Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing

Summary

Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal tissue. In Europe, about one million patients encounter a surgical bone reconstruction annually and the numbers are increasing due to our ageing population. Bone grafting intends to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of damage, but this is only attained presently by including cells capable of forming bone into the augmentation. Bone autograft is the safest and most effective grafting procedure, since it contains patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance osteoinduction), and it providing a scaffold for the new bone to grow into (osteoconduction). However, bone autograft is limited in quantity (about 20 cc) and its harvesting (e.g. from the iliac crest) represents an additional surgical intervention, with frequent consequent pain and complications. We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically implanted with synthetic bone substitutes contribute to the resolution of the health and socioeconomic complications of delayed union or non-union after diaphyseal and metaphyseal-diaphyseal fractures with safety and efficacy.

Timeline

Start

2013-05

Primary completion

2016-02-05

Completion

2016-02-05

Publications

• Results Gomez-Barrena E, Rosset P, Gebhard F, Hernigou P, Baldini N, Rouard H, Sensebe L, Gonzalo-Daganzo RM, Giordano R, Padilla-Eguiluz N, Garcia-Rey E, Cordero-Ampuero J, Rubio-Suarez JC, Stanovici J, Ehrnthaller C, Huber-Lang M, Flouzat-Lachaniette CH, Chevallier N, Donati DM, Ciapetti G, Fleury S, Fernandez MN, Cabrera JR, Avendano-Sola C, Montemurro T, Panaitescu C, Veronesi E, Rojewski MT, Lotfi R, Dominici M, Schrezenmeier H, Layrolle P. 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. Biomaterials. 2019 Mar;196:100-108. doi: 10.1016/j.biomaterials.2018.03.033. Epub 2018 Mar 19.
• Results Granchi D, Gomez-Barrena E, Rojewski M, Rosset P, Layrolle P, Spazzoli B, Donati DM, Ciapetti G. Changes of Bone Turnover Markers in Long Bone Nonunions Treated with a Regenerative Approach. Stem Cells Int. 2017;2017:3674045. doi: 10.1155/2017/3674045. Epub 2017 Jun 20.

Drugs

Indications

No indication recorded.