Prospective study. Surgical treatment of hypotrophic diaphyseal pseudarthrosis and C23 and C33 diaphyseal fractures (according to AO/ASIF classification), using autologous bone marrow cells (C02-1), β-tricalcium phosphate and Platelet-rich plasma
Objectives
Clinical trial to assess the efficacy, safety and effects of TRC* infiltration on bone regeneration in pseudarthrosis.
Methodology
Phase I-II, open-label, prospective and multicentre clinical trial. 6 patients with pseudoarthrosis were included.
Results
Safety
The procedure proved to be safe and effective. Safety controls carried out after 2 years of treatment did not register adverse or toxic effects, nor any complications attributable to the cellular treatment.
Efficacy
The 6 patients were cured before 6 months post-intervention. Radiographic controls showed a good remodelling of the “bone callus” for healing.
Conclusions
The good results obtained in this pilot trial motivated the continuation of studies with expanded mesenchymal stem cells for bone regeneration.
STUDY DESCRIPTION
Multicentre study
Development phase: I-II (pilot)
Status: completed
Sponsor: Hospital General de l’Hospitalet
CEIC: Hospital General de l’Hospitalet
Control: Organización Catalana de Trasplantes (OCATT)
Investigators: C Solano, L Orozco, J Girós
Scientific collaboration: R Soler, L Orozco, J Girós
Cellular Production Unit: Centre de Teixits i Terapia Cel·lular (BST)
Participating entities: Hospital General de l’Hospitalet; Hospital de Barcelona SCIAS; Centro Médico Teknon
Funding: Aastrom Biosciencies Inc. (Michigan, USA)
*TRC: Tissue Repair Cells. Autologous Bone Marrow Progenitor Cells expanded with the Aastrom Replicell™ system