A multi-centre, single-arm study to demonstrate the efficacy of bone marrow allogeneic mesenchymal cells combined with biomaterial (combined ATMP) for bone healing in delayed union and non-union after long bone fractures (OrthoAlloUnion).

Delayed consolidation or non-union long bone fracture

Percentage of patients with radiological consolidation (Yes/No) at 12 months after the intervention.

Percentage of patients with radiological bone consolidation (Yes/No) at 6 months after the intervention., Value of Reborne scale at 6 and 12 months, Pain score at preoperative, 6 and 12 months after surgery, using Numeric Rating Score (NRS) (from 0 to 10) with and without weight bearing., Percentage of patients with reoperation at the callus site (Yes/No) at 6 and 12 months after surgical intervention. Estimated as the number of reoperations in the callus site, over the total number of treated patients., Percentage of patients with bone consolidation (Yes/No) at 6 and 12 months after the intervention. Estimated as the number of bone consolidations, over the total number of treated patients., Volumetric assessment of the regenerated bone, as a percentage of 10cm3 of the affected long bone, applying the Region of Interest methodology using Osirix® software in full CT images, at preoperative, 6 and 12 months after surgery, Safety endpoints include: - Early complication rate: percentage of patients with complications within the first 3 months after surgery. - Overall complication rate as percentage of patients with local or general complications regarding potential effects of the treatment at any time after surgery.

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