NCT02177565

Autologous Stem Cell Therapy for Fracture Non-union Healing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust · Other Government
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

Detailed description

Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.

Conditions

• Non-union of Fractures

Interventions

Type	Name	Description
BIOLOGICAL	carrier plus in vitro expanded autologous BMSCs	The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container

Timeline

• Start date: 2000-01-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2014-06-27
• Last updated: 2020-03-11

Locations

1 site across 1 country: United Kingdom