|- candidate number||2103|
|- NTR Number||NTR714|
|- Date ISRCTN created||26-sep-2006|
|- date ISRCTN requested||13-sep-2006|
|- Date Registered NTR||26-mei-2006|
|- Secondary IDs||N/A |
|- Public Title||A clinical feasibility study to evaluate the effectiviness and safety of VivescOs TM as bone graft for reconstruction of intra-oral osseous defects.|
|- Scientific Title||A clinical feasibility study to evaluate the effectiviness and safety of VivescOs TM as bone graft for reconstruction of intra-oral osseous defects.|
|- hypothesis||Cultured mesenchymal stem cells differentiated into osteoblasts and seeded on scaffolds can induce bone formation.|
|- Healt Condition(s) or Problem(s) studied||Intra-oral bone defects, Tooth loss|
|- Inclusion criteria||Repair of the intra-oral defect was indicated as preparation for dental implant placement in a secondary stage.|
|- Exclusion criteria||1. Presence of local or systemic disease;|
2. Pregnancy, cancertherapy;
3. Previous participation in another trial within 30 days;
4. Known hypersensitivity for penicillin, streptomycin.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||8-nov-2000|
|- planned closingdate||21-jan-2003|
|- Target number of participants||10|
|- Interventions||"VisvescOs" and "tissue engineered bone".
"Preoperatively, 4 weeks before the
implantation procedure, a aspiration biopsy will be taken.|
Post-operatively patients will be evaluated using radiographic analysis by OphtoPantomoGrams (OPG), histological analysis by biopsy specimens and clinical evaluation of functionality, 3 months, 6 months, 9 months, 12 months and 15 months after surgery.
|- Primary outcome||Safety of VivescOs has been confirmed.|
|- Secondary outcome||Efficacy of VivescOs is doubted.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Gert Meijer|
|- CONTACT for SCIENTIFIC QUERIES|| Gert Meijer|
|- Sponsor/Initiator ||IsoTis NV |
(Source(s) of Monetary or Material Support)
|- Brief summary||To investigate the power of Bone Tissue Engineering, 10 patients with various intra-oral osseous defects were selected. After a bone marrow aspirate was taken, stem cells were cultured, expanded and grown for 7 days on a bone substitute in an osteogenic culture medium to allow formation of a layer of extracellular bone matrix. At the end of the procedure, this ?living bone substitute? was not only re-implanted in the patient, but simultaneously subcutaneously implanted in mice to prove its osteogenic potency.
In 7 patients, a viable ?living bone substitute? was successfully constructed, which was proven by bone formation after subcutaneous implantation in mice (ectopic bone formation). However, the same construct generally failed to form bone in the patient?s intra-oral osseous defects (orthotopic bone formation). Although biopsies, taken 4 months after reconstructing the intra-oral bone defect, showed bone formation in 3 patients, in only 1 patient bone formation was convincingly induced by the tissue engineered construct.
Although a bone substitute covered by osteogenic cells and extracellular bone matrix is capable of producing bone in a non-bone environment in mice, the same construct has hardly any potency to produce bone in an osseous defect in humans in the current clinical setting.
|- Main changes (audit trail)|
|- RECORD||26-mei-2006 - 20-mei-2008|