NCT07101562

Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Avascular Necrosis of Femur Head

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Xinxiang Medical College · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The commercial decalcified bone scaffold combined with the patient's autologous bone marrow mesenchymal stem cells was used for in vitro culture to form tissue-engineered bone, and the effect of this tissue-engineered bone in early non-traumatic femoral head necrosis was explored.

Detailed description

Avascular necrosis of the femoral head progresses rapidly, and most patients experience femoral head collapse within 1 to 4 years. Therefore, early intervention in the early stage of avascular necrosis of the femoral head is crucial for preserving the femoral head. Currently, core decompression is commonly used in clinical practice for early avascular necrosis of the femoral head. The principle is to drill holes and partially remove the necrotic lesions to reduce the pressure within the femoral head, increase blood supply, stimulate bone regeneration, thereby alleviating pain and delaying or reversing the progression of avascular necrosis of the femoral head. After the necrotic area of the femoral head is removed, bone grafting is often required to prevent complications such as femoral neck instability, femoral neck fractures, and femoral head collapse. There are many types of bone grafts, such as autologous bone, allogeneic bone, and artificial bone. However, autologous bone causes damage to the donor site and provides limited bone tissue; allogeneic bone has limited bone repair ability due to the lack of biological activity. Tissue engineering technology uses tissue engineering methods to transplant a composite of seed cells, growth factors, and scaffold materials to the bone defect site, providing good structural support and promoting bone tissue regeneration, thereby repairing the necrotic area of the bone and blood vessels. It has the advantages of no rejection reaction, unrestricted material acquisition, sufficient bone mass for cultivation, and easy survival, providing a new direction for the treatment of avascular necrosis of the femoral head. This study aims to evaluate the clinical effect of tissue-engineered bone in repairing early non-traumatic aseptic necrosis of the femoral head and provide a basis for the treatment of aseptic necrosis of the femoral head.

Conditions

• Avascular Necrosis of Femur Head

Interventions

Type	Name	Description
DEVICE	Tissue-engineered bone	Tissue-engineered bone with autologous bone marrow mesenchymal stem cells

Timeline

• Start date: 2025-07-30
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: China