NCT02065167

Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip

Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Universidad Autonoma de Madrid · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.

Detailed description

To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.

Conditions

• Avascular Necrosis of the Femoral Head

Interventions

Type	Name	Description
BIOLOGICAL	Cultured autologous Mesenchymal Cells	Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-06-01
• Completion: 2017-12-01
• First posted: 2014-02-17
• Last updated: 2021-10-14

Locations

6 sites across 4 countries: France, Germany, Italy, Spain