Phase II clinical trial to assess the effect of HC-SVT-1001 *(autologous adult trunk mesenchymal cells of adipose tissue expanded and included in βtricalcium-phosphate biomaterial) and HC-SVT-1002†(: allogenic adult trunk mesenchymal cells of adipose tissue expanded and included in βtricalcium-phosphate biomaterial.) in the surgical treatment of atrophic pseudarthrosis in long bones (Bonecure)
Clinical Trials. gov Identifier: NCT02483364
Num Eudra CT: 2013-000930-37
Objectives
Clinical trial to assess the safety and efficacy of implantation of biomaterial containing cultured mesenchymal stem cells of adipose tissue for bone regeneration in patients with pseudarthrosis.
Methodology
Prospective, multicentre, open-label, non-randomized study. 12 patients with atrophic pseudarthrosis in long bones radiographically confirmed are included.
The purpose is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by means of radiological methods, based on the appearance of signs of bone callus formation up to 6 months after surgery.
Safety is determined by the number of severe adverse effects (AEs) related to the study and the percentage of patients with a related severe AE.
Efficacy is evaluated by radiographic criteria based on the appearance of signs of bone callus formation up to 6 months after surgery.
STUDY DESCRIPTION
Multicentre study
Development phase: II
Status: ongoing
PEI: 13-061
Nº Eudra-CT: 2013-000930-37
ClinicalTrials.gov: NCT0248336
Code: STEMQUIRI/12ES01
ClinicalTrials.gov: NCT02483364
Sponsor: Laboratorio SALVAT
CEIC: Centro Médico Teknon and Hospital Universitario La Paz
Control: Spanish Medicine Agency (AEMPS)
Investigators: L Orozco, A Moreno, R Soler Rich, F Soler, X Peirau, R Arriaza
Participating entities: Laboratorio SALVAT, Centro Médico Teknon, Hospital Universitario La Paz, Fundación Teknon, Histocell.
Funding: Laboratorio SALVAT
*HC-SVT-1001: autologous adult trunk mesenchymal cells of adipose tissue expanded and included in βtricalcium-phosphate biomaterial.
†HC-SVT-1002: allogenic adult trunk mesenchymal cells of adipose tissue expanded and included in βtricalcium-phosphate biomaterial.