NCT02748343

The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Defect
• Bone Nonunion

Interventions

Type	Name	Description
DEVICE	allograft bone	Use of the allograft bone to treat the bone defect in patients
DEVICE	tissue-engineered bone	Use of the tissue-engineered bone to treat the bone defect in patients

Timeline

• Start date: 2014-11-01
• Primary completion: 2019-09-01
• Completion: 2020-12-01
• First posted: 2016-04-22
• Last updated: 2017-11-17

Locations

1 site across 1 country: China