tissue-engineered bone: Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age: 18-55 years old, gender unrestricted;
2. Defective nonunion with bone loss exceeding 30% of the bone cross-section and a length of 2-3 cm;
3. Solitary bone cysts involving more than 50% of the bone cross-section.
Exclusion Criteria:
1. Combined with local tumors, tuberculosis, infections or other bone-healing affecting lesions;
2. Systemic diseases affecting bone healing such as osteofibrous dysplasia, osteogenesis imperfecta, bone dystrophic diseases, and metabolic bone disorders;
3. Moderate-to-severe osteoporosis (BMD: T-score \< -2.5);
4. Severe systemic conditions including systemic malnutrition, systemic infectious diseases, severe cardiopulmonary diseases, coagulation disorders, and major organ failure;
5. Complicated with severe brain trauma;
6. Heavy smoking, drug abuse, alcoholism, or other harmful addictions;
7. Psychiatric disorders or patients with menopausal symptoms;
8. Concurrent participation in other studies or recent completion (within 4 weeks) of other clinical trials;
9. Pregnancy, lactation, or planned pregnancy within one year after initial enrollment;
10. Psychological conditions impairing treatment compliance;
11. Congenital malformations of vital organs or other systems;
12. Nonunion caused by malignant tumor resection;
13. Refusal to accept tissue-engineered bone repair protocol.
Primary outcome measure(s)
The scores of bone healing — About 360 days after surgical treatment of bone defect 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 — About 360 days after surgical treatment of bone defect The adverse event incidence of tissue-engineered bone
Bone union (bone healing) evaluation through modified lane and sandhu radiological scoring system — At the end of visits 1, 2, 3 (respectively performed at screening and 7, 90, 360 days after the surgery) 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)
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang
Henan
Recruiting
More The First Affiliated Hospital of Xinxiang Medical College trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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