The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Bone Defect; Bone Nonunion

Treatments: Device: tissue-engineered bone; Device: allograft bone

Study type: Interventional

Funder types: Other

Identifiers

NCT02748343

bilong11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

allograft bone

Active Comparator group

Description:

traditional allograft bone

Treatment:

Device: allograft bone

tissue-engineered bone

Experimental group

Description:

tissue-engineered bone

Treatment:

Device: tissue-engineered bone