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. ]

Comparative statistical analysis between the 10 patients of this study and the data of 14 consecutive cases of refractory nonunion of long bones that have been treated since Sept-2009 with 40x10(6) autologous fat stem adult mesenchymal and under AEMPS compassionate use requirements.


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