Bone Nonunion Clinical Trial
Official title:
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02815423 -
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04997590 -
Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing
|
N/A |