PREMSTEM: The brain injury in the premature born infant: stem cell regeneration network

Overview

PREMSTEM is a €9M research project funded by the European Union’s prestigious Horizon 2020 research and innovation programme. It is comprised of a group of researchers and advocacy organisations from across the globe. The project will develop a new regenerative stem cell therapy to repair the brain damage caused by premature birth, also known as encephalopathy of prematurity (EOP). The project started in January 2020 and will run for 5 years.

What are the consequences of brain injury on a preterm born baby?

In advanced healthcare settings, more than half of babies born before 28 weeks survive. However, around a third of those born between 28 and 32 weeks will suffer lifelong disability, including cerebral palsy, severely impaired cognitive functions, and psychiatric disorders such as attention deficit and hyperactivity disorder (ADHD) and autism spectrum disorder (ASD).
Even babies born ‘late preterm’ (between 32 and 37 weeks) are at increased risk of neonatal mortality and morbidity, including increased rates of cerebral palsy and lower IQ.
Although extreme prematurity leads to the most severe problems, even being born a few weeks early can have significant adverse effects, such as an increased need for special educational support at school.

What treatments are there for brain injuries in preterm babies?

There are currently no treatments available to repair this brain damage. Therefore, the most important strategy is one that promotes regeneration of the damaged brain. Diagnosis of the brain damage is not available until days or weeks after birth.

How will the PREMSTEM project make a difference for preterm babies? 

The PREMSTEM project brings together world leading clinicians, researchers, stakeholder advocacy groups and an industrial partner with well-established experience in neonatology and drug development.
The research aims to create a new therapy to treat brain damage associated with preterm birth.
In this project, the use of stem cells is being researched as a regenerative therapy to improve the quality of life for preterm infants who are at a greater risk of brain injury. In doing so, this will also reduce the emotional and financial strains of their carers.

 

 

What is the impact of PREMSTEM on these babies, their carers and our society?

The damaging effects of preterm birth can have a negative impact on families and communities. Besides the physical and emotional costs to individuals and their carers, the lifetime costs for provision of care for one child affected by cerebral palsy is approximately 1.3 million US dollars (or 1.1 million euros).
The PREMSTEM project will test the abilities of stem cell administration as a regenerative therapy for brain damage associated with premature birth. Additionally, new, inexpensive, and easy to use imaging tools which allow clinicians the ability to readily identify brain damage in preterm infants will be developed.
Despite the prevalence of preterm birth, this large patient group is traditionally understudied. Through the PREMSTEM project the research agenda for neonatal innovation will be promoted in order to provide a brighter future for preterm infants and their families.

 

EXPECTED OUTCOMES

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A regenerative therapy to treat brain damage                                                                                                                                                                                                                                                                                                                                                                                                                                                                      

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A stronger research agenda to address the needs of preterm infants

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New technology to identify brain damage                                                                                                                                                                                                                                                                                                                                                                                                                                                                               

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Positive outcomes for patients and carers

 

The role of EFCNI in PREMSTEM

EFCNI is leader of Work Package (WP) 6 in the PREMSTEM project entitled “Increase the visibility and impact of PREMSTEM on health and society by developing a communication/dissemination and exploitation strategy.” The objectives of this Work Package are the following:
– To increase the visibility and impact on health and society of PREMSTEM by reaching out to key stakeholders in the neonatal health system (scientific community, clinicians, health care professionals, patient/consumer organisations, policy makers, the general public)
– Identifying the most effective ways to generate regulatory approval to ensure that the stem cell therapy moves into clinical trial to improve human health
– The specific involvement of patient/consumer representatives in order to give input and feedback to all information on the project that will be provided to key stakeholders, including patients/consumers and parents
– To ensure the most appropriate use of project findings through the development of an exploitation strategy and roadmap that will last beyond the project lifetime

EFCNI will work closely with 5 out of 15 PREMSTEM project partners to achieve these objectives through specific tasks. The partners we are working closely with are as follows:
INSERM – Institut national de la santé et de la recherche nationale, France
INSERM Transfert SA, France
RMIT-EU – Royal Melbourne Institute of Technology SL, Spain
CPA – Cerebral Palsy Alliance, Australia
CHIESI Farmaceutici SPA, Italy

LINKS AND DOWNLOADS
For more information on the project, visit the website:
https://www.premstem.eu/

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Downloads
As the project progresses, this section will be updated with relevant documents.

PLEASE NOTE
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 874721