The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone
The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone
The purpose of this study is to compare use of a tissue-engineered bone to use of a standard
 allograft bone to treat bone defect in patients. The hypothesis is that use of the
 tissue-engineered bone is effective and safe to treat the bone defect in patients.
Patients with the bone defect without infection and sever system diseases will be recruited.

 The material selected as the scaffold for this study will be a porous β-tricalcium phosphate
 scaffold (β-TCP) scaffold and scaffold is custom-made according to the size and shape of bone
 defect after three-dimensional CT scan. Human BMSCs will be obtained and cultured before
 operation and 3.4×106 cells in 10ml serum-free medium will be seeded onto scaffold to
 construct the tissue engineered bone graft and co-cultured for two weeks.

 The implant operation will be carried out under the general anesthesia. The tissue engineered
 bone graft will be implanted into the bone defect area. The bone defect area will be covered
 with surrounding soft tissue and muscle to close the wound. Anti-inflammatory, repercussive
 and analgesic drugs will be used for 1 week.

 Patient will be hospitalized for 1 to 2 weeks after surgery. Blood routine examination,
 erythrocyte sedimentation rate, immunoglobulin, autoantibodies and clinical examination will
 be carried out for signs of pain, swelling, immune rejection and infection. Patient will be
 evaluated at 3 days，3, 6, 12, 18 and 22 months after operation by radiography;
 Three-dimensional CT scan will be also performed at regular intervals. The function of the
 body will be evaluated at regular intervals.
Inclusion Criteria:

 -  the patients with bone defect and bone nonunion caused by tumor or trauma

 -  the length of bone defect in long diaphysis is more than 4cm or more than half of the
 shaft diameter

 -  the size of bone defect is more than 5cmx5cm

 -  the patients are unable to use autologous bone graft or other treatments

 -  the patients request to use the treatment of tissue-engineered bone

 -  Supportive family with willingness to participate in completing questionnaires

 Exclusion Criteria:

 -  Patients with serious diseases such as hemorrhagic disorders, infection, tumor,
 contagion and so on.

 -  Patients who are pregnant

 -  Patients with serious abnormal cardiopulmonary function

 -  Patients disagree to use the tissue-engineered bone

 -  Patients are older than 60 years

 -  Patients who are regarded to be unqualified by investigator