Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro to explore the effect of this tissue engineered bone in the clinical repair of long tubular bone defects in limbs.
Age: 18-55 years old, gender unrestricted;
Defective nonunion with bone loss exceeding 30% of the bone cross-section and a length of 2-3 cm;
Solitary bone cysts involving more than 50% of the bone cross-section.
Combined with local tumors, tuberculosis, infections or other bone-healing affecting lesions;
Systemic diseases affecting bone healing such as osteofibrous dysplasia, osteogenesis imperfecta, bone dystrophic diseases, and metabolic bone disorders;
Moderate-to-severe osteoporosis (BMD: T-score < -2.5);
Severe systemic conditions including systemic malnutrition, systemic infectious diseases, severe cardiopulmonary diseases, coagulation disorders, and major organ failure;
Single group
tissue-engineered bone
DeviceCommercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro
The scores of bone healing
The scores of bone healing are divided into three kinds: nonhealing: 0；delayed healing: 1; normal healing.
The adverse event incidence using tissue-engineered bone
The adverse event incidence of tissue-engineered bone
Bone union (bone healing) evaluation through modified lane and sandhu radiological scoring system
Evaluation of the bone regeneration in the area of intervention in comparison to baseline (V1), by means of X-ray and/or CT scan examination, on visits V1, V2 and V3. X-ray scoring systems have been implemented according to the criteria proposed by modified Lane and Sandhu Radiological Scoring System. This scoring system evaluates bone formation and union. To evaluate the bone formation, there is a scale with 5 points, from 0 to 4 (0=No evidence of bone formation-4=Bone formation occupying 100% of defect). To evaluate bone union, there is a scale with 3 points, from 0 to 2 (0=Non-union-2=Radiogrical union)
The scores of time of weight loading after operation
The scores of time of weight loading after operation are divided into three kinds: longer than six months: 0; longer than three months: 1; less than three months: 2
The scores of pain
The scores of pain after operation are divided into four kinds: severe: 0; moderate: 1; slight: 2; none: 3.
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