Clinical trial NCT02748343: The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone
Official title: The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Bone Defect
Bone Nonunion
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The scores of bone healing
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: the adverse event incidence using tissue-engineered bone and allograft bone
timeFrame: within 24 weeks after surgical treatment of bone dect
Secondary outcomes:
measure: The scores of blood routine test
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of erythrocyte sedimentation rate(ESR)
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of C-reactive protein
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of the ratio of complement C3 to complement C4
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of immunoglobulin assay
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of duration of hospital stay
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: the scores of time of weight loading after operation
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of tumorigenesis
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of treatment course
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of number of operations
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of pain
timeFrame: within 48 weeks after surgical treatment of bone dect
measure: The scores of wound healing of soft tissue
timeFrame: within 48 weeks after surgical treatment of bone dect
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Orthopedics, Xijing Hospital, The Fourth Military Medical University
state: Shanxi
Study officials:
References: