patient) research and should focus on one specific clinical phase of work. Any stage of clinical work (e.g., first in man, late stage trial, observational study) may be proposed though later stages are preferred; clinical work should represent the core of the proposal. To justify the clinical work proposed, phase I proposals must present appropriate preclinical and toxicology data, and later phase proposals must present appropriate preliminary results.

Proposals should include authorization to conduct clinical trials and ethical approvals or provide evidence of regulatory engagement and that such approval is close. Preference will be given to proposals which are closest to having approvals in place for clinical work to start. Since the objective is to test new regenerative therapies, proposals may address any disease or condition but a justification for the choice must be provided. Proposers should also justify why the therapy proposed is regenerative and how it represents a new approach compared to any existing treatment. Sex and gender differences should be investigated, where relevant. To allow an adequate coverage in the field of regenerative medicine, proposals should take into account the projects previously funded under this topic in Horizon 2020[1].

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected Impact:
  • Obtain results by means of in-patient regenerative medicine research that allows new therapies to safely reach the next level of testing or medical practice.
  • Stimulate growth and competitiveness of European regenerative medicine including European small and medium-sized enterprises and industry operating in the sector.
  • Increase the attractiveness of Europe as a location of choice for development of new therapeutic options.
  • Lever existing investments in fundamental research into regenerative medicine.
  • Develop new approaches to currently untreatable diseases.

[1]Project abstracts will be provided on the call page on the Participant Portal.

Topic conditions and documents

Please read carefully all provisions below before the preparation of your application.
 

  1. List of countries and applicable rules for funding: described in part A of the General Annexes of the General Note also that a number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in some Horizon 2020 topics (to check funding conditions, follow the links to Australia, Brazil, Canada, China, Hong Kong & Macau, Japan, Republic of Korea, Mexico, Russia, Taiwan, USA*).
    *Note that US participants in projects under the Horizon 2020 "Health, Demographic Change and Wellbeing" Societal Challenge are automatically eligible for EU-funding according to the provisions in the relevant work programme
     
  2. Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme.

    Proposal page limits and layout: Please refer to Part B of the standard proposal template.

     
  3. Evaluation

    3.1  Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme, with the following exceptions: The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.

    3.2 Submission and evaluation process: Guide to the submission and evaluation process

          
  4. Indicative timetable for evaluation and grant agreement:

    Information on the outcome of single-stage evaluation: maximum 5 months from the deadline for submission.
    Signature of grant agreements: maximum 8 months from the deadline for submission.

     
  5. Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:

    Research and Innovation Action:

    Specific provisions and funding rates
    Standard proposal template
    Specific evaluation form
    H2020 General MGA -Multi-Beneficiary
    Annotated Grant Agreement

     
  6. Additional provisions:

    Horizon 2020 budget flexibility

    Classified information

     
  7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.

     
  8. Additional documents:

    H2020 Work Programme 2016-17: Health, demographic change and wellbeing

    H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation

    H2020 Work Programme 2016-17: General Annexes

    Legal basis: Horizon 2020 - Regulation of Establishment

    Legal basis: Horizon 2020 Rules for Participation

    Legal basis: Horizon 2020 Specific Programme

 

Additional documents

Download all documents
(EN only, incl. the additional docs.)

  • Essential information for clinical studies en
  • FAQ en
  • Horizon 2020 collaborative projects supported by the Regenerative Medicine clinical trials calls en

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