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COMPLETED
NCT01842477
PHASE2

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

View on ClinicalTrials.gov

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

BIOLOGICAL

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