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Clinical Development of Advanced Therapeutic Medicinal Product for Acute Kidney Injury

Project description

Stem cell therapy prevents kidney damage after surgery

Acute kidney injury (AKI) represents a sudden reduction in kidney function, frequently observed in patients undergoing cardiopulmonary bypass procedures. This condition significantly increases the risk of chronic kidney disease but there are no effective treatments available. The EIC-funded ALOREN project aims to address this gap in AKI treatment by developing a novel therapy (KELI-101) which utilises placental stem cells. Preclinical investigations indicate that KELI-101 improves the structural and functional recovery of the kidney, reduces inflammation, and prevents progression to chronic disease. The therapy is now advancing to international clinical trials, with the potential to offer new treatment for AKI and possibly other inflammatory conditions.

Objective

Acute Kidney Injury (AKI) is a global health issue, costing over €300 billion annually, and has a seven-fold higher risk of developing chronic kidney disease (CKD), which is projected to be a leading cause of death by 2040. AKI affects up to 40% of patients undergoing cardiopulmonary bypass (CPB) surgery, with currently no effective treatment.

We developed an innovative, immunomodulatory, scalable, placental stem cell-based Advanced Therapeutic Medicinal Product manufacturing platform to address the pressing need for effective treatment of CPB-AKI and prevention of CKD.
Our clinical-grade bioprocessing platform and a lead compound, KELI-101, validated by positive preclinical data, demonstrated a breakthrough potential to significantly enhance survival, improve both functional and structural kidney recovery, reduce inflammation and prevent CKD.

In addition, the multifactorial mode of action of KELI-101 enables its use to treat various inflammatory conditions.

Implemented GMP-grade processes ensure consistent product quality and scalability, reinforcing KELI-101’s potential as a transformative therapy to address critical unmet medical needs globally.

Our seasoned global expert team, combined with strong partnerships with global CROs and leading European clinical sites, enables us to efficiently drive an international Phase 1b/2 multicenter adaptive efficacy and safety trial for KELI-101.

These efforts are aligned with the European Medicines Agency regulatory requirements, positioning us to successfully obtain marketing approval and bring this innovative therapy to the market.

A strong business model approach with European medical centers and health systems, improved patient outcomes, decreased healthcare costs, reduced CKD prevalence, and multifunctional applicability of the platform will play a crucial role in strengthening Europe's autonomy.

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-EIC-ACC - HORIZON EIC Accelerator

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-EIC-2024-ACCELERATOR-02

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Coordinator

Kelifarma
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 2 499 999,00
Address
Sukilėlių pr. 89-2
LT-49233 Kaunas
Lithuania

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

No data
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