Onderzoek naar kaakbotophoging met kunstbot en stamcellen voor tandwortelimplantaten

- So far, ten patients have been uneventfully treated
- The one-step surgical procedure in clinical setting is feasible
- Safety: So far, no (serious) adverse effects have been observed during follow-up
- Efficacy of bone formation: currently being evaluated

For patients with maxillary atrophy, the distal area of the maxilla can be augmented by transplanting bone or bone substitutes to the bottom of the maxillary sinus in order to provide sufficient alveolar bone volume for implant placement. The sinus floor elevation (or sinus lift) model is unique since it allows histological examination of biopsies obtained during the preparation for dental implant placement. In this study, the currently used autologous bone grafts and bone substitute materials will be replaced by an osteoinductive implant consisting of a calcium phosphate carrier seeded with clinically relevant quantities of minimally manipulated, freshly isolated adipose tissue stem cells in a one-step surgical procedure. This novel concept can be performed in 2 hours within the surgical theatre using a CE-marked device, thus avoiding costly GMP stem cell expansions and second intervention. We hypothesize that the thus created bioactive implant will lead to faster and improved restoration of maxillary bone volume and functionality without the drawback of complications associated with the currently used implantation materials. If successful, this offers broad potential for other bone tissue engineering applications as well.

- Open Questionnaire and Physical examination: At screening/Inclusion, Baseline (Day 0), and at 1, 6, 9, and 18 months
- Laboratory parameters (Haematology, Serum chemistry): At screening/Inclusion, Baseline (Day 0), and at 1 and 6 months
- Overall AE and SAE: all visits

Adipose tissue aspiration followed by procurement of its stromal vascular fraction highly enriched for adipose stem cells, and subsequent combination with synthetic bone substitutes to generate bioactive material for sinus floor elevation