drugset / Trial / NCT01206179

Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell

NCT01206179 ↗

Phase 1 Completed 6 enrolled Royan Institute
NaSingle-groupOpen-labelTreatment

Summary

Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields). Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce later surgeries required to augment the healing process and to accelerate the time to healing.

Timeline

Start
2009-03
Primary completion
2011-03
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject mesenchymal cells Cell therapy 2e+07 cells Other

Indications

No indication recorded.