The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone
NCT ID: NCT02748343
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2014-11-30
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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allograft bone
traditional allograft bone
allograft bone
Use of the allograft bone to treat the bone defect in patients
tissue-engineered bone
tissue-engineered bone
tissue-engineered bone
Use of the tissue-engineered bone to treat the bone defect in patients
Interventions
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allograft bone
Use of the allograft bone to treat the bone defect in patients
tissue-engineered bone
Use of the tissue-engineered bone to treat the bone defect in patients
Eligibility Criteria
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Inclusion Criteria
* 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 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
1 Year
60 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Locations
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Department of Orthopedics, Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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long bi, MD,PHD
Role: primary
Other Identifiers
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bilong11
Identifier Type: -
Identifier Source: org_study_id