Bone regeneration with autologous bone marrow cells (CO2-1) and bovine bone mineral (Bio-Oss®) in surgical treatment of upper jaw edentulism
Objectives
Clinical trial to assess the safety and find evidence of efficacy of treatment with expanded mesenchymal stem cells grafts for maxillary bone regeneration.
Methodology
Phase I-II, open-label, prospective and unicentric clinical trial.
A graft consisting of expanded bone marrow mesenchymal stem cells was implanted in bovine bone biomaterial.
Results
Safety
The procedure proved effective, no adverse or toxic effects were recorded.
Efficacy
A higher quality of newly formed bone tissue was evident in the areas where the biograft was implanted with expanded mesenchymal stem cells, compared to the control areas where only biomaterial was implanted.
Conclusions
The therapy is safe and effective. Implantation of a biograft with expanded mesenchymal stem cells improves bone quality and could be beneficial in patients with progressive maxillary atrophy due to loss of dental pieces that require implant application.
STUDY DESCRIPTION
Unicentric study
Development phase: I-II
Status: completed
Sponsor: Instituto de Cirugia Maxilofacial Centro Médico Teknon
CEIC: Centro Médico Teknon
Control: Organización Catalana de Trasplantes (OCATT)
Investigators: F Hernández Alfaro, C Martí, L Orozco, L Rodriguez, ML Mariñoso, JM Hock
Scientific collaboration: R Soler Rich
Cellular Production Unit: Centre de Teixits i Terapia Cel·lular (BST)
Participating entities: Instituto de Cirugía Maxilofacial Centro Médico Teknon; ITRT-Centro Médico Teknon; Banc de Sang i Teixits (BST); Hospital Ntra. Sra. del Mar; Aastrom Biosciencies Inc. (Michigan-USA).
Funding: Aastrom Biosciencies Inc. (Michigan, EUA)