Skip to main content
Vai all'homepage della Commissione europea (si apre in una nuova finestra)
italiano it
CORDIS - Risultati della ricerca dell’UE
CORDIS

Clinical Development of Advanced Therapeutic Medicinal Product for Acute Kidney Injury

Descrizione del progetto

La terapia con cellule staminali previene i danni renali dopo l’intervento chirurgico

L’insufficienza renale acuta (IRA) è una riduzione improvvisa della funzionalità renale, frequentemente osservata nei pazienti sottoposti a procedure di bypass cardiopolmonare. Questa patologia aumenta notevolmente il rischio di malattia renale cronica, ma non sono disponibili trattamenti efficaci. Il progetto ALOREN, finanziato dal CEI, mira a colmare questa lacuna nel trattamento dell’IRA sviluppando una nuova terapia (KELI-101) che utilizza cellule staminali placentari. Le indagini precliniche indicano che KELI-101 migliora il recupero strutturale e funzionale del rene, riduce l’infiammazione e previene la progressione verso la malattia cronica. La terapia sta ora avanzando verso sperimentazioni cliniche internazionali, con il potenziale di offrire un nuovo trattamento per l’insufficienza renale acuta e potenzialmente per altre condizioni infiammatorie.

Obiettivo

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.

Campo scientifico (EuroSciVoc)

Parole chiave

Programma(i)

Argomento(i)

Meccanismo di finanziamento

HORIZON-EIC-ACC - HORIZON EIC Accelerator

Vedi tutti i progetti finanziati nell’ambito di questo schema di finanziamento

Invito a presentare proposte

(si apre in una nuova finestra) HORIZON-EIC-2024-ACCELERATOR-02

Vedi tutti i progetti finanziati nell’ambito del bando

Coordinatore

Kelifarma
Contributo netto dell'UE
€ 2 499 999,00
Indirizzo
Sukilėlių pr. 89-2
LT-49233 Kaunas
Lituania
PMI
Sì
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Collegamenti
Costo totale
Nessun dato