Clinical Trial: A Clinical Trial to Assess the Effect of HC-SVT-1001 in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II Clinical Trial to Assess the Effect of HC-SVT-1001 (Autologous Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) in the Surgical Treatment of A
Brief Summary: The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 in the surgical treatment of atrophic nonunion in long bones.
Detailed Summary:
Sponsor: Salvat
Current Primary Outcome:
- Safety of HC-SVT-1001 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events. [ Time Frame: Up to 24 months after surgery. ]
- Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation. [ Time Frame: Within 6 months after surgery. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Comparative statistical analysis [ Time Frame: Up to 24 months after surgery. ]
Original Secondary Outcome: Same as current
Information By: Salvat
Dates:
Date Received: April 15, 2015
Date Started: November 2015
Date Completion: December 2018
Last Updated: April 22, 2016
Last Verified: April 2016