Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial.

Affiliation

Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario La Paz-IdiPAZ and Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: [Email]

Abstract

ORTHO-1 is a European, multicentric, first in human clinical trial to prove safety and feasibility after surgical implantation of commercially available biphasic calcium phosphate bioceramic granules associated during surgery with autologous mesenchymal stromal cells expanded from bone marrow (BM-hMSC) under good manufacturing practices, in patients with long bone pseudarthrosis.

Keywords

ATMP,Bioceramic,Bone tissue engineering,Clinical trial,Expanded autologous BM-hMSC,Non-union,