Our Centre of Excellence (SFF) proposal

Turning scientific discovery into clinical application

The proposed Norwegian Centre of Excellence in Tissue Engineering and Regenerative Medicine (TEReg) will combine several disciplines, and develop new concepts and ideas to further accelerate scientific breakthroughs. We have a unique experience in combining stem cell research with clinical trials, and this has established us as a leading research group in our field.

As of 2020, five stem cell-based therapies are undergoing clinical trials in Bergen including a randomized controlled multicenter phase III trial (Maxibone). This achievement is unique in Europe and we have been able to translate a laboratory idea into clinical practice. The main objective of TEReg is to develop a platform technology for regenerative medicine, which on one hand fulfils basic requirements, and on the other hand can be personalized to the specific patient’s situation.

The overall concept of TEReg is the combination of cell therapy, using mesenchymal stem cells (MSCs) with novel biomaterials, innovative 3-D structural design, biomanufacturing and therapy. Currently, there are significant engineering challenges in upscaling laboratory process designs into clinically effective, safe and economically viable competitive products.

The center will be positioned to translate scientific discoveries to clinical applications – and to industry. TEReg is the result of substantial research efforts invested into a collaboration between UiB and Haukeland University Hospital (HUS). We want to change the standard of care for incurable diseases, allowing regenerative medicine to become a cost effective therapy, preferable to current approaches.

Because we have help from industry partners, our vision is to introduce stem cell-based treatment as a routine therapy at hospitals within 5-10 years.

Of special interest: TEReg plans future clinical trials using allogeneic cells. Preclinical studies are essential to identify biomarkers for selecting the most suitable donors, to develop pre-clinical data to ensure safety and efficacy on allogenic cells in order to prepare a first in man study. Research partners will contribute to the fields of molecular and cell biology, material sciences, nano-technology, scaffold synthesis and bioreactor-technology, while a combination of SMEs and larger industry partners will bring in knowledge in upscaling from “lab to market”.

The Center for Stem Cell Therapy and Regenerative Medicine, CCReg, will serve as a vessel to combine several disciplines to develop therapeutic concepts for tissue regeneration. Our unique experience in combining stem cell and clinical trials in our research has established us as a leading research group in the field.

Research Goals

It is our goal that the data generated from the research activities at the center will directly and positively impact on the daily life of our patients, leading to treatment of number of incurable diseases and to develop new strategies for therapeutic intervention.

The constant demand for improved, reliable and low cost products, as well as the increasing number of malfunction tissues or organs due to the increasing ageing and life expectancy of the population in Norway and Europe, creates the obvious need for developing regenerative therapeutic strategies. The main objective is the successful validation of a novel, clearly defined clinical applications for stem cell therapy that answer the demands of the identified questions based on the research and pre-clinical outcomes of our previous and ongoing projects. The data generated as an outcome of the joint effort placed by the partners will have a positive impact on and help develop Norwegian and European capability in regenerating defected tissues according to the concept of regenerative medicine.

A center for excellence in regenerative medicine, will pave the way for clinical studies by conducting proof-of principle clinical studies using biomaterial/cell therapy. Furthermore, several parts of the planned activities can impact industry and detailed commercialization strategies will be developed.

In the line with SC1 policy driver “moving towards the effective integration of personalised medicine approaches into healthcare services and systems to the benefit of patients and citizens” TEReg aims to make a substantial step by creating a fully personalised regenerative platform for the treatment of incurable diseases. Despite all efforts, only a limited number of personalised medicine approaches have so far managed the long road from basic research to clinical application. The Council of the European Union on the Personalised medicine for patients subject states “personalised medicine relates to the broader concept of patient-centred care, which takes into account that, in general, healthcare systems need to better respond to patient needs”. TEReg will be a platform where patients will be offered a fully personalised regenerative therapy. By strengthening the uptake of innovation in society, TEReg will significantly contribute to the United Nations Sustainable Development Goal 3 “Ensure healthy lives and promote well-being for all at all ages”. Society will benefit for many years from the technologies that will be developed for the care of patients. The investment required will lead to a financial benefit which includes various areas of economic development in the EU market. The outcome of TEReg will also influence the industry, hence, successful realisation of the proposed center will have a crucial impact. A wide acceptance and better cost-to-benefit ratio for the treatment will secure reimbursements from insurance companies/health care systems and make regenerative therapies affordable for all patients even in economically unfavourable situations.

The potential benefits for the patients can be summarised:

  • improved quality of life
  • shorter time of convalescence due to accelerated tissue formation
  • faster re-entry into work
  • less partial disablements due to donor site morbidities
  • less risk of persistent pain and impaired function
  • less risk of occupational disability

The benefits for the health care system and for society as a whole can be summarised:

  • less costs for health system by saving health system resources
  • reducing the hospitalization costs and rehabilitation time
  • less risk for invalids (e.g. occupational redeployments, health and retirement costs)

The people behind the project

A Norwegian Centre of Excellence in Tissue Engineering and Regenerative Medicine is planned to be established as a joint effort between University of Bergen (UiB) and Haukeland University Hospital (HUH). To further expand the center we have asked international experts in their field to assist in the growth of TEReg. Combined with their expertise and knowledge TEReg will provide groundbreaking research and inspire future generation of scientist.

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