bone defect and bone non-union
Conditions
Interventions
treatment group:rapidly prepared bioactive materials as bone graft using bone marrow stem cells screen-and-enrich-and-combine(-biomaterials) circulating system(SECCS)
controlled group:autologous bone graft
Sponsors
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 15 to 65 years male and female; 2. patients require bone grafting including: (1) bone defect which need less than 15ml bone grafts; (2) bone non-union or delayed union; (3) spinal operation needing 5~60ml bone grafts; 3. Be willing sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. malignant tumor; 2. myelodysplastic syndrome; 3. infected disease; 4. high dose chemoradiotherapy; 5. blood system disease; 6. operation site with infection or Hemoculture positive recently; 7. Hb10 seconds and platelet less than 60×10^9/L 8. pregnant woman; 9. patients with decompensated cirrhosis,uremia or severe brain trauma; 10. patient paticipating in other clinial trials in the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| union rate;clinical union time; | — |
Secondary
| Measure | Time frame |
|---|---|
| bone callus amout;incidence rate of complication;enrichment rate of stem cells; | — |
Countries
China
Contacts
Public ContactYaoKai Gan
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed