Preclinical Assessment in Juvenile Sheep of an Allogeneic Bone Tissue Engineering Product with Wharton's Jelly Mesenchymal Stromal Cells.

ABSTRACT: Secondary osteonecrosis (ON) is a common complication in paediatric cancer survivors. Combining multipotent mesenchymal stromal cells (MSCs) with core decompression surgery halts disease progression and stimulates bone regeneration. However, the success of advanced therapy medicinal products (ATMPs) requires versatile "off-the-shelf" tissue engineering products (TEPs). This study evaluated the safety and efficacy of TEPs loaded with allogeneic MSCs from Wharton's jelly (WJ-MSCs) in a large-animal model of bone regeneration to support a paediatric investigational plan for ON patients. WJ-MSC-laden fibrin-based hydrogels combined with a synthetic bone substitute (PRO-DENSE^TM) were tested in 16 juvenile sheep (8 males and 8 females) distributed in four experimental groups. Each ani

SUBMITTER: Cabrera-Perez R 

PROVIDER: S-EPMC12191425 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature