If you are a cell therapy manufacturer struggling with scalable, standardized production — this project developed streamlined manufacturing technology for allogeneic adipose-derived stromal cells, including production processes ready to start across a 10-partner, 7-country network. Their approach to rationalising cell production and distribution could directly inform your scale-up strategy.
Off-the-Shelf Stem Cell Treatment for Heart Failure Patients With No Other Options
Millions of people survive heart attacks but end up with damaged hearts that no surgery or medication can fully fix. The SCIENCE project tested whether injecting fat-derived stem cells from a healthy donor — like a universal blood transfusion but for heart repair — could help these patients recover heart function. They ran a large clinical trial across multiple European hospitals and built the manufacturing process to produce these cells at scale. Think of it as moving from a custom-made, one-patient-at-a-time approach to something more like a ready-made medicine you can ship to any hospital.
What needed solving
Ischemic heart disease kills 4 million Europeans every year and is the leading cause of death across the continent. Conventional treatments have hit their ceiling — a growing number of patients with chronic heart disease or heart failure simply have no further treatment options. This creates a massive unmet medical need in an ageing population, driving up healthcare costs with no current solution.
What was built
The project built a complete clinical trial infrastructure including IWRS, eCRF and clinical databases, and brought allogeneic adipose-derived stem cell manufacturing to production-ready status. A multicentre clinical trial was conducted across multiple European countries to test the therapy in real patients with ischemic heart disease.
Who needs this
Who can put this to work
If you are a cardiology-focused company looking for next-generation treatments for the 4 million Europeans dying from ischemic heart disease annually — this project ran a multicentre clinical trial with allogeneic stem cells, complete with clinical databases (IWRS, eCRF) and regulatory-grade trial infrastructure. The data and methodology could complement or extend your cardiac therapy pipeline.
If you run a hospital network treating chronic heart failure patients who have exhausted all conventional options — this project demonstrated a treatment pathway using off-the-shelf donor stem cells that eliminates the need for patient-specific cell harvesting. With 17 million IHD deaths worldwide each year, even incremental improvements in treatment options translate to significant patient volume and revenue.
Quick answers
What would it cost to license or adopt this stem cell therapy?
The project received EUR 5,998,882 in EU funding to develop the therapy and run a multicentre clinical trial. Licensing terms would need to be negotiated with the coordinator (Region Hovedstaden, Denmark) and consortium partners. Allogeneic (donor-based) cells are generally cheaper to produce than patient-specific therapies, which was a core design goal.
Can this be manufactured at industrial scale?
Yes, scalable manufacturing was a primary objective. The consortium specifically aimed to simplify and rationalise cell production and distribution using state-of-the-art manufacturing technology. The deliverable 'Production ready to start' confirms the manufacturing process reached operational readiness.
What is the IP situation and how can a company license this?
The project involved 10 partners across 7 countries, with 4 industry partners and 5 universities. IP is likely shared across the consortium under their grant agreement. Companies interested in licensing should contact the coordinating institution, Region Hovedstaden in Denmark, to discuss terms and freedom-to-operate.
Has this been tested in real patients?
Yes. The project conducted a multicentre clinical trial across European hospitals. Clinical infrastructure including IWRS (Interactive Web Response System), eCRF (electronic Case Report Forms), and a clinical database were developed and deployed. Based on available project data, specific trial outcome results would need to be obtained from the consortium.
What regulatory pathway does this follow?
The consortium explicitly aimed to pave the way for future approval by national authorities throughout Europe as a standard form of care. The project worked in close collaboration with relevant regulatory authorities. The allogeneic cell therapy approach was designed to meet Advanced Therapy Medicinal Product (ATMP) requirements.
How does this compare to existing heart failure treatments?
Conventional therapies have reduced mortality significantly but leave an increasing number of chronic IHD and heart failure patients without further treatment options. This stem cell therapy targets specifically those patients who have exhausted all other treatments — a growing population in ageing European societies.
Who built it
The SCIENCE consortium brings together 10 partners from 7 European countries (Austria, Belgium, Germany, Denmark, Netherlands, Poland, Slovenia), with a strong 40% industry ratio — 4 industry partners alongside 5 universities and 1 other organization. Coordinated by Region Hovedstaden in Denmark (a major public hospital system), the project was backed by nearly EUR 6 million in EU funding. The mix of academic medical centres and industry partners signals a deliberate push toward commercialisation, not just lab research. The broad geographic spread across 7 countries also means the clinical trial data covers diverse patient populations, which strengthens the regulatory case for pan-European approval.
- REGION HOVEDSTADENCoordinator · DK
- MEDIZINISCHE UNIVERSITAET WIENparticipant · AT
- KOBENHAVNS UNIVERSITETparticipant · DK
- GORNOSLASKIE CENTRUM MEDYCZNE IM. PROF. LESZKA GIECA SLASKIEGO UNIWERSYTETU MEDYCZNEGO W KATOWICACHthirdparty · PL
- UNIVERSITAIR MEDISCH CENTRUM UTRECHTparticipant · NL
- SLASKI UNIWERSYTET MEDYCZNY W KATOWICACHparticipant · PL
- TERUMO BCT EUROPE NVparticipant · BE
- UNIVERZITETNI KLINICNI CENTER LJUBLJANAparticipant · SI
Region Hovedstaden (Copenhagen, Denmark) — reach out to their translational medicine or cell therapy department
Talk to the team behind this work.
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