💬In plain words
What the trial is, and whether it could suit you
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.
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📋 Eligibility rules (as published)
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.
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