Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
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.
Official title: Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing in Patients With Delayed Consolidation After Long Bone Fracture Requiring Graft Apposition or Alternative Orthobiologics
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2013-05
Completion Date
2016-02-05
Last Updated
2026-06-04
Healthy Volunteers
No
Interventions
Implantation of bone substitute plus autologous cultured mesenchymal cells
Implantation surgery of a synthetic bone substitute associated with autologous bone marrow cells expanded
Locations (5)
Depatment of Orthopaedic Surgery, Hôpital Henri Mondor
Créteil, France
Department of Orthopaedic Surgery, CHRU Tours
Tours, France
Department of Orthopaedic Trauma, University of Ulm
Ulm, Germany
Istituto Ortopedico Rizzoli, Bologna
Bologna, Italy
Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz
Madrid, Spain