Congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
Conditions
Interventions
Artificial bones molded by ink-jet printing techniques are implanted to congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs
Sponsors
The University of Tokyo Hospital Division of Tissue Engineering
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases with congenital, traumatic, post-operative or tumorous defects/ deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
Exclusion criteria
Exclusion criteria: 1) Patients with complications including abnormal calcium metabolism or serious cardiac, hepatic or renal dysfunctions (grade 2 and grade 3 in the complication category) 2) Patients who have less-than-one-year prognoses of complications 3) Patients with severe complications who are not expected to endure tests necessary for clinical follow-up. 4) Patients with infections that may relapse. 5) Patients with collagen diseases. 6) Patients with histories of alcohol or drug dependency within the past 3 months 7) Patients with malignant neoplasms 8) Patients with possibile malignant neoplasms 9) Patients with proliferative diabetic retinopathy 10) Pregnant women, women suspected of being pregnant and breast-feeding women 11) Patients who cannot observe the instruction not to inflict excessive forces and burdens on affected areas after implantation and patients with mental disorders. 12) Patients who do not give informed consents 13) Patients who are judged to be inappropriate for the study by doctors in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of safety and efficacy of custom-made bone implants (3DB-01) | — |
Countries
Japan
Contacts
Public ContactYuichi Tei/Ung-il Chung
The University of Tokyo Hospital Division of Tissue Engineering
Outcome results
None listed