In patients undergoing maxillary sinus floor elevation (MSFE) for dental implant placement, bone substitutes are currently
evaluated as alternatives for autologous bone. However, bone substitutes have only osteoconductive properties and lack osteoinductive
potential. Therefore, this phase I study evaluated the potential additive effect on bone regeneration by the addition of freshly
isolated, autologous but heterologous stromal vascular fraction (SVF), which is highly enriched with adipose stromal/stem
cells when compared with native adipose tissue. From 10 patients, SVF was procured using automatic processing, seeded on either
β-tricalcium phosphate (n = 5) or biphasic calcium phosphate carriers (n = 5), and used for MSFE in a one-step surgical procedure.
Primary objectives were feasibility and safety. The secondary objective was efficacy, evaluated by using biopsies of the augmented
area taken 6 months postoperatively, concomitant with dental implant placement. Biopsies were assessed for bone, graft, and
osteoid volumes. No adverse effects were reported during the procedure or follow-up (≥3 years). Bone and osteoid percentages
were higher in study biopsies (SVF supplemented) than in control biopsies (ceramic only on contralateral side), in particular
in β-tricalcium phosphate-treated patients. Paired analysis on the six bilaterally treated patients revealed markedly higher
bone and osteoid volumes using microcomputed tomography or histomorphometric evaluations, demonstrating an additive effect
of SVF supplementation, independent of the bone substitute. This study demonstrated for the first time the feasibility, safety,
and potential efficacy of SVF seeded on bone substitutes for MSFE, providing the first step toward a novel treatment concept
that might offer broad potential for SVF-based regenerative medicine applications.