Bone defect and bone dysplasia in craniofacial region
Conditions
Interventions
In the operation room, the site of bone defect or bone dysplasia is exposed by incising the skin and the subcutaneous tissue. Periosteum is detached. One piece of AMED-Bone is placed on the site. At t
Sponsors
Hoshi Kazuto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient who meets all the criteria described below is included in the research. 1. A patient with defect or dysplasia of craniofacial bone (non-weight bearing site), who needs transplantation of bone less than about 10 mL (judged by X-ray or CT-scanning taken at a normal medical examination within 1 year before the time of obtaining informed consent). 2. A patient who can follow the schedule specified in the protocol. 3. A patient of 20 years or more at the time of obtaining informed consent. 4. A patient who can understand the contents of the research and give a written informed consent.
Exclusion criteria
Exclusion criteria: A patient who meets any of the criteria described below is excluded from the research. 1. A patient who is classified as III or more in ASA physical status classification. 2. A patient who has malignancy, or possibility of malignancy. 3. A patient who has ill-controlled diabetes mellitus. 4. A patient who has possibility of sepsis. 5. A patient who has infection with possibility of recurrence around the site of transplantation or collection of bone marrow fluid. 6. A patient who underwent surgery within 1 year at the site of the transplantation before transplantation of AMED-Bone+BM, or who is going to receive surgery at the site of the transplantation. 7. A patient who has diseases in bone marrow such as fibrosis, dysplasia or hematopoietic disorder. 8. A female patient who is pregnant, has possibility of pregnancy, is breast-feeding, or disagrees with contraception until 6 months after transplantation of AMED-Bone+BM. 9. A patient who, or whose relatives within the second degree, have present or past history of autoimmune diseases such as rheumatoid arthritis, psoriatic arthropathy, systemic or discoid lupus erythematosus, dermatomyositis, polymyositis, chronic thyroiditis, Graves' disease, polyarteritis, scleroderma, ulcerous colitis, Crohn's disease, Sjoegren syndrome, Reiter's syndrome, mixed connective-tissue disease, or relapsing polychondritis. 10. A patient with the history of anaphylaxis. 11. A patient with the history of hypersensitivity or allergy to collagen products, or possibility of them. 12. A patient who is receiving immunosuppressive agents. 13. A patient who is taking anti-coagulant agents and not able to withdraw them during surgery and 1 week after surgery not to affect coagulability. 14. A patient who has been enrolled in other clinical trials or clinical researches within 90 days before the time of obtaining informed consent. 15. A patient with mental disorders who cannot fill in the questionnaire adequately. 16. A patient whom the principal investigator or sub-investigators consider inadequate to enroll in this research by other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: adverse effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1)Evaluation for osteogenesis in the transplantation site by CT-scanning (Differences in CT values of before and after transplantation (1, 2, 3, 6 months and 1 and 2 years)) 2) Evaluation for osteogenesis in the transplantation site by X-ray (Qualitative evaluation comparing the images before and after transplantation (1, 2, 3, 6 months and 1 and 2 years)) 3) Evaluation of satisfaction with esthetic outcomes by DAS59 (Differences in the scores of before and after transplantation (3 and 6 months, and 1 and 2 years)) 4) Evaluation of depressiveness and QOL in physical and mental status by SDS (Differences in the scores of before and after transplantation (3 and 6 months, and 1 and 2 years)) | — |
Countries
Japan
Contacts
Public ContactAtsuhiko Hikita
The University of Tokyo Hospital
Outcome results
None listed