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ENgineered CArtilage from Nose for the Treatment of Osteoarthritis (ENCANTO)

Project description

Stepping up knee osteoarthritis treatment

Knee osteoarthritis (OA) afflicts over 500 million individuals globally, causing substantial pain and disability. With limited therapeutic options, including only pain management or invasive surgery, the socio-economic burden is staggering. With increasing life expectancy and obesity rates, this burden is set to escalate. With this in mind, the EU-funded ENCANTO project is using tissue-engineered cartilage (N-TEC) to target patellofemoral OA, a challenging subset. N-TEC, crafted from autologous nasal chondrocytes, offers promise for joint reconstruction. The project will evaluate N-TEC’s treatment efficacy. Notably, ENCANTO integrates diverse expertise, spanning tissue engineering, knee surgery, regulatory affairs, and patient advocacy. If successful, N-TEC could revolutionise OA therapy, extending to other joints.

Objective

Knee osteoarthritis (OA) is one of the most common causes of pain and disability, affecting over 500 million people worldwide. The tremendous socio-economic burden caused by OA is expected to further increase due to rising life expectancy and obesity. Current therapeutic approaches are limited to pain management or knee arthroplasty, but no disease-modifying or regenerative treatment is available.

ENCANTO will address this major unmet clinical need by clinically introducing a combined ATMP for the biological reconstruction of the degenerated joint facet in patellofemoral OA (PFOA). This tissue-engineered cartilage (N-TEC), based on autologous nasal chondrocytes and a collagen membrane, was previously successfully used for focal cartilage lesions.
The central part of ENCANTO is an international, blinded, multicenter, prospective randomized controlled phase II trial to clinically assess the efficacy of N-TEC for the treatment of PFOA. Patients’ samples will be analyzed to retrospectively identify PFOA molecular endotypes and associated biomarker signatures with the most successful clinical outcome after N-TEC implantation, to predictively select responders to therapy. To achieve these aims ENCANTO brings together tissue engineers with practice in ATMPs, knee surgery and rehabilitation specialists, research institutes experienced in regulatory affairs, health economics and ATMP development, excellent scientists involved in the assessment of OA endotypes, and patients’ representatives. SMEs from the consortium will develop a road map towards commercial exploitation, including centralized marketing authorization. After demonstrating efficacy for PFOA, N-TEC will be considered for other forms of OA in different joints. ENCANTO will thus introduce the first disease-modifying therapy for cartilage degeneration, enable mobility and social gain for a large patient group and play a pivotal role in strengthening Europe's position in delivering regenerative medicine solutions.

Coordinator

FONDAZIONE POLICLINICO UNIVERSITARIO CAMPUS BIO MEDICO
Net EU contribution
€ 1 346 800,00
Address
VIA ALVARO DEL PORTILLO 200
00128 Roma
Italy

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Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Links
Total cost
€ 1 346 800,00

Participants (15)

Partners (3)